Conference Chairs Blair S. Lewis Roberto de Franchis Gèrard Gay

Conference Chairs Blair S. Lewis Roberto de Franchis Gèrard Gay
4/6/2017 Consensus Report the 5th International Conference on Capsule Endoscopy™ Conference Chairs Blair S. Lewis Roberto de Franchis Gèrard Gay

ICCE 2006 Two clinical congresses in 2006 Combined statistics
4/6/2017 ICCE 2006 Two clinical congresses in 2006 Boca Raton, Florida, USA March 6-7, 2006 Paris, France June 9-10, 2006 Combined statistics 622 attendees 40 countries represented 146 abstracts presented 89 oral presentations

4/6/2017 Consensus Activities Reviewed last year’s data and updated ICCE 2005 Consensus Drafted paper for peer-reviewed publication in Endoscopy this fall Consensus Topics IBD Esophagus Tumors Bleeding Celiac Preps/Prokinetics

Inflammatory Bowel Disease (IBD)
4/6/2017 Inflammatory Bowel Disease (IBD) June 2006 Panel Co-Chairmen E. Seidman I. Bjarnason Panel Members: J. Leighton, P. Legnani, M. Gassull, J.F. Columbel, V. Manoury, A. Kornbluth

Capsule Endoscopy (CE) for IBD:
4/6/2017 IBD Consensus Capsule Endoscopy (CE) for IBD: Higher sensitivity for assessing small bowel mucosal lesions compared to other imaging techniques

Triester et al Am J Gastroenterol 2006;101:954-964
4/6/2017 Meta-analysis of Prospective Comparative Crohn’s Disease Studies: CE vs. Other Modalities Established or Suspected n Published Study Established/Suspected 3 Costamagna 2002 Established 17 Heigh 2003 19 Bloom 2003 23 Buchman 2003 5 Goelder 2003 8 Voderholzer 2003 21 Chong 2003 35 Eliakim 2004 47 Toth 2004 31 Dubcenco 2004 Marmo 2004 11 studies, n=223 Triester et al Am J Gastroenterol 2006;101:

4/6/2017 CE vs. SB Radiography : : Study IY (random) Incremental Yield (random) 95% CI 95% CI Costamagna 2002 0.33 [-0.42, 1.09] Bloom 2003 0.37 [0.08, 0.66] Chong 2003 0.48 [0.22, 0.73] Heigh 2003 0.47 [0.17, 0.77] Buchman 2004 0.00 [-0.27, 0.27] Dubcenco 2004 0.61 [0.42, 0.81] Eliakim 2004 0.54 [0.35, 0.74] Marmo 2004 0.53 [0.26, 0.80] Toth 2004 0.34 [0.17, 0.51] Total (95% CI) 0.42 [0.30, 0.54] Total yield: 66% (CE), 24% (SB radio) Test for heterogeneity: P = 0.03, I² = 52.1% Test for overall effect: P < -1 -0.5 0.5 1 Higher yield SB radiography Higher yield CE Triester et al Am J Gastroenterol 2006;101:

4/6/2017 CE vs. Ileoscopy Study IY (fixed) IY (fixed) 95% CI 95% CI Bloom 2003 0.05 [-0.26, 0.37] Heigh 2003 0.06 [-0.26, 0.37] Dubcenco 2004 0.32 [0.09, 0.55] Toth 2004 0.11 [-0.09, 0.30] Total (95% CI) 0.15 [0.02, 0.27] Total yield: 61% (CE), 46% (Ileoscopy) Test for heterogeneity: P = 0.38, I² = 2.1% Test for overall effect: P = 0.02 -1 -0.5 0.5 1 Higher yield Ileoscopy Higher yield CE Triester et al Am J Gastroenterol 2006;101:

CE vs. CT Enterography (CTE)
4/6/2017 CE vs. CT Enterography (CTE) Study IY (fixed) IY (fixed) 95% CI 95% CI Heigh 2003 0.18 [-0.14, 0.50] Voderholzer 2003 0.00 [-0.42, 0.42] Eliakim 2004 0.57 [0.38, 0.76] Total (95% CI) 0.38 [0.23, 0.54] Total yield: 75% (CE), 37% (CTE) Test for heterogeneity: P = 0.01, I² = 76.2% Test for overall effect: P < -1 -0.5 0.5 1 Higher yield CTE Higher yield CE Triester et al. Am J Gastroenterol 2006;101:

Summary of Incremental Yield (IY) of CE Over Other Modalities
4/6/2017 % IY for CE (95% CI) Total yield other modality (%) Total yield CE (%) 42 ( ) 24 66 vs. SB Radiography 15 ( ) 46 61 vs. Ileoscopy 38 ( ) 37 75 vs. CT Enterography 44 ( ) 7 51 vs. Push Enteroscopy 20 ( ) 40 60 vs. Small Bowel MRI Triester et al. Am J Gastroenterol 2006;101:

CE vs. Barium Radiography
4/6/2017 CE vs. Barium Radiography Suspected CD subgroup Study IY (random) [95% CI] IY (random) [95% CI] Costamagna 2002 0.00 [-0.85, 0.85] Dubcenco 2004 0.38 [-0.04, 0.79] Eliakim 2004 0.54 [0.35, 0.74] Toth 2004 0.17 [-0.02, 0.37] Chong 2005 0.00 [-0.11, 0.11] Hara 2005 0.25 [-0.16, 0.66] Total (95% CI) 0.24 [-0.03, 0.51] Total yield (fixed): 43% (CE), 13% (barium radiography) Test for heterogeneity: P < 0.001, I² = 85.6% Test for overall effect: P = 0.09 -1 -0.5 0.5 1 Yield higher in barium radiography Yield higher in capsule endoscopy Established CD subgroup Study IY (random) [95% CI] IY (random) [95% CI] Costamagna 2002 0.50 [-0.21, 1.21] Buchman 2004 0.03 [-0.20, 0.27] Dubcenco 2004 0.70 [0.49, 0.90] Marmo 2004 0.45 [0.23, 0.67] Toth 2004 0.61 [0.35, 0.87] Chong 2005 0.62 [0.38, 0.86] Hara 2005 0.67 [0.34, 0.99] Total (95% CI) 0.51 [0.31, 0.70] Total yield (fixed): 78% (CE), 32% (barium radiography) Test for heterogeneity: P = 0.001, I² = 72.9% Test for overall effect: P < 0.001 -1 -0.5 0.5 1 Yield higher in barium radiography Yield higher in capsule endoscopy

CE vs. CT Enterography (n=58 pts) CE detects more proximal disease
4/6/2017 CE vs. CT Enterography (n=58 pts) CE detects more proximal disease + exams In some studies where the divided disease by location, it is clear that CE is detecting more disease in the prox and mid small bowel than CT enterography while the exams are pretty similar for detection of disease in the term ileum. Voderholzer et al. Gut 2005;54: Hara et al. Radiology 2006;238(1):

MR Enteroclysis (n=18 pts)
4/6/2017 MR Enteroclysis (n=18 pts) + exams MR enteroclysis studies also illustrate this difference for detecting proximal disease compared to CE. Golder et al. Int’l J of Colorectal Disease 2006;21(2):97-104

Capsule endoscopy (CE) vs. other imaging:
4/6/2017 IBD Consensus Capsule endoscopy (CE) vs. other imaging: Limitations The available data are more evidence based for known, non-stricturing CD than for suspected CD. No “gold standard” available for CD. CE is superior to CT enterography & MRI; particularly for proximal - mid small bowel CD. CE demonstrates mucosal lesions missed by other imaging. No single test is available for diagnosing CD.

