Endocuff vision vs. standard colonoscopy in the FOBT based UK Bowel cancer screening programme (E-­‐cap study):a randomized trial

Background and study aims Up to 25 % colorectal adenomas are missed during colonoscopy. The aim of this study was to investigate whether the endocuff could improve polyp detection in an organized bowel cancer screening program (BCSP). Patients and methods This parallel group, single-blinded, randomized controlled trial included patients with positive fecal occult blood test (FOBT) who were attending for BCSP colonoscopy. The primary outcome was the number of polyps per patient. Secondary outcomes included the number of adenomas per patient, adenoma and polyp detection rates, and withdrawal times. Results A total of 534 BCSP patients were randomized to endocuff-assisted or standard colonoscopy. The mean age was 67 years and the male to female ratio was 1.8:1. We detected no significant difference in the number of polyps per patient (standard 1.8, endocuff 1.6; P = 0.44), adenomas per patient (standard 1.4, endocuff 1.3; P = 0.54), polyp detection rate (standard 69.8 %, endocuff 70.3 %; P = 0.93), adenoma detection rate (standard 63.0 %, endocuff 60.9 %; P = 0.85), advanced adenoma detection rate (standard 18.5 %, endocuff 16.9 %; P = 0.81), and cancer detection rate (standard 5.7 %, endocuff 5.3 %; P = 0.85). The mean withdrawal time was significantly shorter among patients in the endocuff group compared with the standard colonoscopy group (16.9 vs. 19.5 minutes; P < 0.005). The endocuff had to be removed in 17/266 patients (6.4 %) because of inability to pass through the sigmoid colon. Conclusions This study did not find improved polyp or adenoma detection with endocuff-assisted colonoscopy in the FOBT-positive BCSP population. A shorter withdrawal time with endocuff may reflect improved views and stability provided by the endocuff

Observer agreement for small bowel ultrasound in Crohn’s disease:results from the METRIC trial

Purpose: To prospectively evaluate interobserver agreement for small bowel ultrasound (SBUS) in newly diagnosed and relapsing Crohn’s disease. Methods: A subset of patients recruited to a prospective trial comparing the diagnostic accuracy of MR enterography and SBUS underwent a second SBUS performed by one of a pool of six practitioners, who recorded the presence, activity and location of small bowel and colonic disease. Detailed segmental mural and extra-mural observations were also scored. Interobserver variability was expressed as percentage agreement with a construct reference standard, split by patient cohort, grouping disease as present or absent. Prevalence adjusted bias adjusted kappa (PABAK), and simple percentage agreement between practitioners, irrespective of the reference standard, were calculated. Results: Thirty-eight patients (11 new diagnosis, 27 relapse) were recruited from two sites. Overall percentage agreement for small bowel disease presence against the consensus reference was 82% (52–95% (95%CI)), kappa coefficient (κ) 0.64, (substantial agreement) for new diagnosis and 81%, κ 0.63 (substantial agreement) for the relapsing cohort. Agreement for colonic disease presence was 64%, κ 0.27 (fair agreement) in new diagnosis and 78%,κ 0.56 (moderate agreement) in the relapsing cohort. Simple agreement between practitioners was 84% and 87% for small bowel and colonic disease presence respectively. Practitioners agreed on small bowel disease activity in 24/27 (89%) where both identified disease. Kappa agreement for detailed mural observations ranged from κ 0.00 to 1.00. Conclusion: There is substantial practitioner agreement for small bowel disease presence in newly diagnosed and relapsing CD patients, supporting wider dissemination of enteric US.</p

Observer agreement for small bowel ultrasound in Crohn’s disease:results from the METRIC trial

