Presentation on theme: "Conference Chairs Blair S. Lewis Roberto de Franchis Gèrard Gay"— Presentation transcript:
1 Conference Chairs Blair S. Lewis Roberto de Franchis Gèrard Gay 4/6/2017Consensus Report the 5th International Conference on Capsule Endoscopy™Conference ChairsBlair S. LewisRoberto de FranchisGèrard Gay
2 ICCE 2006 Two clinical congresses in 2006 Combined statistics 4/6/2017ICCE 2006Two clinical congresses in 2006Boca Raton, Florida, USAMarch 6-7, 2006Paris, FranceJune 9-10, 2006Combined statistics622 attendees40 countries represented146 abstracts presented89 oral presentations
3 4/6/2017Consensus ActivitiesReviewed last year’s data and updated ICCE 2005 ConsensusDrafted paper for peer-reviewed publication in Endoscopy this fallConsensus TopicsIBDEsophagusTumorsBleedingCeliacPreps/Prokinetics
4 Inflammatory Bowel Disease (IBD) 4/6/2017Inflammatory Bowel Disease (IBD)June 2006Panel Co-ChairmenE. SeidmanI. BjarnasonPanel Members: J. Leighton, P. Legnani, M. Gassull, J.F. Columbel, V. Manoury, A. Kornbluth
5 Capsule Endoscopy (CE) for IBD: 4/6/2017IBD ConsensusCapsule Endoscopy (CE) for IBD:Higher sensitivity for assessing small bowel mucosal lesions compared to other imaging techniques
6 Triester et al Am J Gastroenterol 2006;101:954-964 4/6/2017Meta-analysis of Prospective Comparative Crohn’s Disease Studies: CE vs. Other ModalitiesEstablished orSuspectednPublished StudyEstablished/Suspected3Costamagna 2002Established17Heigh 200319Bloom 200323Buchman 20035Goelder 20038Voderholzer 200321Chong 200335Eliakim 200447Toth 200431Dubcenco 2004Marmo 200411 studies, n=223Triester et al Am J Gastroenterol 2006;101:
7 Triester et al Am J Gastroenterol 2006;101:954-964 4/6/2017CE vs. SB Radiography::StudyIY (random)Incremental Yield (random)95% CI95% CICostamagna 20020.33 [-0.42, 1.09]Bloom 20030.37 [0.08, 0.66]Chong 20030.48 [0.22, 0.73]Heigh 20030.47 [0.17, 0.77]Buchman 20040.00 [-0.27, 0.27]Dubcenco 20040.61 [0.42, 0.81]Eliakim 20040.54 [0.35, 0.74]Marmo 20040.53 [0.26, 0.80]Toth 20040.34 [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 <-1-0.50.51Higher yield SB radiographyHigher yield CETriester et al Am J Gastroenterol 2006;101:
8 Triester et al Am J Gastroenterol 2006;101:954-964 4/6/2017CE vs. IleoscopyStudyIY (fixed)IY (fixed)95% CI95% CIBloom 20030.05 [-0.26, 0.37]Heigh 20030.06 [-0.26, 0.37]Dubcenco 20040.32 [0.09, 0.55]Toth 20040.11 [-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 = 0.02-1-0.50.51Higher yield IleoscopyHigher yield CETriester et al Am J Gastroenterol 2006;101:
9 CE vs. CT Enterography (CTE) 4/6/2017CE vs. CT Enterography (CTE)StudyIY (fixed)IY (fixed)95% CI95% CIHeigh 20030.18 [-0.14, 0.50]Voderholzer 20030.00 [-0.42, 0.42]Eliakim 20040.57 [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 <-1-0.50.51Higher yield CTEHigher yield CETriester et al. Am J Gastroenterol 2006;101:
10 Summary of Incremental Yield (IY) of CE Over Other Modalities 4/6/2017% IY for CE (95% CI)Total yield other modality (%)Total yieldCE (%)42 ( )2466vs. SB Radiography15 ( )4661vs. Ileoscopy38 ( )3775vs. CT Enterography44 ( )751vs. Push Enteroscopy20 ( )4060vs. Small Bowel MRITriester et al. Am J Gastroenterol 2006;101:
11 CE vs. Barium Radiography 4/6/2017CE vs. Barium RadiographySuspected CD subgroupStudyIY (random) [95% CI]IY (random) [95% CI]Costamagna 20020.00 [-0.85, 0.85]Dubcenco 20040.38 [-0.04, 0.79]Eliakim 20040.54 [0.35, 0.74]Toth 20040.17 [-0.02, 0.37]Chong 20050.00 [-0.11, 0.11]Hara 20050.25 [-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 = 0.09-1-0.50.51Yield higher in barium radiographyYield higher in capsule endoscopyEstablished CD subgroupStudyIY (random) [95% CI]IY (random) [95% CI]Costamagna 20020.50 [-0.21, 1.21]Buchman 20040.03 [-0.20, 0.27]Dubcenco 20040.70 [0.49, 0.90]Marmo 20040.45 [0.23, 0.67]Toth 20040.61 [0.35, 0.87]Chong 20050.62 [0.38, 0.86]Hara 20050.67 [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 < 0.001-1-0.50.51Yield higher in barium radiographyYield higher in capsule endoscopy