Mascarenhas-Saraiva M, et al. ICCE 2005 AB 115
4/6/2017 IBD Consensus CE may be useful in the study of indeterminate colitis: 22 pts with colonic IBD underwent CE. 9 (40%) with “colitis” were found to have small bowel lesions. 27 pts with IC underwent CE. 8 (29%) had small bowel lesions. 10 pts with IC underwent CE. 4 (40%) had small bowel lesions. Mow WS, et al. CGH 2004;2:31-40 Mascarenhas-Saraiva M, et al. ICCE 2005 AB 115 Hume G, et al. ICCE 2004 AB 1054

IBD Consensus 31 patients with IC and known serology
4/6/2017 IBD Consensus 31 patients with IC and known serology CE and serology equally sensitive (61%). CE was more sensitive than ASCA or OMP-C in diagnosing small bowel CD. Conclusion: CE was superior to CD-like markers in identifying small bowel disease in IC patients. Lo SK, et al., Gastrointest Endosc 2003;57(5):AB 1889

Role of CE in assessing for early post- operative recurrence
4/6/2017 IBD Consensus Role of CE in assessing for early post- operative recurrence 32 post-op ileocecal resection CE & ileo-colonoscopy < 6 months Recurrence: 21/32 – sensitivity Ileo-colonoscopy 90% vs. 62% for CE CE identified more proximal disease in 2/3 of cases. CE may be useful as a first line evaluation of post-operative recurrence due to its good tolerability. Bourreille et al Gut 2006;55:

IBD Consensus Role of CE in assessing for early
4/6/2017 IBD Consensus Role of CE in assessing for early post-operative recurrence 14 patients post-op ileocecal resection x 1 yr CE & small bowel US compared in 13 (1 stricture) Recurrence: 12/13 by colonoscopy US: 13/13 ( 1 false +) CE: 12/13 (all true +) CE represents an alternative minimally-invasive technique for assessing CD recurrence in patients under follow-up of ileo-colonic resection. Biancone et al; Gastroenterology 2006;130(4):Supp S2: AB S1336

Capsule endoscopy (CE) for suspected IBD:
4/6/2017 IBD Consensus Capsule endoscopy (CE) for suspected IBD: Useful and safe in patients with suspected Crohn’s disease and negative endoscopic & small bowel imaging Evidence: based mainly on retrospective studies; more prospective data needed. Positive CE findings not well defined (lack of validated scoring index). Has potential to affect patient management. Scoring index may provide diagnostic threshold.

Capsule Endoscopy: Are All Ulcers Crohn’s?
4/6/2017 Capsule Endoscopy: Are All Ulcers Crohn’s? A B C Which image is an ulcer from Crohn’s disease? The answer is all three. However, patient history will define if another cause, such as NSAID damage or radiation enteropathy caused the ulceration.

4/6/2017 IBD Consensus Standardized CE scoring index of disease severity to differentiate normal from small bowel inflammatory disorders in development. Correlation of CE index with clinical disease activity scores needed. CE scoring index may not distinguish between various causes of inflammation (NSAIDs, radiation enteropathy).

Scoring Index Parameters Scale Villous Appearance Ulceration Stenosis
4/6/2017 Scoring Index Parameters Villous Appearance Ulceration Stenosis Scale Normal, edematous Number - single, few, multiple Distribution - localized, patchy, diffuse Longitudinal extent - short, long, whole segment Ulcer size - based on amount of bowel wall circumference involved Stenosis - ulcerated or not, traversed or not

Example of Score Template
4/6/2017 Example of Score Template Global Disease Assessment: Normal, Mild, Moderate/Severe

Suspected Crohn’s Disease
4/6/2017 Suspected Crohn’s Disease Patients with characteristic GI symptoms of CD (at least 1 from “A”), and with at least one of the criteria under “B”, “C” or “D”: Characteristic GI Symptoms (anti-tTG negative) Chronic abdominal pain Chronic diarrhea Significant weight loss Growth failure Extra-intestinal Symptoms Unexplained recurrent fever Arthritis/arthralgias Pyoderma/erythema nodosum Aphthous stomatitis Perianal disease PSC/recurrent cholangitis Inflammatory Markers Iron deficiency anemia Thrombocytosis or leukocytosis Elevated ESR or CRP Hypoalbuminemia Positive IBD serology Fecal markers: lactoferrin, alpha-1 antitrypsin, calprotectin; heme +; leucocyte + Abnormal, Non-diagnostic Imaging

Negative ileocolonoscopy
4/6/2017 Suspected SB CD Positive ileocolonoscopy Negative ileocolonoscopy or unsuccessful No obstruction Possible or known obstruction Patency capsule either/or No obstruction Obstruction Capsule endoscopy CTE/MRE (SBFT) Presence of SBCD Treat accordingly Figure 1. Algorithm for the approach to suspected small bowel Crohn’s Disease (CD). The absence of any mucosal lesions demonstrated by a complete assessment of the small bowel by capsule endoscopy excludes active CD of the small bowel. Patients with symptoms suggestive of obstruction, or known to have a stenosis should either undergo a patency capsule exam or evaluation by CTE or MRE prior to capsule endoscopy. Abbreviations: SB CD=small bowel Crohn’s Disease, CTE=CT enterography, MRE=MR enterography, SBFT=small bowel follow through.

Capsule Retention and CD
4/6/2017 Capsule Retention and CD Type Capsule Retention (%) Patients (n) Author Type Known 4 50 Mow Suspected 21 Herrerias 17 Fireman 20 Eliakim 5 Sant’Anna 6.7 30 Buchman Known strictures 13.0 38 Chiefetz

Capsule Retention in Crohn’s Disease
4/6/2017 Capsule Retention in Crohn’s Disease In patients with Established CD, the risk is 5%, despite absence of strictures on SBFT. In cases with Suspected CD: The risk is low with negative SBFT. If no SBFT, in the absence of obstructive symptoms, risk is yet unknown.

4/6/2017 Conclusions CE has a higher sensitivity for assessing small bowel mucosal lesions compared to other imaging techniques. CE is helpful diagnosing suspected Crohn’s in the pediatric population. CE is superior to CT enterography & MRI; particularly for proximal - mid small bowel CD. CE may be useful as a first line evaluation of postoperative recurrence of CD. CE can detect small bowel lesions in a significant number of patients with indeterminate colitis and may alter disease management. CE is useful and safe in patients with suspected Crohn’s disease and negative endoscopic & small bowel imaging.

