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

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Presentation on theme: "Consensus Report the 5 th International Conference on Capsule Endoscopy™ Conference Chairs Blair S. Lewis Roberto de Franchis Gèrard Gay."— Presentation transcript:

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

2 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

3 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

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

5 IBD Consensus Capsule Endoscopy (CE) for IBD:  Higher sensitivity for assessing small bowel mucosal lesions compared to other imaging techniques

6 Meta-analysis of Prospective Comparative Crohn’s Disease Studies: CE vs. Other Modalities Triester et al Am J Gastroenterol 2006;101: studies, n=223 Established or Suspected nPublished Study Established/Suspected 3 Costamagna 2002 Established 17Heigh 2003 Established/Suspected 19Bloom 2003 Established23Buchman 2003 Established 5Goelder 2003 Established 8Voderholzer 2003 Established/Suspected 21Chong 2003 Suspected35Eliakim 2004 Established/Suspected 47Toth 2004 Established/Suspected 31Dubcenco 2004 Established 19Marmo 2004

7 : CE vs. SB Radiography : 0.33 [-0.42, 1.09] 0.37 [0.08, 0.66] 0.48 [0.22, 0.73] 0.47 [0.17, 0.77] 0.00 [-0.27, 0.27] 0.61 [0.42, 0.81] 0.54 [0.35, 0.74] 0.53 [0.26, 0.80] 0.34 [0.17, 0.51] StudyIY (random)Incremental Yield (random) 95% CI Costamagna 2002 Bloom 2003 Chong 2003 Heigh 2003 Buchman 2004 Dubcenco 2004 Eliakim 2004 Marmo 2004 Toth 2004 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 < Higher yield SB radiography Higher yield CE Triester et al Am J Gastroenterol 2006;101:

8 CE vs. Ileoscopy Study IY (fixed) 95% CI Bloom [-0.26, 0.37] Heigh [-0.26, 0.37] Dubcenco [0.09, 0.55] Toth [-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 = Higher yield Ileoscopy Higher yield CE Triester et al Am J Gastroenterol 2006;101:

9 Study IY (fixed) 95% CI Heigh [-0.14, 0.50] Voderholzer [-0.42, 0.42] Eliakim [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 < Higher yield CTE Higher yield CE Triester et al. Am J Gastroenterol 2006;101: CE vs. CT Enterography (CTE)

10 Summary of Incremental Yield (IY) of CE Over Other Modalities Triester et al. Am J Gastroenterol 2006;101: % IY for CE (95% CI) Total yield other modality (%) Total yield CE (%) 42 ( )2466vs. SB Radiography 15 ( )4661vs. Ileoscopy 38 ( )3775vs. CT Enterography 44 ( )751vs. Push Enteroscopy 20 ( )4060vs. Small Bowel MRI

11 Suspected CD subgroup Study IY (random) [95% CI] Costamagna [-0.85, 0.85] Dubcenco [-0.04, 0.79] Eliakim [0.35, 0.74] Toth [-0.02, 0.37] Chong [-0.11, 0.11] Hara [-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 = Yield higher in barium radiography Yield higher in capsule endoscopy Study IY (random) [95% CI] Costamagna [-0.21, 1.21] Buchman [-0.20, 0.27] Dubcenco [0.49, 0.90] Marmo [0.23, 0.67] Toth [0.35, 0.87] Chong [0.38, 0.86] Hara [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 < Yield higher in barium radiography Yield higher in capsule endoscopy Established CD subgroup CE vs. Barium Radiography

12 CE vs. CT Enterography (n=58 pts) CE detects more proximal disease Voderholzer et al. Gut 2005;54: Hara et al. Radiology 2006;238(1): exams

13 MR Enteroclysis (n=18 pts) Golder et al. Int’l J of Colorectal Disease 2006;21(2): exams

14 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.

15 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

16  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 IBD Consensus

17 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

18 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 IBD Consensus

19 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. IBD Consensus

20 Capsule Endoscopy: Are All Ulcers Crohn’s? 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. ABC

21 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).

22 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

23 Example of Score Template Global Disease Assessment: Normal, Mild, Moderate/Severe

24 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

25 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. Suspected SB CD Positive ileocolonoscopy Negative ileocolonoscopy or unsuccessful Possible or known obstruction No obstruction Patency capsule CTE/MRE (SBFT) Capsule endoscopy Presence of SBCD Treat accordingly ObstructionNo obstruction either/or

26 Capsule Retention and CD TypeCapsule Retention (%) Patients (n)Author Type Known450Mow Suspected021Herrerias Suspected017Fireman Suspected020Eliakim Suspected520Sant’Anna Known6.730Buchman Known strictures13.038Chiefetz

27 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.

28 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.

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

30 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

31 Consensus Statement – Varices 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  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.