12 CE vs. CT Enterography (n=58 pts) CE detects more proximal disease 4/6/2017CE vs. CT Enterography (n=58 pts) CE detects more proximal disease+ examsIn 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):
13 MR Enteroclysis (n=18 pts) 4/6/2017MR Enteroclysis (n=18 pts)+ examsMR 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
14 Capsule endoscopy (CE) vs. other imaging: 4/6/2017IBD ConsensusCapsule endoscopy (CE) vs. other imaging:LimitationsThe 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 Mascarenhas-Saraiva M, et al. ICCE 2005 AB 115 4/6/2017IBD ConsensusCE may be useful in the study of indeterminate colitis:22 pts with colonic IBD underwent CE.9 (40%) with “colitis” were found to have smallbowel 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;2:31-40Mascarenhas-Saraiva M, et al. ICCE 2005 AB 115Hume G, et al. ICCE 2004 AB 1054
16 IBD Consensus 31 patients with IC and known serology 4/6/2017IBD Consensus31 patients with IC and known serologyCE 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
17 Role of CE in assessing for early post- operative recurrence 4/6/2017IBD ConsensusRole of CE in assessing for early post-operative recurrence32 post-op ileocecal resectionCE & ileo-colonoscopy < 6 monthsRecurrence: 21/32 – sensitivityIleo-colonoscopy 90% vs. 62% for CECE 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:
18 IBD Consensus Role of CE in assessing for early 4/6/2017IBD ConsensusRole of CE in assessing for earlypost-operative recurrence14 patients post-op ileocecal resection x 1 yrCE & small bowel US compared in 13 (1 stricture)Recurrence: 12/13 by colonoscopyUS: 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
19 Capsule endoscopy (CE) for suspected IBD: 4/6/2017IBD ConsensusCapsule endoscopy (CE) for suspected IBD:Useful and safe in patients with suspected Crohn’s disease and negative endoscopic & small bowel imagingEvidence: 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.
20 Capsule Endoscopy: Are All Ulcers Crohn’s? 4/6/2017Capsule Endoscopy: Are All Ulcers Crohn’s?ABCWhich 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.
21 4/6/2017IBD ConsensusStandardized 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 Scale Villous Appearance Ulceration Stenosis 4/6/2017Scoring IndexParametersVillous AppearanceUlcerationStenosisScaleNormal, edematousNumber - single, few, multipleDistribution - localized, patchy, diffuseLongitudinal extent - short, long, whole segmentUlcer size - based on amount of bowel wall circumference involvedStenosis - ulcerated or not, traversed or not
23 Example of Score Template 4/6/2017Example of Score TemplateGlobal Disease Assessment: Normal, Mild, Moderate/Severe
24 Suspected Crohn’s Disease 4/6/2017Suspected Crohn’s DiseasePatients 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 painChronic diarrheaSignificant weight lossGrowth failureExtra-intestinal SymptomsUnexplained recurrent feverArthritis/arthralgiasPyoderma/erythema nodosumAphthous stomatitisPerianal diseasePSC/recurrent cholangitisInflammatory MarkersIron deficiency anemiaThrombocytosis or leukocytosisElevated ESR or CRPHypoalbuminemiaPositive IBD serologyFecal markers: lactoferrin, alpha-1 antitrypsin, calprotectin; heme +; leucocyte +Abnormal, Non-diagnostic Imaging
25 Negative ileocolonoscopy 4/6/2017Suspected SB CDPositiveileocolonoscopyNegative ileocolonoscopyor unsuccessfulNoobstructionPossible or knownobstructionPatencycapsuleeither/orNo obstructionObstructionCapsule endoscopyCTE/MRE(SBFT)Presence of SBCDTreat accordinglyFigure 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.