Esophagus June 2006 Panel Co-Chairmen R. Eliakim G. Eisen
4/6/2017 Esophagus June 2006 Panel Co-Chairmen R. Eliakim G. Eisen Panel Members: J.P. Galmiche, T. Roesch, F. Schnoll-Sussman, J. Herrerias, V.K. Sharma, E. Coron

Consensus Statement - Esophageal Capsule Endoscopy (ECE)
4/6/2017 Consensus Statement - Esophageal Capsule Endoscopy (ECE) A new approach to esophageal diagnostics Simple and easy Patient-friendly Screening tool for esophageal diseases Encouraging initial clinical data Esophageal Varices Barrett’s Esophagus

Consensus Statement – Varices
4/6/2017 Consensus Statement – Varices Esophageal varices (EV) are a serious consequence of portal hypertension (PHT). In patients with cirrhosis, the incidence of EV increases 5% per year and the rate of progression from small to large varices is 5-10%. Increasing size of varices is associated with increased wall tension leading to rupture and bleeding. AASLD/UK guidelines recommend endoscopic screening of patients with cirrhosis for varices and treatment of patients with medium/large varices to prevent bleeding. Eisen G, De Franchis R, Eliakim R, Zaman A, Schwartz J, Faigel D, Rondonotti E, Villa F, Weizman E, Yassin K. Preliminary results of International Multicenter Trial. 32 patients reported. ICCE 2006 AB 20154

Consensus Statement – Varices (continued)
4/6/2017 Consensus Statement – Varices (continued) Recommended endoscopic screening intervals are 1-3 years, depending on presence/absence of varices and whether patient has compensated/decompensated liver disease. Endoscopic surveillance is performed in patients after obliteration of varices. This patient population could benefit from a non-invasive diagnostic test that does not require sedation. These recommendations/practices represent a potentially large endoscopic burden. Eisen G, De Franchis R, Eliakim R, Zaman A, Schwartz J, Faigel D, Rondonotti E, Villa F, Weizman E, Yassin K. Preliminary results of International Multicenter Trial. 32 patients reported. ICCE 2006 AB 20154

EV Screening Pilot Trial
4/6/2017 EV Screening Pilot Trial Initial pilot trial – EV screening with ESO Prospective blinded, 3 center study 32 patients – enriched population with surveillance No complications, no retention Japanese endoscopic grading system F0 = none F1 = small F2 = medium F3 = large Modified classification for current trial None/small/medium-large Medium-Large > 25% circumference Eisen G, Eliakim R, Zaman A, Schwartz J,Faigel D, Rondonotti E, Villa F, Weizman E, Yassin K, de Franchis R. Endoscopy 2006:38:1-5

Comparison of PillCam ESO and EGD: Esophageal Varices
4/6/2017 Comparison of PillCam ESO and EGD: Esophageal Varices NPV PPV Specificity Sensitivity Study Design # Patients Reference 57% 100% 81% Prospective Blinded 21 Study 1 74% 94% 87% 97 Study 2 96% 89% 32 Study 3 1.Lapalus MG. Endoscopy 2006;38:36-4 2. Eisen GM, de Franchis R. Interim Analysis of the Evaluation of PillCam ESO in the Detection of Esophageal Varices AB 20154 3.Eisen G, de Franchis R, Eliakim R, Zaman A, Schwartz J, Faigel D, Rondonotti E, Villa F, Weizman E, Yassin K, Endoscopy 2006;38(1):1-5

Esophageal Image Spectrum
4/6/2017 Esophageal Image Spectrum

Barrett’s Esophagus 4/6/2017
The normal, stratified squamous epithelium of the esophagus has a gray appearance at endoscopy. The epithelium of Barrett’s esophagus is typically “salmon-pink” in color. Often, as in the case illustrated here, there is a clear distinction between the two. Sometimes, it is not as obvious.

Epidemiology in Barrett’s Esophagus
4/6/2017 Epidemiology in Barrett’s Esophagus 7% of US Population have daily GERD Symptoms 10% of Chronic GERD Patients have Barrett’s esophagus Notes: Based on an autopsy series, Cameron et al. estimated the prevalence of traditional BE (columnar epithelium 3 cm in length) in the general population to be 376 cases per 100,000 population. The primary risk factor for the development of BE is GERD. GERD occurs daily in 7% of the US population. Approximately 10-12% of patients with GERD will be found to have BE at the time of endoscopy. The presence of BE is associated with a fold increased risk for the development of adenocarcinoma of the esophagus. References: Cameron AJ, Zinsmeister AR, Ballard DJ, Carney JA. Prevalence of columnar-lined (Barrett's) esophagus. Comparison of population-based clinical and autopsy findings. Gastroenterology 1990; 99: Locke III et al. Prevalence and Clinical Spectrum of Gastroesophageal Reflux: A Population-Based Study in Olmsted County, Minnesota. Gastro 1997;112: Falk GW. Endoscopic Surveillance of Barrett’s Esophagus: Risk Stratification and Cancer Risk. Gastro Endosc 1999;49(3):S Risk of esophageal cancer in Barrett’s esophagus 30-60 times > general population up to 2% of patients with BE Locke III et al. Gastro 1997: 112: Falk GW. Gastro Endosc 1999; 49(3):S29-34.

Screening for Barrett’s Esophagus
4/6/2017 Screening for Barrett’s Esophagus Adenocarcinoma is a lethal disease. GERD is a firmly established risk factor for this cancer. Barrett’s esophagus, a premalignant precursor, is firmly associated with GERD symptoms, and is clearly associated with an increased risk of cancer (RR X general population).

Multi-center Study Overview
4/6/2017 Multi-center Study Overview Primary aims Accuracy of ECE compared with EGD for the diagnosis of esophageal pathology in patients with chronic GERD symptoms Specificity, sensitivity, PPV, NPV Safety and adverse events of ECE Secondary aims Assess capability of ECE to identify presence of Barrett’s esophagus in patients undergoing surveillance endoscopy Assess patient satisfaction with both procedures Multi-site: Prospective 7-center international study Israel (3), USA (3), Germany (1) Inclusion criteria Aged 18 years or older Confirmation of 1 of the following: Histologic confirmation of Barrett's esophagus undergoing surveillance endoscopy Chronic GERD symptoms undergoing upper endoscopy for the evaluation of GERD The authors hypothesized that in patients with GERD, esophageal imaging with ECE would be as accurate as conventional upper endoscopy in detecting esophageal pathology Seven medical centers enrolled patients into this study Enrollment into the study was based on the following inclusion criteria: Patients who were aged 18 years or older Patients who had histologic confirmation of Barrett’s esophagus and were undergoing surveillance endoscopy, or had chronic GERD symptoms without prior upper endoscopy and had undergone upper endoscopy for the evaluation of GERD Patients who were able to give consent Patients who were eligible and willing to undergo upper endoscopy Patients who had no contraindications to ECE Reference Eliakim R et al. Paper presented at the 69th Annual Scientific Meeting of the American College of Gastroenterology; November 1, 2004; Orlando, Fla. Eliakim R et al. J Clin Gastroenterol 2005;39:

Patient Enrollment 109 patients enrolled 1 unable to swallow capsule
4/6/2017 Patient Enrollment 109 patients enrolled 1 unable to swallow capsule 2 technical difficulties 106 included in per-protocol statistical analysis One hundred nine patients were enrolled into this study. One patient was unable to swallow the capsule, and in 2 cases technical problems resulted in an unreliable sequence of images (large gaps within the sequence of frames captured). Therefore, 106 patients (59 [56%] men; age = 51 [mean] ± 15.7 [standard deviation] years; weight = 80.8 ± 15.8 kg; height 171 ± 10.5 cm) were included in a per-protocol statistical analysis. Reference Eliakim R et al. Paper presented at the 69th Annual Scientific Meeting of the American College of Gastroenterology; November 1, 2004; Orlando, Fla. 93 (88%) endoscoped for GERD symptoms 13 (12%) for surveillance of Barrett’s esophagus Eliakim R et al. J Clin Gastroenterol 2005;39:

Methods ECE swallowed using standardized ingestion protocol.
4/6/2017 Methods ECE swallowed using standardized ingestion protocol. Blinded investigator reviewed ECE videos. Upper endoscopy performed on the same day following ECE. Adjudication committee arbitrated if discrepancy between procedures was noted. Barrett’s cases were not biopsied for confirmation. The patient was instructed to fast for 5 hours prior to arriving at the facility. The patient was then asked to swallow the esophageal capsule using a standardized ECE ingestion protocol An investigator, blinded to the patient’s history and the diagnostic findings of the upper endoscopy, reviewed the ECE videos and documented the findings Upper endoscopy was performed on the same day following the ECE All pathology detected in the esophagus during the endoscopy was photographed, printed, and documented in the case report form. The investigator obtained endoscopic biopsies at their discretion as clinically indicated One week following the ECE, the patients were contacted to confirm excretion of capsule and to document any study-related adverse events An adjudication committee, comprising 3 expert GI endoscopists, was used whenever a discrepancy between the ECE and conventional endoscopy was noted. The gold standard in this study was defined as either the findings noted at the time of the EGD/biopsy or the decision of the adjudication committee following review of the endoscopic findings and photographs and ECE results Reference Eliakim R et al. Paper presented at the 69th Annual Scientific Meeting of the American College of Gastroenterology; November 1, 2004; Orlando, Fla. Eliakim R et al. J Clin Gastroenterol 2005;39:

Multi-center Study Results: Esophagitis
4/6/2017 Multi-center Study Results: Esophagitis EGD + - ECE 33 1 4 68 Sensitivity 89% Specificity 99% Positive Predictive Value (PPV) 97% Negative Predictive Value (NPV) 94% Adjudicated results Eliakim R, Sharma VK et al. In press. J Clin Gastro

Multi-center Results: Barrett’s Esophagus
4/6/2017 Multi-center Results: Barrett’s Esophagus EGD + - ECE 32 1 72 Sensitivity 97% Specificity 99% Positive Predictive Value (PPV) Negative Predictive Value (NPV) Adjudicated results Eliakim R, Sharma VK et al. In press. J Clin Gastro

ECE Clinical Trials Barrett’s Esophagus
4/6/2017 ECE Clinical Trials Barrett’s Esophagus Feasibility Trial 3rd ESO Trial # of Patients 17 42 Investigators Eliakim, Yassin, Shlomi, Suissa, Eisen Koslowsky, Jacob, Eliakim, Adler Adjudication Panel no Sensitivity 100% Specificity 80% Publication APT 2004;20:1-7 Endoscopy 2006;38 (1):27-30

ECE Clinical Trial Data: Barrett’s Esophagus
4/6/2017 ECE Clinical Trial Data: Barrett’s Esophagus NPV PPV Specificity Sensitivity # Patients Reference 89% 56% 84% 67% 58 VA Mason Trial 1 74% 86% 73% 32 Kansas Trial 2 1.Lin et al. Blinded Comparison of Esophageal Capsule Endoscopy vs. Conventional Endoscopy for Diagnosis of Barrett’s Esophagus in Patients with Chronic Gastroesophageal Reflux GIE ( in Press) 2.Sharma et al Gastroenterology 2006;130(4) April AB S1812

4/6/2017 Conclusions ECE does offer a minimally invasive method to screen for esophageal varices and portal hypertensive gastropathy. ECE does have a role in the evaluation of patients with esophageal disease that would otherwise avoid traditional testing methods. Large scale studies are needed to confirm outcomes.

GI Bleeding June 2006 Panel Co-Chairmen M. Pennazio I. Gralnek
4/6/2017 GI Bleeding June 2006 Panel Co-Chairmen M. Pennazio I. Gralnek Panel Members: M. Delvaux, N. Reddy S. Bar Meir, I. Demedts, M. Keuchel

Panel Participants (Boca Raton/Paris)
4/6/2017 Panel Participants (Boca Raton/Paris) Martin Keuchel Ingrid Demedts Simon Bar-Meir Nageshwar Reddy Michael Delvaux Scott Ketover Morry Moskovitz Shenan Abey Colm O’Morain

Value of CE for Obscure GI Bleeding
4/6/2017 Value of CE for Obscure GI Bleeding CE is a valuable diagnostic modality in evaluating obscure GI bleeding. Key advantages of CE include: ability to image entire small bowel; ability to review and share images; patient preference; safety profile; ability to conduct in variety of settings; clarity of image comparable to other endoscopy. 2 meta-analyses support role of CE in OGIB*. *Triester et al. Am J Gastro 2005;100: *Marmo et al. APT 2005;22:

4/6/2017 Value of CE for Obscure GI Bleeding Marmo et al. APT 2005;22:

4/6/2017 Value of CE for Obscure GI Bleeding Triester et al. Am J Gastroenterol 2005;100:

Accuracy of Diagnostic Interpretation
4/6/2017 Accuracy of Diagnostic Interpretation Study Sensitivity (%) Specificity PPV NPV Pennazio et al. Gastrpenterology 2004 88.9 95 97 82.6 Delvaux et al. Endoscopy 2004 94.4 100 Saurin et al. Endoscopy 2005 92 48 Hartmann et al. GIE 2005 75 86 Hindryckx et al. ICCE 2006 95.2 98 96.1 97.6 Walsh et al. DDW 2006 87 87.9

Algorithm for CE in Obscure GI Bleeding
4/6/2017 Algorithm for CE in Obscure GI Bleeding Add algorithm OGIB Pennazio M, Eisen G, Goldfarb N. ICCE Consensus - Endoscopy 2005

“Missed Lesions” Detected by CE
4/6/2017 “Missed Lesions” Detected by CE Selby W. et al. GIE 2005;61(5): AB M1390 Chung H. et al. DDW 2006;63(4) Supp S: AB M1247 Edery J. et al. ICCE 2006;AB 7% to 25% of lesions detected by CE are NOT in the small bowel. Clinical significance unknown.

“Early CE” in Overt OGIB
4/6/2017 “Early CE” in Overt OGIB Ben Soussan et al. ICCE 2006;AB Gay G. et al. ICCE 2006;AB Yield of CE: 70-84% Timing of CE is important.