32 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

33 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

34 Comparison of PillCam ESO and EGD: Esophageal Varices NPVPPVSpecificitySensitivity Study Design # PatientsReference 57%100% 81%Prospective Blinded 21Study 1 74%94%87% Prospective Blinded 97Study 2 100%96%89%100%Prospective Blinded 32Study 3 1. Lapalus MG. Endoscopy 2006;38: Eisen GM, de Franchis R. Interim Analysis of the Evaluation of PillCam ESO in the Detection of Esophageal Varices AB 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

35 Esophageal Image Spectrum

36 Barrett’s Esophagus

37 Epidemiology in Barrett’s Esophagus times > general population up to 2% of patients with BE times > general population up to 2% of patients with BE Risk of esophageal cancer in Barrett’s esophagus 7% of US Population have daily GERD Symptoms 7% of US Population have daily GERD Symptoms 10% of Chronic GERD Patients have Barrett’s esophagus 10% of Chronic GERD Patients have Barrett’s esophagus Locke III et al. Gastro 1997: 112: Falk GW. Gastro Endosc 1999; 49(3):S29-34.

38 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).

39 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 Eliakim R et al. J Clin Gastroenterol 2005;39:

40 Patient Enrollment 1 unable to swallow capsule 93 (88%) endoscoped for GERD symptoms 13 (12%) for surveillance of Barrett’s esophagus 2 technical difficulties 109 patients enrolled 106 included in per-protocol statistical analysis Eliakim R et al. J Clin Gastroenterol 2005;39:

41 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. Eliakim R et al. J Clin Gastroenterol 2005;39:

42 Multi-center Study Results: Esophagitis EGD +- ECE ECE Sensitivity89% Specificity99% Positive Predictive Value (PPV)97% Negative Predictive Value (NPV)94% Eliakim R, Sharma VK et al. In press. J Clin Gastro Adjudicated results

43 Multi-center Results: Barrett’s Esophagus EGD +- ECE ECE Sensitivity97% Specificity99% Positive Predictive Value (PPV)97% Negative Predictive Value (NPV)99% Adjudicated results Eliakim R, Sharma VK et al. In press. J Clin Gastro

44 ECE Clinical Trials Barrett’s Esophagus Feasibility Trial3rd ESO Trial # of Patients1742 InvestigatorsEliakim, Yassin, Shlomi, Suissa, Eisen Koslowsky, Jacob, Eliakim, Adler Adjudication Panel no Sensitivity100% Specificity80%100% PublicationAPT 2004;20:1-7Endoscopy 2006;38 (1):27-30

45 ECE Clinical Trial Data: Barrett’s Esophagus NPVPPVSpecificitySensitivity# PatientsReference 89%56%84%67%58VA Mason Trial 1 74%86% 73%32Kansas 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

46 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.

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

48 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

49 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:

50 Value of CE for Obscure GI Bleeding Marmo et al. APT 2005;22:

51 Value of CE for Obscure GI Bleeding Triester et al. Am J Gastroenterol 2005;100:

52 Study Sensitivity (%) Specificity (%) PPV (%) NPV (%) Pennazio et al. Gastrpenterology Delvaux et al. Endoscopy Saurin et al. Endoscopy Hartmann et al. GIE Hindryckx et al. ICCE Walsh et al. DDW Accuracy of Diagnostic Interpretation

53 Algorithm for CE in Obscure GI Bleeding  Add algorithm OGIB Pennazio M, Eisen G, Goldfarb N. ICCE Consensus - Endoscopy 2005

54 “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 % to 25% of lesions detected by CE are NOT in the small bowel. Clinical significance unknown.

55 “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.

56 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

57 “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 Capsule Endoscopy and Double-balloon Enteroscopy

58 Lai L, et al. Am J Gastro 2006;101: 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 Re-bleeding Rates in Patients with Positive and Negative CE

59  285 OGIB patients  Yield of CE: 177 (62%) – 50% underwent treatment  Re-bleeding rate: 44 (18%) FACTORRR for bleeding relapse Diagnosis “angioectasia”6.64 Age >60 yrs.2.87 Use of anticoagulants2.65 Prior bleeding events2.90 Negative CE0.54 Albert JG, et al. DDW 2006;130(4): AB T1108 Longitudinal Prospective Cohort Study

60 Repeating CE  Bar-Meir S. et al. GIE 2004;60:  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

61 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 intermittently 1.  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:

62 Impact of CE on Patient Management and Outcomes in Obscure GI Bleeding

63 StudyYearPts (n) Yield of CE (%) Mean follow-up Influence on clinical outcome Pennazio et al a + Delvaux et al Carey et al Favre et al Chong et al Rastogi et al De Leusse et al b + Neu et al Walsh et al Kinzel et al De Looze et al Albert et al c + Viazis et al d + Saurin et al /- Pennazio M. GIE Clin N Am 2006; 16: Follow-up Studies Assessing the Influence on Clinical Outcome of Capsule Diagnosis in Patients with OGIB