26 Capsule Retention and CD 4/6/2017Capsule Retention and CDTypeCapsule Retention (%)Patients (n)Author TypeKnown450MowSuspected21Herrerias17Fireman20Eliakim5Sant’Anna6.730BuchmanKnown strictures13.038Chiefetz
27 Capsule Retention in Crohn’s Disease 4/6/2017Capsule Retention in Crohn’s DiseaseIn 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 4/6/2017ConclusionsCE 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 June 2006 Panel Co-Chairmen R. Eliakim G. Eisen 4/6/2017EsophagusJune 2006Panel Co-ChairmenR. EliakimG. EisenPanel Members: J.P. Galmiche, T. Roesch, F. Schnoll-Sussman, J. Herrerias, V.K. Sharma, E. Coron
30 Consensus Statement - Esophageal Capsule Endoscopy (ECE) 4/6/2017Consensus Statement - Esophageal Capsule Endoscopy (ECE)A new approach to esophageal diagnosticsSimple and easyPatient-friendlyScreening tool for esophageal diseasesEncouraging initial clinical dataEsophageal VaricesBarrett’s Esophagus
31 Consensus Statement – Varices 4/6/2017Consensus Statement – VaricesEsophageal 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
32 Consensus Statement – Varices (continued) 4/6/2017Consensus Statement – Varices (continued)Recommended endoscopic screening intervals are1-3 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 4/6/2017EV Screening Pilot TrialInitial pilot trial – EV screening with ESOProspective blinded, 3 center study32 patients – enriched population with surveillanceNo complications, no retentionJapanese endoscopic grading systemF0 = noneF1 = smallF2 = mediumF3 = largeModified classification for current trialNone/small/medium-largeMedium-Large > 25% circumferenceEisen 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 4/6/2017Comparison of PillCam ESO and EGD: Esophageal VaricesNPVPPVSpecificitySensitivityStudyDesign# PatientsReference57%100%81%Prospective Blinded21Study 174%94%87%97Study 296%89%32Study 31.Lapalus MG. Endoscopy 2006;38:36-42. Eisen GM, de Franchis R. Interim Analysis of the Evaluation of PillCam ESO in the Detection of Esophageal Varices AB 201543.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
36 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.
37 Epidemiology in Barrett’s Esophagus 4/6/2017Epidemiology in Barrett’s Esophagus7% of US Population havedaily GERD Symptoms10% of Chronic GERD Patientshave Barrett’s esophagusNotes: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):SRisk of esophageal cancer in Barrett’s esophagus30-60 times > general populationup to 2% of patients with BELocke III et al. Gastro 1997: 112:Falk GW. Gastro Endosc 1999; 49(3):S29-34.
38 Screening for Barrett’s Esophagus 4/6/2017Screening for Barrett’s EsophagusAdenocarcinoma 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 4/6/2017Multi-center Study OverviewPrimary aimsAccuracy of ECE compared with EGD for the diagnosis of esophageal pathology in patients with chronic GERD symptomsSpecificity, sensitivity, PPV, NPVSafety and adverse events of ECESecondary aimsAssess capability of ECE to identify presence of Barrett’s esophagus in patients undergoing surveillance endoscopyAssess patient satisfaction with both proceduresMulti-site: Prospective 7-center international studyIsrael (3), USA (3), Germany (1)Inclusion criteriaAged 18 years or olderConfirmation of 1 of the following:Histologic confirmation of Barrett's esophagus undergoing surveillance endoscopyChronic GERD symptoms undergoing upper endoscopy for the evaluation of GERDThe authors hypothesized that in patients with GERD, esophageal imaging with ECE would be as accurate as conventional upper endoscopy in detecting esophageal pathologySeven medical centers enrolled patients into this studyEnrollment into the study was based on the following inclusion criteria:Patients who were aged 18 years or olderPatients 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 GERDPatients who were able to give consentPatients who were eligible and willing to undergo upper endoscopyPatients who had no contraindications to ECEReferenceEliakim 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:
40 Patient Enrollment 109 patients enrolled 1 unable to swallow capsule 4/6/2017Patient Enrollment109 patients enrolled1 unable to swallow capsule2 technical difficulties106 included in per-protocol statistical analysisOne 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.ReferenceEliakim 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 symptoms13 (12%) for surveillance of Barrett’s esophagusEliakim R et al. J Clin Gastroenterol 2005;39:
41 Methods ECE swallowed using standardized ingestion protocol. 4/6/2017MethodsECE 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 protocolAn investigator, blinded to the patient’s history and the diagnostic findings of the upper endoscopy, reviewed the ECE videos and documented the findingsUpper endoscopy was performed on the same day following the ECEAll 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 indicatedOne week following the ECE, the patients were contacted to confirm excretion of capsule and to document any study-related adverse eventsAn 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 resultsReferenceEliakim 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:
42 Multi-center Study Results: Esophagitis 4/6/2017Multi-center Study Results: EsophagitisEGD+-ECE331468Sensitivity89%Specificity99%Positive Predictive Value (PPV)97%Negative Predictive Value (NPV)94%Adjudicated resultsEliakim R, Sharma VK et al. In press. J Clin Gastro
43 Multi-center Results: Barrett’s Esophagus 4/6/2017Multi-center Results: Barrett’s EsophagusEGD+-ECE32172Sensitivity97%Specificity99%Positive Predictive Value (PPV)Negative Predictive Value (NPV)Adjudicated resultsEliakim R, Sharma VK et al. In press. J Clin Gastro
45 ECE Clinical Trial Data: Barrett’s Esophagus 4/6/2017ECE Clinical Trial Data: Barrett’s EsophagusNPVPPVSpecificitySensitivity# PatientsReference89%56%84%67%58VA Mason Trial 174%86%73%32Kansas Trial 21.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 4/6/2017ConclusionsECE 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 June 2006 Panel Co-Chairmen M. Pennazio I. Gralnek 4/6/2017GI BleedingJune 2006Panel Co-ChairmenM. PennazioI. GralnekPanel Members: M. Delvaux, N. Reddy S. Bar Meir, I. Demedts, M. Keuchel
49 Value of CE for Obscure GI Bleeding 4/6/2017Value of CE for Obscure GI BleedingCE 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 4/6/2017Value of CE for Obscure GI BleedingMarmo et al. APT 2005;22:
51 Value of CE for Obscure GI Bleeding 4/6/2017Value of CE for Obscure GI BleedingTriester et al. Am J Gastroenterol 2005;100:
52 Accuracy of Diagnostic Interpretation 4/6/2017Accuracy of Diagnostic InterpretationStudySensitivity(%)SpecificityPPVNPVPennazio et al.Gastrpenterology 200488.9959782.6Delvaux et al.Endoscopy 200494.4100Saurin et al.Endoscopy 20059248Hartmann et al.GIE 20057586Hindryckx et al.ICCE 200695.29896.197.6Walsh et al.DDW 20068787.9
53 Algorithm for CE in Obscure GI Bleeding 4/6/2017Algorithm for CE in Obscure GI BleedingAdd algorithm OGIBPennazio M, Eisen G, Goldfarb N.ICCE Consensus - Endoscopy 2005
54 “Missed Lesions” Detected by CE 4/6/2017“Missed Lesions” Detected by CESelby W. et al. GIE 2005;61(5): AB M1390Chung H. et al. DDW 2006;63(4) Supp S: AB M1247Edery J. et al. ICCE 2006;AB7% to 25% of lesions detected by CEare NOT in the small bowel.Clinical significance unknown.
55 “Early CE” in Overt OGIB 4/6/2017“Early CE” in Overt OGIBBen Soussan et al. ICCE 2006;ABGay G. et al. ICCE 2006;ABYield of CE: 70-84%Timing of CE is important.
56 Patient Selection for CE in Obscure GI Bleeding 4/6/2017Patient Selection for CE in Obscure GI BleedingPatient 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 Capsule Endoscopy and Double-balloon Enteroscopy 4/6/2017Capsule 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):59-66Hadithi M, et al. Am J Gastro 2006;101:52-57“The use of CE as a filter for DBE results in effectivemanagement of patients with various intestinal diseases.CE can also direct the choice of route of DBE.”Gay G, et al. Endoscopy 2006;38(1):49-58Pennazio M. et al. DDW 2006;63(4) Supp S AB 496
58 Lai L, et al. Am J Gastro 2006;101:1224-1228 4/6/2017Re-bleeding Rates in Patients with Positive and Negative CE49 OGIB patientsYield 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=0.03Lai L, et al. Am J Gastro 2006;101:
59 RR for bleeding relapse 4/6/2017Longitudinal ProspectiveCohort Study285 OGIB patientsYield of CE: 177 (62%) – 50% underwent treatmentRe-bleeding rate: 44 (18%)FACTORRR for bleeding relapseDiagnosis “angioectasia”6.64Age >60 yrs.2.87Use of anticoagulants2.65Prior bleeding events2.90Negative CE0.54Albert JG, et al. DDW 2006;130(4): AB T1108
60 Repeating CE Bar-Meir S. et al. GIE 2004;60:711-13 4/6/2017Repeating CEBar-Meir S. et al. GIE 2004;60:711-13Jones B.H. et al. Am J Gastro 2005;100:58-64Dhaliwal H. et al. Gastrointest. Endosc. 2006;63(4) Supp S: AB M1247Kimble JS. et al. Gastrointest. Endosc. 2006;63(4) Supp S:AB 497