Patient Selection for CE in Obscure GI Bleeding
4/6/2017 Patient Selection for CE in Obscure GI Bleeding Patient selection for CE in OGIB is established in the literature; yet for IDA it is not. Clinical parameters to predict diagnostic yield not clearly established: transfusion requirements. May A. et al. J Clin Gastro 2005;39: Al Ali J. et al. Gastrointest Endosc 2006;63(4): AB M1346

Capsule Endoscopy and Double-balloon Enteroscopy
4/6/2017 Capsule Endoscopy and Double-balloon Enteroscopy “An initial diagnostic imaging employing CE might be followed by DBE for treatment or histopathological diagnosis.” Nakamura M, et al. Endoscopy 2006;38(1):59-66 Hadithi M, et al. Am J Gastro 2006;101:52-57 “The use of CE as a filter for DBE results in effective management of patients with various intestinal diseases. CE can also direct the choice of route of DBE.” Gay G, et al. Endoscopy 2006;38(1):49-58 Pennazio M. et al. DDW 2006;63(4) Supp S AB 496

Lai L, et al. Am J Gastro 2006;101:1224-1228
4/6/2017 Re-bleeding Rates in Patients with Positive and Negative CE 49 OGIB patients Yield of CE: 31 (63%) Interventions: 15 (30.6%) Mean follow-up: 19 m. Re-bleeding rate: 32.7% CE -: 5.6% CE +: 48.4% p=0.03 Lai L, et al. Am J Gastro 2006;101:

RR for bleeding relapse
4/6/2017 Longitudinal Prospective Cohort Study 285 OGIB patients Yield of CE: 177 (62%) – 50% underwent treatment Re-bleeding rate: 44 (18%) FACTOR RR for bleeding relapse Diagnosis “angioectasia” 6.64 Age >60 yrs. 2.87 Use of anticoagulants 2.65 Prior bleeding events 2.90 Negative CE 0.54 Albert JG, et al. DDW 2006;130(4): AB T1108

Repeating CE Bar-Meir S. et al. GIE 2004;60:711-13
4/6/2017 Repeating CE Bar-Meir S. et al. GIE 2004;60:711-13 Jones B.H. et al. Am J Gastro 2005;100:58-64 Dhaliwal H. et al. Gastrointest. Endosc. 2006;63(4) Supp S: AB M1247 Kimble JS. et al. Gastrointest. Endosc. 2006;63(4) Supp S:AB 497

Role of Repeat CE in Obscure GI Bleeding and IDA
4/6/2017 Role of Repeat CE in Obscure GI Bleeding and IDA Repeat upper endoscopy for OGIB has a 10-26% diagnostic yield. GI mucosal disease is a dynamic process and bleeding lesions may be present intermittently1. If initial study is non-diagnostic, repeat CE may increase diagnostic yield If initial CE study is technically inadequate (poor visualization, not reaching colon) repeat exam. Prospective comparative studies with other diagnostic modalities are needed. 1. Am J Gastroenterol 2005;100:

Impact of CE on Patient Management and Outcomes in Obscure GI Bleeding
4/6/2017 Impact of CE on Patient Management and Outcomes in Obscure GI Bleeding

Influence on clinical outcome
4/6/2017 Follow-up Studies Assessing the Influence on Clinical Outcome of Capsule Diagnosis in Patients with OGIB Study Year Pts (n) Yield of CE (%) Mean follow-up Influence on clinical outcome Pennazio et al. 2004 100 47 18a + Delvaux et al. 44 61 12 Carey et al. 260 58 6.7 Favre et al. 50 11 Chong et al. 75 69 4.7 Rastogi et al. 43 42 - De Leusse et al. 2005 64 45 13b Neu et al. 56 68 13 Walsh et al. 66 21 Kinzel et al. 74 De Looze et al. 53 Albert et al. 278 62 20c Viazis et al. 96 14d Saurin et al. 71 +/- Pennazio M. GIE Clin N Am 2006; 16:

4/6/2017 Major Management Changes and Outcomes in Relation to Diagnostic Findings PATIENTS WITH FINDINGS ON CAPSULE ENDOSCOPY n Management change No further bleeding Reduction of bleeding by > 50% Tumors, erosions, ulcers (due to Crohn's, NSAID, etc.) 11 9 (82%) 6 (55%) 7 (64%) Angiodysplasia, bleeding 27 8 (30%) 15 (56%) 21 (78%) Negative 18 4 (22%) 14 (78%) 16 (89%) ON OTHER TESTS 4 4 (100%) 2 (50%) 3 (75%) 17 7 (41%) 5 (29%) 12 (71%) 35 10 (29%) 28 (80%) 29 (83%) Major management and outcome changes were mainly in the groups with other than vascular lesions and of negative cases. Neu B, et al. Am J Gastro 2005;100: :

Impact of CE on Patient Management and Outcomes in Obscure GI Bleeding
4/6/2017 Impact of CE on Patient Management and Outcomes in Obscure GI Bleeding Published studies support a role for CE in directing patient management and improving outcomes. However, these studies lack standardized treatment protocols for findings at CE. Additional prospective studies are needed to better define the impact on patient outcomes in obscure GI bleeding. Outcomes to be measured: Bleeding resolution Transfusion requirements HLOS Patient satisfaction and HRQOL Resource utilization (e.g., additional diagnostic studies)

Role of CE in Iron Deficiency Anemia (IDA)
4/6/2017 Role of CE in Iron Deficiency Anemia (IDA) The World Health Organization estimates that approximately one-third of the population has IDA, yet it remains an under-managed complication of numerous gastrointestinal conditions*. Despite undergoing standard endoscopic evaluation of IDA with EGD and IC, up to 30% of patients with IDA remain without diagnosis. CE allows evaluation of the entire small bowel, is significantly more sensitive than radiographic examinations and standard endoscopy, and has been shown to have high diagnostic yields in patients with obscure GI bleeding and IDA*. Apostolopoulos P, Liatsos C, Gralnek IM, et al. “The Role of Wireless Capsule Endoscopy in Investigating Unexplained Iron Deficiency Anemia After Negative Endoscopic Evaluation of the Upper and Lower Gastrointestinal Tract.” Endoscopy 2006 (in Press); Isenberg G. et al. Gastrointest. Endos. 2006: 63(4);AB M1301 Milano A. et al. Gastrointest. Endos. 2006; 63(4):AB T1110

Iron Deficiency Anemia (IDA) Algorithm
4/6/2017 Iron Deficiency Anemia (IDA) Algorithm Unexplained IDA* [1,2] Ileocolonoscopy EGD + gastric + D2 biopsies** NEGATIVE Consider also: age, symptoms Video capsule endoscopy (VCE) Negative Positive Treat with Fe and observe for 3 months; Consider additional diagnostic studies (e.g., repeat VCE, push enteroscopy, ileocolonoscopy) if no improvement or recurrent IDA [3] Institute lesion-specific treatment for clinically significant findings*** *IDA proposed definition: Hgb < g/dl in women and < g/dl for men, MCV <76, ferritin <15 ug/dl. **Celiac serologies as clinically indicated. ***medical/surgical therapy, double-balloon enteroscopy, intraoperative enteroscopy. [1] Fireman et al. Digestive and Liver Diseases 2004;36: [2] Goddard et al. Gut 2000;46(suppl 4) 1-5. [3] Bar-Meir et al. Gastrointest Endosc 2004;60:

4/6/2017 Take-home Messages Capsule endoscopy should be performed early in the course of the work-up of patients with obscure bleeding and IDA (algorithms). Studies assessing the cost-effectiveness and budget impact of different approaches are needed. If initial study is non-diagnostic and bleeding continues, repeat CE may increase diagnostic yield; prospective comparative studies with other diagnostic modalities are needed. A second CE may prove of value if the lesion responsible for bleeding is bleeding intermittently or If the lesion was not seen on the initial exam (bowel unclean and obscures lesion). Jones H et al. Yield of Repeat Wireless Video Capsule Endoscopy in Patients with Obscure Gastrointestinal Bleeding. Am J. Gastroenterol 2005;100:

Tumors June 2006 Panel Co-Chairmen G. Gay W. Selby
4/6/2017 Tumors June 2006 Panel Co-Chairmen G. Gay W. Selby Panel Members: J.S. Barkin, E. Toth, S. Lo, C. Fraser, F. Hagenmueller, J.F. Rey

Small Bowel Tumors (SBT)
4/6/2017 Small Bowel Tumors (SBT) SB tumors account for: 3 - 6% of GI tumors 1 - 2% of GI malignancies Yearly Incidence USA 1-1.4/100,000 France Men: 0.5 – 1.3/100,000 Women: 0.8/100,000 Malignant tumors of small bowel have a poor prognosis Metastases 45% - 75% Unresectable 20% - 50% Survival rate 32.7% at 5 years

Clinical Presentation of SBT
4/6/2017 Clinical Presentation of SBT Two clinical pictures Intestinal obstruction Obscure digestive bleeding Often diagnosed late in course or incidentally at laparotomy or biopsy. At least 50% of benign lesions remain asymptomatic. Approximately 80% of malignant lesions produce symptoms. Symptoms or signs are not specific for either benign or malignant tumors. Presentation depends on the pathology of the neoplasm and location.

Morphological Investigations for Intestinal Tumors
4/6/2017 Morphological Investigations for Intestinal Tumors Radiology + Small bowel follow-through with enteroclysis Abdominal ultrasound ++ CT scanner / MRI +++ (if tumor > 1cm) CT scanner / MRI with enteroclysis Endoscopy Push enteroscopy +++ Intra-operative enteroscopy Ileo-colonoscopy Oesogastroduodenoscopy Video capsule endoscopy (VCE) Push and pull enteroscopy Nuclear Medicine Specific for neuroendocrine tumors Octreo-scan

SB Tumors and PillCam CE
4/6/2017 SB Tumors and PillCam CE Frequency of Intestinal Tumors detected by VCE % with Obscure Bleeding % Malignant Tumors Number of Tumors # Patients 79 % 53 % 50 (8.9%) 562 Corbin, 2004 70.8 % 61 % 48 (12.3%) 391 Delvaux, 2006 81 % 67 % 26 (6.3 %) 416 Bailey, 2006 100 % 11 (2.5 %)* 433 Urbain, 2006 The most common indication for PillCam endoscopy in patients with SBTs was obscure GI bleeding/anemia (80%). PillCam endoscopy detected SBTs after patients had undergone an average of 4.6 negative procedures *Malignant tumors only

SB Tumors and PillCam CE
4/6/2017 SB Tumors and PillCam CE 60% of SBT were malignant adenocarcinoma carcinoid melanoma lymphoma sarcoma, GIST 40% of SBT were benign GIST hemangioma hamartoma adenoma

4/6/2017 SB Tumor Consensus Can we predict an increased likelihood of SBT in a patient referred for VCE? presentation such as abdominal pain, weight loss, protein-losing enteropathy physical findings – mass, ascites, etc. episode of small bowel obstruction history of previous tumor The type of OGIB – occult or overt – is not helpful. Sensitivity of clinical signs for SB tumor is low.

Procedures available prior to VCE in patients with suspected SBT
4/6/2017 SB Tumor Consensus Procedures available prior to VCE in patients with suspected SBT No role for SB follow-through with or without enteroclysis CT ± enteroclysis MRI ± enteroclysis In the presence of obstructive signs can one predict the risk of retention? CT/MRI with enteroclysis Patency capsule

Role of VCE in diagnosing SB Tumours
4/6/2017 SB Tumor Consensus Role of VCE in diagnosing SB Tumours VCE > PE VCE ≈ PPE (DBE) Place of VCE in the diagnostic process Obscure GI bleeding Directly to VCE regardless of age Obstructive-type symptoms Consider PPE (DBE)

4/6/2017 SB Tumor Consensus Can we reliably determine criteria to indicate the presence of a mass lesion at endoscopy? mucosal disruption intact mucosa submucosal lesion extrinsic, e.g., intra-abdominal tumor false positive: is any bulging a mass? intussusceptions external compression by normal abdominal organ

SB Tumor Consensus What does a mass lesion found at VCE mean?
4/6/2017 SB Tumor Consensus What does a mass lesion found at VCE mean? Pancreatic rest GIST

4/6/2017 SB Tumor Consensus Can we predict histology/tumor type from VCE appearances? adenocarcinoma GIST pancreatic carcinoma

4/6/2017 SB Tumor Consensus Proposed score for probability of “mass” lesions seen at VCE MAJOR MINOR Bleeding Mucosal Irregular Polypoid Color Delayed White Invag- disruption surface appearance passage villi ination (≥ 30’) High Interme-diate +/ Low / These can be scored 3,2,1 to develop a tumor score.

SB Tumor Consensus High probability adenocarcinoma GIST adenocarcinoma
4/6/2017 SB Tumor Consensus High probability adenocarcinoma GIST adenocarcinoma B-cell lymphoma

4/6/2017 SB Tumor Consensus Intermediate probability adenoma GIST

SB Tumor Consensus Low probability
4/6/2017 SB Tumor Consensus Low probability Normal at intraoperative enteroscopy heterotopic gastric mucosa

SB Tumor Consensus Proposal of a practical approach
4/6/2017 SB Tumor Consensus Proposal of a practical approach Sequence of the procedures Procedures needed to make a decision Clinical relevance of the tumor score

SB Tumor Consensus High or Intermediate Probability of a Tumor
4/6/2017 SB Tumor Consensus “Mass” at VCE High or Intermediate Probability of a Tumor Cross-sectional imaging  enteroclysis to assess extraluminal disease PE/DBE Surgery

SB Tumor Consensus Low probability of a tumor “Mass” at VCE
4/6/2017 SB Tumor Consensus “Mass” at VCE Low probability of a tumor Cross-sectional imaging  enteroclysis Abnormal CT scan Normal CT scan High or Intermediate Significant clinical history No significant clinical history PE/DBE Surgery PE/DBE Repeat VCE

SB Tumor Consensus Key points of the consensus for diagnosis:
4/6/2017 SB Tumor Consensus Key points of the consensus for diagnosis: VCE leads to diagnosis of SB tumors earlier in their course. SB tumors detected with VCE are frequently revealed by OGIB, whereas previously, the most common presentation was obstruction and pain.

SB Tumor Consensus Key points of the consensus for treatment
4/6/2017 SB Tumor Consensus Key points of the consensus for treatment High or intermediate probability lesions may lead to DBE or surgery. The treatment of lesions with low probability will depend on their clinical significance.

