Effect of Different Modalities of Purgative Preparation on the Diagnostic Yield of Small Bowel Capsule for the Exploration of Suspected Small Bowel Bleeding: A Multicenter Randomized Controlled Trial.

INTRODUCTION: The aim of our study was to compare clear liquid diet with 2 different polyethylene glycol (PEG)-based bowel preparation methods regarding diagnostic yield of small bowel capsule endoscopy (SBCE) in patients with suspected small bowel bleeding (SBB). METHODS: In this prospective multicenter randomized controlled trial, consecutive patients undergoing SBCE for suspected SBB between September 2010 and February 2016 were considered. Patients were randomly assigned to standard regimen, that is, clear fluids only (prep 1), standard regimen plus 500 mL PEG after SBCE ingestion (prep 2), or standard regimen plus 2 L PEG plus 500 mL PEG after SBCE ingestion (prep 3). The primary outcome was the detection of at least one clinically significant lesion in the small bowel. The quality of small bowel cleansing was assessed. A questionnaire on the clinical tolerance was filled by the patients. RESULTS: We analyzed 834 patients. No significant difference was observed for detection of P1 or P2 small bowel lesions between prep1 group (40.5%), prep 2 group (40.2%), and prep 3 group (38.5%). Small bowel cleansing was improved in prep 2 and 3 groups compared with that in prep 1 group. Compliance to the preparation and tolerance was better in prep 2 group than in prep 3 group. DISCUSSION: Small bowel purgative before SBCE allowed better quality of cleansing. However, it did not improve diagnostic yield of SBCE for suspected SBB.

Screening of esophageal varices by esophageal capsule endoscopy: results of a French multicenter prospective study.

BACKGROUND AND STUDY AIM: Esophageal video capsule endoscopy (ECE) is a new technique that allows examination of the esophagus using a noninvasive approach. The aim of this study was to compare ECE with esophagogastroduodenoscopy (EGD) for the diagnosis of esophageal varices in patients with cirrhosis. PATIENTS AND METHODS: A total of 330 patients with cirrhosis and with no known esophageal varices were prospectively enrolled. Patients underwent ECE first, followed by EGD (gold standard). The endoscopists who performed EGD were blind to the ECE result. Patient satisfaction was assessed using a visual analog scale (maximum score 100). RESULTS: A total of 30 patients were excluded from the analysis because they did not undergo any endoscopic examinations. Patients (mean age 56 years; 216 male) had mainly alcoholic (45 %) or viral (27 %) cirrhosis. The diagnostic indices of ECE to diagnose and correctly stage esophageal varices were: sensitivity 76 % and 64 %, specificity 91 % and 93 %, positive predictive value 88 % and 88 %, and negative predictive value 81 % and 78 %, respectively. ECE patient satisfaction scored significantly higher than EGD (87 ±â€Š22 vs. 58 ±â€Š35; P < 0.0001). CONCLUSIONS: ECE was well tolerated and safe in patients with liver cirrhosis and suspicion of portal hypertension. The sensitivity of ECE is not currently sufficient to replace EGD as a first exploration in these patients. However, due to its excellent specificity and positive predictive value, ECE may have a role in cases of refusal or contraindication to EGD. ECE might also improve compliance to endoscopic follow-up and aid important therapeutic decision making in the prophylaxis of bleeding. TRIAL REGISTRATION: EudraCT (ID RCB 2009-A00532-55) and ClinicalTrials.gov (NCT00941421).

Small bowel capsule endoscopy in obscure gastrointestinal bleeding: A matched cohort comparison of patients with normal vs surgically altered gastric anatomy.

BACKGROUND: Little is known about small bowel capsule endoscopy (SBCE) outcomes in patients with surgically altered anatomy. AIMS: To assess the feasibility and diagnostic yield of orally ingested SBCE to investigate obscure gastrointestinal bleeding (OGIB) in patients with surgically altered gastric anatomy, compared to native gastric anatomy. METHODS: 207 patients with OGIB were selected from an open, multicenter, retrospective cohort (SAGA study) and match-paired according to age, gender and bleeding type (overt/occult) to 207 control patients from a randomized controlled trial (PREPINTEST). Primary outcomes were the diagnostic yield (P1 or P2 findings), completion rate, adverse events rate, and small bowel transit time (SBTT). RESULTS: The diagnostic yield was not statistically different between groups (44.9% in SAGA vs 42.5% in control patients). Inflammatory/ulcerated lesions were significantly more frequent in patients with SAGA (43.0% vs 29.3%). The median SBTT was significantly longer in the SAGA group than in control patients (283 vs 206 minutes), with a significantly lower completion rate (82.6% vs 89.9%); Adverse events were scarce (0.5% vs 0.0%). CONCLUSION: Patients with surgically altered gastric anatomy should benefit from SBCE investigation for OGIB as much as non-operated patients.