61 Role of Repeat CE in Obscure GI Bleeding and IDA 4/6/2017Role of Repeat CE in Obscure GI Bleeding and IDARepeat 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 yieldIf 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 4/6/2017Impact of CE on Patient Management and Outcomes in Obscure GI Bleeding
63 Influence on clinical outcome 4/6/2017Follow-up Studies Assessing the Influence on Clinical Outcome of Capsule Diagnosis in Patients with OGIBStudyYearPts(n)Yield of CE(%)Meanfollow-upInfluence on clinical outcomePennazio et al.20041004718a+Delvaux et al.446112Carey et al.260586.7Favre et al.5011Chong et al.75694.7Rastogi et al.4342-De Leusse et al.2005644513bNeu et al.566813Walsh et al.6621Kinzel et al.74De Looze et al.53Albert et al.2786220cViazis et al.9614dSaurin et al.71+/-Pennazio M. GIE Clin N Am 2006; 16:
64 4/6/2017Major Management Changes and Outcomes in Relation to Diagnostic FindingsPATIENTS WITH FINDINGSON CAPSULE ENDOSCOPYnManagementchangeNo furtherbleedingReduction ofbleeding 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%)ON OTHER TESTS44 (100%)2 (50%)3 (75%)177 (41%)5 (29%)12 (71%)3510 (29%)28 (80%)29 (83%)Major management and outcome changes were mainlyin the groups with other than vascular lesions and of negative cases.Neu B, et al. Am J Gastro 2005;100: :
65 Impact of CE on Patient Management and Outcomes in Obscure GI Bleeding 4/6/2017Impact of CE on Patient Management and Outcomes in Obscure GI BleedingPublished 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 resolutionTransfusion requirementsHLOSPatient satisfaction and HRQOLResource utilization (e.g., additional diagnostic studies)
66 Role of CE in Iron Deficiency Anemia (IDA) 4/6/2017Role 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 M1301Milano A. et al. Gastrointest. Endos. 2006; 63(4):AB T1110
67 Iron Deficiency Anemia (IDA) Algorithm 4/6/2017Iron Deficiency Anemia (IDA) AlgorithmUnexplained IDA* [1,2]IleocolonoscopyEGD + gastric + D2 biopsies**NEGATIVEConsider also:age, symptomsVideo capsule endoscopy (VCE)NegativePositiveTreat with Fe and observe for 3 months; Consideradditional diagnostic studies (e.g., repeat VCE, push enteroscopy,ileocolonoscopy) if no improvement or recurrent IDA Institute lesion-specific treatmentfor 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. Fireman et al. Digestive and Liver Diseases 2004;36: Goddard et al. Gut 2000;46(suppl 4) 1-5. Bar-Meir et al. Gastrointest Endosc 2004;60:
68 4/6/2017Take-home MessagesCapsule 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 orIf 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 June 2006 Panel Co-Chairmen G. Gay W. Selby 4/6/2017TumorsJune 2006Panel Co-ChairmenG. GayW. SelbyPanel Members: J.S. Barkin, E. Toth, S. Lo, C. Fraser, F. Hagenmueller, J.F. Rey
70 Small Bowel Tumors (SBT) 4/6/2017Small Bowel Tumors (SBT)SB tumors account for: 3 - 6% of GI tumors1 - 2% of GI malignanciesYearly IncidenceUSA 1-1.4/100,000FranceMen: 0.5 – 1.3/100,000Women: 0.8/100,000Malignant tumors of small bowel have a poor prognosisMetastases 45% - 75%Unresectable 20% - 50%Survival rate 32.7% at 5 years
71 Clinical Presentation of SBT 4/6/2017Clinical Presentation of SBTTwo clinical picturesIntestinal obstructionObscure digestive bleedingOften 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 4/6/2017Morphological Investigations for Intestinal TumorsRadiology+Small bowel follow-through with enteroclysisAbdominal ultrasound++CT scanner / MRI+++ (if tumor > 1cm)CT scanner / MRI with enteroclysisEndoscopyPush enteroscopy+++Intra-operative enteroscopyIleo-colonoscopyOesogastroduodenoscopyVideo capsule endoscopy (VCE)Push and pull enteroscopyNuclear MedicineSpecific for neuroendocrine tumorsOctreo-scan
73 SB Tumors and PillCam CE 4/6/2017SB Tumors and PillCam CEFrequency of Intestinal Tumors detected by VCE% with Obscure Bleeding% Malignant TumorsNumber of Tumors# Patients79 %53 %50 (8.9%)562Corbin, 200470.8 %61 %48 (12.3%)391Delvaux, 200681 %67 %26 (6.3 %)416Bailey, 2006100 %11 (2.5 %)*433Urbain, 2006The 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
74 SB Tumors and PillCam CE 4/6/2017SB Tumors and PillCam CE60% of SBT were malignantadenocarcinomacarcinoidmelanomalymphomasarcoma, GIST40% of SBT were benignGISThemangiomahamartomaadenoma
75 4/6/2017SB Tumor ConsensusCan we predict an increased likelihood of SBT in a patient referred for VCE?presentation such as abdominal pain, weight loss, protein-losing enteropathyphysical findings – mass, ascites, etc.episode of small bowel obstructionhistory of previous tumorThe type of OGIB – occult or overt – is not helpful.Sensitivity of clinical signs for SB tumor is low.