64 PATIENTS WITH FINDINGS ON CAPSULE ENDOSCOPY nManagement change No further bleeding Reduction of bleeding by > 50% Tumors, erosions, ulcers (due to Crohn's, NSAID, etc.) 119 (82%)6 (55%)7 (64%) Angiodysplasia, bleeding278 (30%)15 (56%)21 (78%) Negative184 (22%)14 (78%)16 (89%) PATIENTS WITH FINDINGS ON OTHER TESTS nManagement change No further bleeding Reduction of bleeding by > 50% Tumors, erosions, ulcers (due to Crohn's, NSAID, etc.) 44 (100%)2 (50%)3 (75%) Angiodysplasia, bleeding177 (41%)5 (29%)12 (71%) Negative3510 (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: : Major Management Changes and Outcomes in Relation to Diagnostic Findings

65 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)

66 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

67 Iron Deficiency Anemia (IDA) Algorithm Unexplained IDA* [1,2] Ileocolonoscopy EGD + gastric + D2 biopsies** NEGATIVE Video capsule endoscopy (VCE) 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] Negative Institute lesion-specific treatment for clinically significant findings*** Positive *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: Consider also: age, symptoms

68 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:

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

70 Small Bowel Tumors (SBT)  SB tumors account for: 3 - 6% of GI tumors 1 - 2% of GI malignancies  Yearly Incidence  USA1-1.4/100,000  France  Men: 0.5 – 1.3/100,000  Women: 0.8/100,000  Malignant tumors of small bowel have a poor prognosis  Metastases45% - 75%  Unresectable20% - 50%  Survival rate32.7% at 5 years

71 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.

72 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 tumorsOctreo-scan

73 SB Tumors and PillCam CE  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 % with Obscure Bleeding % Malignant Tumors Number of Tumors # Patients 79 %53 %50 (8.9%)562Corbin, %61 %48 (12.3%)391Delvaux, %67 %26 (6.3 %)416Bailey, %11 (2.5 %)*433Urbain, 2006 Frequency of Intestinal Tumors detected by VCE *Malignant tumors only

74 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

75  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. SB Tumor Consensus

76  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 SB Tumor Consensus

77  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) SB Tumor Consensus

78  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

79 Pancreatic rest GIST What does a mass lesion found at VCE mean? SB Tumor Consensus

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

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

82 High probability adenocarcinomaGIST adenocarcinomaB-cell lymphoma SB Tumor Consensus

83 Intermediate probability adenoma GIST SB Tumor Consensus

84 Low probability heterotopic gastric mucosa Normal at intraoperative enteroscopy SB Tumor Consensus

85  Proposal of a practical approach  Sequence of the procedures  Procedures needed to make a decision  Clinical relevance of the tumor score SB Tumor Consensus

86 “Mass” at VCE High or Intermediate Probability of a Tumor Cross-sectional imaging  enteroclysis to assess extraluminal disease PE/DBESurgery SB Tumor Consensus

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

88  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

89  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

90  Some unsolved issues  Does VCE lead to improved outcome of SB tumors?  Yes, if VCE leads to further diagnosis 1  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

91  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 SB Tumor Consensus

92 Celiac Disease 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 June 2006

93 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

94 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

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

96 Diagnosing Celiac Disease: “Tip of the Iceberg” Concept 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

97 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

98 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

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

100 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

101 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

102 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  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.

103 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%

104 CD diagnosis? tTG+ EMA+ tTG - EMA- IgA + ?stop/evaluateDuodenal biopsies Villous atrophy GFD Failure: CE Normal architecture CE? Proposed Algorithm: Celiac Disease (CD) Diagnosis

105 Proposed Algorithm: Complicated Celiac Disease Failure of GFD GFD observance yesNo DieticianCE NegativePositive Observe VA to dietician and IEL phenotype Tumor or UJ to DBE

106 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

107 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.

108 Celiac Image Spectrum Absent Villi Fissuring Scalloping Mosaic patternFissuring and ulcerScalloping

109 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

110 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) Celiac Consensus Conclusions

111 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).

112 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

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

114 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 Clinical Challenges (continued)

115 ASGE CE SIG Survey Do you routinely use a laxative prior to SB capsule exams? YesNo

116 If “yes”, which laxative do you use? ASGE CE SIG Survey

117 Do you routinely use a prokinetic agent prior to SB CE? YesNo ASGE CE SIG Survey

118 If “yes”, which type of prokinetic agent do you use? ASGE CE SIG Survey

119 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.

120 Preps & Prokinetics 2006 Consensus Questions 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?

121 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.

122 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

123 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)

124 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%)

125 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.

126 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.

127 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

128 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? Unknown 6. Are there unique side effects related to the use of preps and prokinetics? No 7. Does the use of preps and prokinetics affect patient acceptance of SB CE? Probably Yes

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