Prospective, randomized comparison of two small-bowel capsule endoscopy systems in patients with obscure GI bleeding.

BACKGROUND: Video capsule endoscopy is the first-intention examination in patients with obscure GI bleeding. The new MiroCam capsule, when using electric-field propagation for transmission, has been poorly evaluated in a clinical setting, in contrast with the PillCam SB2 capsule. OBJECTIVE: To evaluate the diagnostic concordance (κ value) between PillCam SB2 and MiroCam capsule examinations performed in the same patients. DESIGN AND SETTING: Prospective, randomized study in 7 endoscopy units. PATIENTS AND INTERVENTION: Eighty-three consecutive patients, ingesting the 2 capsules at a 1-hour interval. RESULTS: Seventy-three patients were analyzed (10 technical issues). There were 31 concordant negative cases (42.4%) and 30 concordant positive cases (41.1%). The study showed satisfactory diagnostic concordance between the 2 systems (κ = 0.66). In 12 patients (16.4%), the final diagnosis was different: 9 patients had positive findings on MiroCam examination but no image detected with PillCam SB2, 2 had positive findings on PillCam examination only, and 1 patient had 2 different diagnoses. A positive diagnosis was obtained in 46.6% and 56.2% of patients with PillCam SB2 and MiroCam capsule, respectively, so that the procedures identified 78.6% and 95.2% of positive cases, respectively (P = .02). Small-bowel transit time and capsule reading time were significantly longer in MiroCam procedures. LIMITATIONS: Technical failures possibly related to capsule interference. CONCLUSION: This study shows at least comparable efficiency of the MiroCam compared with the PillCam SB2 capsule system for the diagnosis of obscure GI bleeding.

Prospective evaluation of third-generation small bowel capsule endoscopy videos by independent readers demonstrates poor reproducibility of cleanliness classifications.

OBJECTIVE: The detection of lesions during small bowel (SB) capsule endoscopy (CE) depends on the cleanliness of the intestine. Quality reporting and comparison of different preparation methods require reliable scores. Three scores known as quantitative index (QI), qualitative evaluation (QE), and overall adequacy assessment (OAA), have been proposed to assess SB cleanliness, and are sometimes used in clinical practice and in clinical trials. However, none of these scores has received any external validation. The aim of our study was to re-assess the reproducibility of these three specific scores. METHODS: One-hundred-and-fifty-five complete third-generation SB-CE video recordings were extracted from a multicenter randomized controlled trial (PREPINTEST) which evaluated three modalities of SB preparation for CE. Three experts independently read the 155 SB-CE video recordings twice, in a random order, over 48 -h periods at 6-week intervals, using the QI, QE and OAA scores. Cohen's linearly weighted kappa coefficients were calculated to assess intra-observer and inter-observer agreements. RESULTS: Intra-observer reproducibility was fair to moderate, with kappa coefficients between 0.37 and 0.46 for QI, 0.41 and 0.51 for QE, 0.41 and 0.50 for OAA. Inter-observer reproducibility was fair to substantial according to kappa coefficients between experts varying from 0.40 to 0.64, 0.29 to 0.65, and 0.52 to 0.71, for QI, QE and OAA, respectively. CONCLUSIONS: QI, QE and OAA scores, currently used for evaluation of the quality of the preparation of SB-CE, are not sufficiently reproducible. Other scores or methods are therefore needed for SB-CE cleanliness assessment.

Factors of accuracy of transient elastography (fibroscan) for the diagnosis of liver fibrosis in chronic hepatitis C.