76 Procedures available prior to VCE in patients with suspected SBT 4/6/2017SB Tumor ConsensusProcedures available prior to VCE in patients with suspected SBTNo role for SB follow-through with or without enteroclysisCT ± enteroclysisMRI ± enteroclysisIn the presence of obstructive signs can one predict the risk of retention?CT/MRI with enteroclysisPatency capsule
77 Role of VCE in diagnosing SB Tumours 4/6/2017SB Tumor ConsensusRole of VCE in diagnosing SB TumoursVCE > PEVCE ≈ PPE (DBE)Place of VCE in the diagnostic processObscure GI bleedingDirectly to VCE regardless of ageObstructive-type symptomsConsider PPE (DBE)
78 4/6/2017SB Tumor ConsensusCan we reliably determine criteria to indicate the presence of a mass lesion at endoscopy?mucosal disruptionintact mucosasubmucosal lesionextrinsic, e.g., intra-abdominal tumorfalse positive: is any bulging a mass?intussusceptionsexternal compression by normal abdominal organ
79 SB Tumor Consensus What does a mass lesion found at VCE mean? 4/6/2017SB Tumor ConsensusWhat does a mass lesion found at VCE mean?Pancreatic restGIST
80 4/6/2017SB Tumor ConsensusCan we predict histology/tumor type from VCE appearances?adenocarcinomaGISTpancreatic carcinoma
81 4/6/2017SB Tumor ConsensusProposed score for probability of “mass” lesions seen at VCEMAJORMINORBleeding Mucosal Irregular Polypoid Color Delayed White Invag-disruption surface appearance passage villi ination(≥ 30’)HighInterme-diate+/Low/These can be scored 3,2,1 to develop a tumor score.
82 SB Tumor Consensus High probability adenocarcinoma GIST adenocarcinoma 4/6/2017SB Tumor ConsensusHigh probabilityadenocarcinomaGISTadenocarcinomaB-cell lymphoma
84 SB Tumor Consensus Low probability 4/6/2017SB Tumor ConsensusLow probabilityNormal at intraoperative enteroscopyheterotopic gastric mucosa
85 SB Tumor Consensus Proposal of a practical approach 4/6/2017SB Tumor ConsensusProposal of a practical approachSequence of the proceduresProcedures needed to make a decisionClinical relevance of the tumor score
86 SB Tumor Consensus High or Intermediate Probability of a Tumor 4/6/2017SB Tumor Consensus“Mass” at VCEHigh or Intermediate Probability of a TumorCross-sectional imaging enteroclysis to assess extraluminal diseasePE/DBESurgery
87 SB Tumor Consensus Low probability of a tumor “Mass” at VCE 4/6/2017SB Tumor Consensus“Mass” at VCELow probability of a tumorCross-sectional imaging enteroclysisAbnormal CT scanNormal CT scanHigh or IntermediateSignificantclinical historyNo significantclinical historyPE/DBESurgeryPE/DBERepeatVCE
88 SB Tumor Consensus Key points of the consensus for diagnosis: 4/6/2017SB Tumor ConsensusKey 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.
89 SB Tumor Consensus Key points of the consensus for treatment 4/6/2017SB Tumor ConsensusKey points of the consensus for treatmentHigh or intermediate probability lesions may lead to DBE or surgery.The treatment of lesions with low probability will depend on their clinical significance.