SB Tumor Consensus Some unsolved issues
4/6/2017 SB Tumor Consensus Some unsolved issues Does VCE lead to improved outcome of SB tumors? Yes, if VCE leads to further diagnosis1 Outcome research essential Does VCE have a role in the follow-up and surveillance of treated SB tumors? Not used at present It may have a role – possibly depending on the histological type of tumor Need for further research 1. Bailey AA, Debinski H, Appleyard M, Remedios M, Hooper J, Walsh A, Selby WS. Diagnosis and outcome of small bowel tumors found by capsule endoscopy: a three-center Australian experience. Am J Gastroenterol 2006;101:In Press

SB Tumor Consensus Future directions
4/6/2017 SB Tumor Consensus Future directions Assessing outcomes after diagnosis of SB tumor by VCE Assessing outcomes for polyposis syndromes Predicting pathology and tumor type by VCE findings Evaluating the tumor scale Assessing size and location of lesions seen by VCE Improving visualization of duodenal/periampullary lesions Evaluating the role of VCE in specific tumors Attempting to reduce the rate of false negative VCE

Celiac Disease June 2006 Panel Co-Chairmen C. Cellier J. Murray
4/6/2017 Celiac Disease June 2006 Panel Co-Chairmen C. Cellier J. Murray Panel Members: P. Collin, G. Costamagna, P.H.R. Green, G.R. Corazza, E. Rondonotti, S. Schuppan, M. Willis

Panel Participants Christophe Cellier Consensus Co-chairmen
4/6/2017 Panel Participants Christophe Cellier Pekka Collin Peter Green Joe Murray Emanuele Rondonotti Moshe Rubin Detlef Schuppan Marsh Willis Consensus Co-chairmen Roberto de Franchis Blair Lewis Gèrard Gay

4/6/2017 Clinical Challenges Celiac disease is an immune-mediated disorder that primarily affects the GI tract. It is characterized by chronic inflammation of the small intestine mucosa that may result in atrophy of intestinal villi, malabsorption, and a variety of clinical manifestations, which may begin in either childhood or adult life. NIH Consensus 2004

Diagnosing Celiac Disease: “Tip of the Iceberg” Concept
4/6/2017 Diagnosing Celiac Disease: “Tip of the Iceberg” Concept Typical forms 1:2000 population Diarrhea Abdominal pain Weight loss/failure to thrive NIH Consensus 2004

Diagnosing Celiac Disease: “Tip of the Iceberg” Concept
4/6/2017 Atypical forms1% USA> 3 million population Europe > 2 million population Worldwide disease is more severe than previously indicated. Diabetes, Anemia, Osteoporosis, Irritable Bowel Syndrome, Malignant problems, Neurological problems, Behavioral changes Mäki et al, NEJM 2003 NIH Consensus 2004

Background: Diagnosis of Celiac Disease
4/6/2017 Background: Diagnosis of Celiac Disease Villous atrophy (duodenum) total/ subtotal partial increased number of IEL Circulating antibodies anti-endomysial IgA anti-transglutaminase IgA sensitivity/specificity > 95% Response (clinical /histological) to a GFD HLA DQ2 or DQ8: difficult case negative predictive value (99%) Consensus NIH 2004

Diagnosis of Celiac Disease
4/6/2017 Diagnosis of Celiac Disease Symptoms mimicking IBS (diarrhea, bloating, abdominal pain, etc.) Anemia (iron, folate, B12) Elevated transaminases Osteoporosis >60 years old (20%) <18 years old (4.6% to 17%) Consensus NIH 2004 De Franchis et al. Gastroenterology 2005;128;Supp 2:AB 548 Krauss et. al. Gastroenterology 2005;128:Supp 2:AB 547

Background: Treatment of Celiac Disease
4/6/2017 Background: Treatment of Celiac Disease Gluten free diet (wheat, rye, barley) Poor observance Malignant complications Osteopenia Auto-immune disorders Consensus NIH 2004

Background: Malignancy and Celiac Disease
4/6/2017 Background: Malignancy and Celiac Disease T- lymphoma:EATL In adults per million people, covers 35% of all small bowel lymphomas. Adenocarcinoma Occurs in per 100,000 general population;13% of these cases are associated with celiac disease. Clonal refractory sprue (CD3+/CD8-/CD103+): ulcerative jejunitis Alarm symptoms: obstruction, weight loss, bleeding,pain, fever

Current Data Highlights: Celiac Disease at diagnosis
4/6/2017 Current Data Highlights: Celiac Disease at diagnosis Capsule and diagnosis of CD de Franchis et al: ICCE2005: AB 015 Murray et al: Gastrointest Endosc 2003;58(1):92-95 Krauss et al: ICCE 2005:AB 049 n > 100 patients at diagnosis Comparison of capsule findings and histology: VCE equivalent to histology for the diagnosis of severe atrophy. More data required for patients with partial villous atrophy. Rondonotti et al :ICCE 2006;AB 20122

Current Data Highlights: Celiac Disease Diagnosis
4/6/2017 Current Data Highlights: Celiac Disease Diagnosis Mapping the extent of CD Murray et al Gastrointest Endosc 2004;59(4) AB459 Length of involvement: no correlation with GI symptoms, correlation with osteopenia Muhammad et al ICCE 2006 AB 20103 CD in duodenum and proximal intestine may be entirely normal while the distal intestine shows classic features of CD. Extent of CD can be estimated by CE which is not possible by other modalities. Patients with positive serology and negative histology Adler et al ICCE 2004 AB 1022 Patients with abdominal pain, positive celiac serology, and negative biopsy may still have organic disease in the SB.

Current Data Highlights: Complicated Celiac Disease
4/6/2017 Current Data Highlights: Complicated Celiac Disease Screening for complicated celiac disease Patients symptomatic on a GFD Daly et al Gastrointest Endosc 2004;59(5) AB 1806 (n= 47): villous atrophy: 68% ulcerations 50% cancer: 5% Krauss et al. Gastroenterol 2005;128(4) AB:547 (n=43) ulcerations: 25% tumours: 5%

Proposed Algorithm: Celiac Disease (CD) Diagnosis
4/6/2017 Proposed Algorithm: Celiac Disease (CD) Diagnosis CD diagnosis? tTG+ EMA+ tTG - EMA- IgA + ?stop/evaluate Duodenal biopsies Villous atrophy GFD Failure: CE Normal architecture CE?

Proposed Algorithm: Complicated Celiac Disease
4/6/2017 Proposed Algorithm: Complicated Celiac Disease Failure of GFD GFD observance yes No Dietician CE Negative Positive Observe VA to dietician and IEL phenotype Tumor or UJ to DBE

Consensus on Celiac Disease Symptomatic Treated CD
4/6/2017 Consensus on Celiac Disease Symptomatic Treated CD CE is frequently abnormal in symptomatic CD on a gluten free diet. Atrophy (60%) Ulcers common (20 -50%) significance (histological specimens) mostly in clonal refractory sprue (type II) Malignancies 2-10% lymphoma adenocarcinoma

4/6/2017 Defining “Atrophy” The presence of scalloping, fissuring, and mosaic patterns is characteristic of villous atrophy. The lack of visualization of normal villi in several successive folds alone might suggest CD. Minimal standard terminology and validation study needed.