UNLABELLED: The purpose of this study was to assess the influence of success rate and interquartile range on the accuracy of transient elastography for the diagnostic of fibrosis in hepatitis C virus infection. Two-hundred fifty-four consecutive patients had liver stiffness measurements and liver biopsy of at least 15 mm. Discordances of at least two stages between transient elastography and histological assessment were observed in 28 cases (11%). Factors of discordance were assessed by comparing the 28 misclassified cases with the 226 others. In multivariate analysis, fibrosis stage (F0-F2 versus F3-F4) and the ratio interquartile range/median value of liver stiffness measurement (IQR/M) were associated with discordances (P or= 0.21, discordances of at least two stages of fibrosis were respectively observed in 10 of 135 cases (7.4%) versus 18 of 119 cases (15.1%) (P or= 0.21 versus IQR/M < 0.21, for the diagnosis of liver fibrosis F >or= 2, F >or= 3, F = 4, areas under the receiver operating characteristic curve (AUROCs) were 0.80 (95% confidence interval [CI], 0.73-0.89) versus 0.81 (95% CI, 0.70-0.90), (P = NS); 0.80 (95% CI, 0.72-0.88) versus 0.89 (95% CI, 0.83-0.95) (P = 0.04); and 0.86 (95% CI, 0.77-0.94) versus 0.95 (95% CI, 0.92-0.99) (P = NS). No association was found between success rate and discordance. CONCLUSION: IQR/M is a factor of overestimation of liver fibrosis, and the most discriminant cutoff value is 0.21. Success rate is not a factor of accuracy for the diagnosis of hepatic fibrosis.

CAD-CAP: a 25,000-image database serving the development of artificial intelligence for capsule endoscopy.

Background and study aims Capsule endoscopy (CE) is the preferred method for small bowel (SB) exploration. With a mean number of 50,000 SB frames per video, SBCE reading is time-consuming and tedious (30 to 60 minutes per video). We describe a large, multicenter database named CAD-CAP (Computer-Assisted Diagnosis for CAPsule Endoscopy, CAD-CAP). This database aims to serve the development of CAD tools for CE reading. Materials and methods Twelve French endoscopy centers were involved. All available third-generation SB-CE videos (Pillcam, Medtronic) were retrospectively selected from these centers and deidentified. Any pathological frame was extracted and included in the database. Manual segmentation of findings within these frames was performed by two pre-med students trained and supervised by an expert reader. All frames were then classified by type and clinical relevance by a panel of three expert readers. An automated extraction process was also developed to create a dataset of normal, proofread, control images from normal, complete, SB-CE videos. Results Four-thousand-one-hundred-and-seventy-four SB-CE were included. Of them, 1,480 videos (35 %) containing at least one pathological finding were selected. Findings from 5,184 frames (with their short video sequences) were extracted and delimited: 718 frames with fresh blood, 3,097 frames with vascular lesions, and 1,369 frames with inflammatory and ulcerative lesions. Twenty-thousand normal frames were extracted from 206 SB-CE normal videos. CAD-CAP has already been used for development of automated tools for angiectasia detection and also for two international challenges on medical computerized analysis.

Oesophageal capsule endoscopy versus oesophago-gastroduodenoscopy for the diagnosis of recurrent varices: a prospective multicentre study.

BACKGROUND: Oesophago-gastroduodenoscopy is the standard method for the diagnosis of recurrent oesophago-gastric varices after endoscopic treatment and eradication. The aim of this study was to evaluate the PillCam Eso capsule endoscopy in this setting. METHODS: Prospective, multicentre study in which patients with history of oesophageal varices treated by band ligation underwent PillCam Eso capsule and oesophago-gastroduodenoscopy. Capsule recordings were blindly read by two endoscopists. Indication for a new prophylactic treatment and patient satisfaction were determined for both procedures. RESULTS: 80 patients (80% males, mean age: 57±12 years) were included, after a median delay of 16 months from last endoscopic treatment. Recurrent oesophageal varices requiring a new prophylactic treatment were detected in 26 patients (32.5%). The mean oesophageal transit time of the capsule was 153 s (range 2-930 s). Capsule sensitivity, specificity, negative and positive predictive values for indication of new prophylactic treatments were 65%, 83%, 83%, and 65%, respectively. Capsule adequately classified 77.5% of the patients for prophylaxis indication. Inter-observer concordance for capsule readings was 88% for the prophylaxis indication. CONCLUSION: This study demonstrates that accuracy of PillCam Eso capsule for the diagnosis of recurrent oesophageal varices after endoscopic eradication is suboptimal. PillCam Eso capsule might therefore be proposed in patients unable or unwilling to undergo oesophago-gastroduodenoscopy.