90 SB Tumor Consensus Some unsolved issues 4/6/2017SB Tumor ConsensusSome unsolved issuesDoes VCE lead to improved outcome of SB tumors?Yes, if VCE leads to further diagnosis1Outcome research essentialDoes VCE have a role in the follow-up and surveillance of treated SB tumors?Not used at presentIt may have a role – possibly depending on the histological type of tumorNeed for further research1. 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
91 SB Tumor Consensus Future directions 4/6/2017SB Tumor ConsensusFuture directionsAssessing outcomes after diagnosis of SB tumor by VCEAssessing outcomes for polyposis syndromesPredicting pathology and tumor type by VCE findingsEvaluating the tumor scaleAssessing size and location of lesions seen by VCEImproving visualization of duodenal/periampullary lesionsEvaluating the role of VCE in specific tumorsAttempting to reduce the rate of false negative VCE
92 Celiac Disease June 2006 Panel Co-Chairmen C. Cellier J. Murray 4/6/2017Celiac DiseaseJune 2006Panel Co-ChairmenC. CellierJ. MurrayPanel Members: P. Collin, G. Costamagna, P.H.R. Green, G.R. Corazza, E. Rondonotti, S. Schuppan, M. Willis
94 4/6/2017Clinical ChallengesCeliac 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 4/6/2017Diagnosing Celiac Disease: “Tip of the Iceberg” ConceptTypical forms 1:2000 populationDiarrheaAbdominal painWeight loss/failure to thriveNIH Consensus 2004
96 Diagnosing Celiac Disease: “Tip of the Iceberg” Concept 4/6/2017Atypical forms1%USA> 3 million populationEurope > 2 million populationWorldwide disease is more severe than previously indicated.Diabetes, Anemia, Osteoporosis, Irritable Bowel Syndrome, Malignant problems, Neurological problems, Behavioral changesMäki et al, NEJM 2003NIH Consensus 2004
97 Background: Diagnosis of Celiac Disease 4/6/2017Background: Diagnosis of Celiac DiseaseVillous atrophy (duodenum)total/ subtotalpartialincreased number of IELCirculating antibodiesanti-endomysial IgAanti-transglutaminase IgAsensitivity/specificity > 95%Response (clinical /histological) to a GFDHLA DQ2 or DQ8: difficult casenegative predictive value (99%)Consensus NIH 2004
98 Diagnosis of Celiac Disease 4/6/2017Diagnosis of Celiac DiseaseSymptoms mimicking IBS (diarrhea, bloating, abdominal pain, etc.)Anemia (iron, folate, B12)Elevated transaminasesOsteoporosis>60 years old (20%)<18 years old (4.6% to 17%)Consensus NIH 2004De Franchis et al. Gastroenterology 2005;128;Supp 2:AB 548Krauss et. al. Gastroenterology 2005;128:Supp 2:AB 547
100 Background: Malignancy and Celiac Disease 4/6/2017Background: Malignancy and Celiac DiseaseT- lymphoma:EATLIn adults per million people, covers 35% of all small bowel lymphomas.AdenocarcinomaOccurs in per 100,000 general population;13% of these cases are associated with celiac disease.Clonal refractory sprue (CD3+/CD8-/CD103+):ulcerative jejunitisAlarm symptoms: obstruction, weight loss, bleeding,pain, fever
101 Current Data Highlights: Celiac Disease at diagnosis 4/6/2017Current Data Highlights: Celiac Disease at diagnosisCapsule and diagnosis of CDde Franchis et al: ICCE2005: AB 015Murray et al: Gastrointest Endosc 2003;58(1):92-95Krauss et al: ICCE 2005:AB 049n > 100 patients at diagnosisComparison 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 4/6/2017Current Data Highlights: Celiac Disease DiagnosisMapping the extent of CDMurray et al Gastrointest Endosc 2004;59(4) AB459Length of involvement: no correlation with GI symptoms,correlation with osteopeniaMuhammad et al ICCE 2006 AB 20103CD 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 histologyAdler et al ICCE 2004 AB 1022Patients with abdominal pain, positive celiac serology, and negative biopsy may still have organic disease in the SB.
103 Current Data Highlights: Complicated Celiac Disease 4/6/2017Current Data Highlights: Complicated Celiac DiseaseScreening for complicated celiac diseasePatients symptomatic on a GFDDaly 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%
105 Proposed Algorithm: Complicated Celiac Disease 4/6/2017Proposed Algorithm: Complicated Celiac DiseaseFailure of GFDGFD observanceyesNoDieticianCENegativePositiveObserveVA to dietician andIEL phenotypeTumor or UJ to DBE
106 Consensus on Celiac Disease Symptomatic Treated CD 4/6/2017Consensus on Celiac Disease Symptomatic Treated CDCE 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%lymphomaadenocarcinoma
107 4/6/2017Defining “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.