Celiac Image Spectrum Absent Villi Fissuring Scalloping Scalloping
4/6/2017 Celiac Image Spectrum Absent Villi Fissuring Scalloping Scalloping Mosaic pattern Fissuring and ulcer

Celiac Consensus Conclusions
4/6/2017 Celiac Consensus Conclusions Indications for CE for the diagnosis of CD: High suspicion (tTg+, EmA+, or symptoms etc) in patients unwilling or unable to undergo upper GI endoscopy CE may be helpful when there is diagnostic difficulty such as: Sero + (EMA or tTG) with negative histology (patchy disease) Ambiguous histology and negative serology

Celiac Consensus Conclusions
4/6/2017 Celiac Consensus Conclusions Indications for CE in patients with known CD: For alarm symptoms in patients on a strict GFD (risk of malignancy) Weight loss Bleeding Anemia Pain Fever Recurrent malabsorption symptoms Abnormal imaging (except stricture)

Consensus on Celiac Disease: Diagnosis
4/6/2017 Consensus on Celiac Disease: Diagnosis Celiac disease should be considered in every CE examination for any reason (1% in general pop.). All CE endoscopists need to be able to recognize features of CD. Standard terminology and inter-observer agreement needed. There is supportive data for Positive Predictive Value. Need more data for Negative Predictive Value (partial villous atrophy).

Preps & Prokinetics Panel Co-Chairmen T Ponchon
4/6/2017 Preps & Prokinetics Panel Co-Chairmen K Mergener T Ponchon Panel Members: R. Enns, H. Nuutinen, B. Filoche, I. Schmelkin, D. DeMarco, W. Qureshi, D. Heresbach

Clinical Challenges Limitations of capsule endoscopy in some cases:
4/6/2017 Clinical Challenges Limitations of capsule endoscopy in some cases: Dark/opaque intestinal contents, bubbles, food/medication particles, fecal matter, impairing visualization of the mucosa

Clinical Challenges (continued)
4/6/2017 Clinical Challenges (continued) Limitations of capsule endoscopy in some cases: Slow gastric emptying and/or small bowel transit, leading to incomplete small bowel imaging in approximately 15-20% of cases

4/6/2017 ASGE CE SIG Survey Do you routinely use a laxative prior to SB capsule exams? Yes No

4/6/2017 ASGE CE SIG Survey If “yes”, which laxative do you use?

4/6/2017 ASGE CE SIG Survey Do you routinely use a prokinetic agent prior to SB CE? Yes No

4/6/2017 ASGE CE SIG Survey If “yes”, which type of prokinetic agent do you use?

4/6/2017 Definitions Bowel preparations: Medications given with the primary aim of cleansing the small bowel. Prokinetics: Medications given with the aim of accelerating gastric emptying and/or small bowel transit times, thus improving the proportion of cases in which the colon is reached.

Preps & Prokinetics 2006 Consensus Questions
4/6/2017 1. Has a scale been validated to evaluate SB cleanliness? 2. Do preps affect SB cleanliness? 3. Do preps affect the diagnostic yield of SB CE? 4. Do prokinetics affect (a) GTT, (b) SBTT, c) completeness of SB examination? 5. Do prokinetics affect the diagnostic yield of SB CE? 6. Are there unique side effects related to the use of preps and prokinetics? 7. Does the use of preps and prokinetics affect patient acceptance of SB CE?

General Comments – Limitations to the Consensus Review Process
4/6/2017 General Comments – Limitations to the Consensus Review Process Approximately 70 reports Few large randomized controlled trials Fewer peer-reviewed publications Many small retrospective series Publication bias Multiple studies from same institution Different types of agents, different administration schedules, combinations of agents, etc.

4/6/2017 Preps No validated scale is available (subjective global assessment vs. more precise analysis of individual frames) Total of 17 studies, 9 randomized Only 3 of 9 included more than 100 patients Only 1 of 9 published as peer-reviewed article

Preps – Recent Abstracts
4/6/2017 Preps – Recent Abstracts Pons et al., DDW 2006 Gastrointestinal Endosc 63(4): AB M1284: 291 patients (A) 4L clear liquids, (B) 90ml NaPhos, (C) 4L PEG NO SIGNIFICANT DIFFERENCES Lapalus et al., ICCE 2006:AB 123 patients (A) 12 hour fast, (B) 90ml NaPhos NO SIGNIFICANT DIFFERENCE Wi et al., Gastrointest Endosc 2006;63(4): AB M1310 125 patients (A) 12 hour fast, (B) 90ml NaPhos, (C) 2L PEG IMPROVED VISIBILITY AND IMPROVED DIAGNOSTIC YIELD WITH NaPHOS (BUT NOT WITH PEG)

Preps – Peer-reviewed Article
4/6/2017 Preps – Peer-reviewed Article Viazis et al. GIE 2004;60:534-8 Prospective, randomized, blinded 80 patients PEG 2L vs. clear liquids only Grading: “adequate” vs. “inadequate” Cleansing “adequate”: 36pts (90%) vs. 24pts (60%) Diagnosis established: 26pts (65%) vs. 12pts (30%)

Preps – Consensus Conclusions
4/6/2017 Preps – Consensus Conclusions Preps may not improve small-bowel cleanliness. No definitive evidence that preps increase diagnostic yield. No basis for recommending routine use in clinical practice. No negative impact on transit times demonstrated.

Prokinetics Prokinetics have been less well-studied.
4/6/2017 Prokinetics Prokinetics have been less well-studied. The clinically relevant endpoint of complete SB examination (vs. GTT/SBTT) has not been consistently reported. Tegaserod (6 studies, none fully published) is possibly effective for increasing the percentage of complete studies. The impact on diagnostic yield is unknown. Domperidone and metoclopramide have been less well studied with conflicting results. Erythromycin shortens GTT, but an effect on the rate of complete SB exams has not been demonstrated.

Positioning / Other Issues
4/6/2017 Positioning / Other Issues Right lateral decubitus position 3 abstracts, non-randomized Evaluation of GTT only Statistically significant difference in 1 of 3 studies Too few data to reach firm conclusion Predictive factors for incomplete SB exam Age, inpatient status and diabetes may be among the predictive factors of incomplete SB examination Not enough data to draw firm conclusions regarding the use of preps/prokinetics or postural maneuvers in these subgroups

Preps & Prokinetics 2006 Consensus Conclusions
4/6/2017 Preps & Prokinetics 2006 Consensus Conclusions 1. Has a scale been validated to evaluate SB cleanliness? No 2. Do preps affect SB cleanliness? Possibly No 3. Do preps affect the diagnostic yield of SB CE? Unknown 4. Do prokinetics affect (a) GTT, (b) SBTT, (c) completeness of SB examination? Yes (a) Possibly Yes (b/c) 5. Do prokinetics affect the diagnostic yield of SB CE? 6. Are there unique side effects related to the use of preps and prokinetics? 7. Does the use of preps and prokinetics affect patient acceptance of SB CE? Probably Yes

Conference Chairs Blair S. Lewis Roberto de Franchis Gèrard Gay

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