109 Celiac Consensus Conclusions 4/6/2017Celiac Consensus ConclusionsIndications for CE for the diagnosis ofCD:High suspicion (tTg+, EmA+, or symptoms etc) in patients unwilling or unable to undergo upper GI endoscopyCE 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 Celiac Consensus Conclusions 4/6/2017Celiac Consensus ConclusionsIndications for CE in patientswith known CD:For alarm symptoms in patients on a strict GFD (risk of malignancy)Weight lossBleedingAnemiaPainFeverRecurrent malabsorption symptomsAbnormal imaging (except stricture)
111 Consensus on Celiac Disease: Diagnosis 4/6/2017Consensus on Celiac Disease: DiagnosisCeliac 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 T Ponchon 4/6/2017Preps & ProkineticsPanel Co-ChairmenK MergenerT PonchonPanel 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: 4/6/2017Clinical ChallengesLimitations of capsule endoscopy in somecases:Dark/opaque intestinal contents, bubbles, food/medication particles, fecal matter, impairing visualization of the mucosa
114 Clinical Challenges (continued) 4/6/2017Clinical Challenges (continued)Limitations of capsule endoscopy in somecases:Slow gastric emptying and/or small bowel transit, leading to incomplete small bowel imaging in approximately 15-20% of cases
115 4/6/2017ASGE CE SIG SurveyDo you routinely use a laxative prior to SB capsule exams?YesNo
116 4/6/2017ASGE CE SIG SurveyIf “yes”, which laxative do you use?
117 4/6/2017ASGE CE SIG SurveyDo you routinely use a prokinetic agent prior to SB CE?YesNo
118 4/6/2017ASGE CE SIG SurveyIf “yes”, which type of prokinetic agent do you use?
119 4/6/2017DefinitionsBowel 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 4/6/20171. 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 4/6/2017General Comments – Limitations to the Consensus Review ProcessApproximately 70 reportsFew large randomized controlled trialsFewer peer-reviewed publicationsMany small retrospective seriesPublication biasMultiple studies from same institutionDifferent types of agents, different administration schedules, combinations of agents, etc.
122 4/6/2017PrepsNo validated scale is available (subjective global assessment vs. more precise analysis of individual frames)Total of 17 studies, 9 randomizedOnly 3 of 9 included more than 100 patientsOnly 1 of 9 published as peer-reviewed article
123 Preps – Recent Abstracts 4/6/2017Preps – Recent AbstractsPons et al., DDW 2006 Gastrointestinal Endosc 63(4): AB M1284:291 patients(A) 4L clear liquids, (B) 90ml NaPhos, (C) 4L PEGNO SIGNIFICANT DIFFERENCESLapalus et al., ICCE 2006:AB123 patients(A) 12 hour fast, (B) 90ml NaPhosNO SIGNIFICANT DIFFERENCEWi et al., Gastrointest Endosc 2006;63(4): AB M1310125 patients(A) 12 hour fast, (B) 90ml NaPhos, (C) 2L PEGIMPROVED VISIBILITY AND IMPROVED DIAGNOSTIC YIELD WITH NaPHOS (BUT NOT WITH PEG)
124 Preps – Peer-reviewed Article 4/6/2017Preps – Peer-reviewed ArticleViazis et al. GIE 2004;60:534-8Prospective, randomized, blinded80 patientsPEG 2L vs. clear liquids onlyGrading: “adequate” vs. “inadequate”Cleansing “adequate”: 36pts (90%) vs. 24pts (60%)Diagnosis established: 26pts (65%) vs. 12pts (30%)
125 Preps – Consensus Conclusions 4/6/2017Preps – Consensus ConclusionsPreps 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. 4/6/2017ProkineticsProkinetics 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 4/6/2017Positioning / Other IssuesRight lateral decubitus position3 abstracts, non-randomizedEvaluation of GTT onlyStatistically significant difference in 1 of 3 studiesToo few data to reach firm conclusionPredictive factors for incomplete SB examAge, inpatient status and diabetes may be among the predictive factors of incomplete SB examinationNot enough data to draw firm conclusions regarding the use of preps/prokinetics or postural maneuvers in these subgroups
128 Preps & Prokinetics 2006 Consensus Conclusions 4/6/2017Preps & Prokinetics 2006 Consensus Conclusions1. Has a scale been validated to evaluate SB cleanliness?No2. Do preps affect SB cleanliness?Possibly No3. Do preps affect the diagnostic yield of SB CE?Unknown4. 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