Purpose: To prospectively evaluate interobserver agreement for small bowel ultrasound (SBUS) in newly diagnosed and relapsing Crohn’s disease. Methods: A subset of patients recruited to a prospective trial comparing the diagnostic accuracy of MR enterography and SBUS underwent a second SBUS performed by one of a pool of six practitioners, who recorded the presence, activity and location of small bowel and colonic disease. Detailed segmental mural and extra-mural observations were also scored. Interobserver variability was expressed as percentage agreement with a construct reference standard, split by patient cohort, grouping disease as present or absent. Prevalence adjusted bias adjusted kappa (PABAK), and simple percentage agreement between practitioners, irrespective of the reference standard, were calculated. Results: Thirty-eight patients (11 new diagnosis, 27 relapse) were recruited from two sites. Overall percentage agreement for small bowel disease presence against the consensus reference was 82% (52–95% (95%CI)), kappa coefficient (κ) 0.64, (substantial agreement) for new diagnosis and 81%, κ 0.63 (substantial agreement) for the relapsing cohort. Agreement for colonic disease presence was 64%, κ 0.27 (fair agreement) in new diagnosis and 78%,κ 0.56 (moderate agreement) in the relapsing cohort. Simple agreement between practitioners was 84% and 87% for small bowel and colonic disease presence respectively. Practitioners agreed on small bowel disease activity in 24/27 (89%) where both identified disease. Kappa agreement for detailed mural observations ranged from κ 0.00 to 1.00. Conclusion: There is substantial practitioner agreement for small bowel disease presence in newly diagnosed and relapsing CD patients, supporting wider dissemination of enteric US.</p

A randomized controlled trial of pre-procedure simethicone and N-acetylcysteine to improve mucosal visibility during gastroscopy – NICEVIS

Background and study aims - Mucosal views can be impaired by residual bubbles and mucus during gastroscopy. This study aimed to determine whether a pre-gastroscopy drink containing simethicone and N-acetylcysteine improves mucosal visualisation.Patients and methods - We conducted a randomized controlled trial recruiting 126 subjects undergoing routine gastroscopy. Subjects were randomized 1:1:1 to receive: A—pre-procedure drink of water, simethicone and N-acetylcysteine (NAC); B—water alone; or C—no preparation. Study endoscopists were blinded to group allocation. Digital images were taken at 4 locations (lower esophagus/upper gastric body/antrum/fundus), and rated for mucosal visibility (MV) using a 4-point scale (1 = best, 4 = worst) by 4 separate experienced endoscopists. The primary outcome measure was mean mucosal visibility score (MVS). Secondary outcome measures were procedure duration and volume of fluid flush required to achieve adequate mucosal views.Results - Mean MVS for Group A was significantly better than for Group B (1.35 vs 2.11,

A randomised controlled trial of EndoRings assisted colonoscopy versus standard colonoscopy

Endorings is a distal attachment consisting of two layers of circular flexible rings that evert mucosal folds. Aims: Investigate if Endorings Colonoscopy (ER) improves polyp and adenoma detection compared to standard colonoscopy (SC).Methods: Multi-centre, parallel group, randomised controlled trial. Results: Total of 556 patients randomised to ER (275) or SC (281). Colonoscopy completed 532/556 (96%) cases. EndoRings removed in 74/275 (27%) patients. Total number of polyps in ER limb 582 vs 515 in SC limb, p=0.04. Total number of adenomas in ER limb 361 vs 343 for SC limb, p=0.49. A statistically significant difference in the mean number of polyps per patient in both the Intention to Treat (ITT) (1.84 SC vs 2.10 ER, p-value 0.027) and Per Protocol (PP) (1.84 SC vs 2.25 ER, p-value 0.004). Conclusions: Our study shows promise for the EndoRings device to improve polyp detection. <br/

Sa1458 Nicevis:results of a randomised controlled trial of simeticone and n-acetylcysteine as a pre-procedure drink to Improve mucosal visibility during diagnostic gastroscopy

Introduction: Despite advances in endoscope technology there is still a significant miss rate of neoplastic lesions during gastroscopy. Mucosal views are frequently impaired by residual bubbles and mucus.Method: We conducted an RCT in 126 patients attending for routine gastroscopy. Subjects were randomised in a 1:1:1ratio to receive a pre-procedure drink of water, simeticone and n-acetylcysteine (Group A), water alone (Group B) or nopreparation (Group C). Study endoscopists were blinded to group allocation. 4 digital images were taken at pre-defined locations during the procedure – lower oesophagus, upper body, antrum &amp; fundus. Images were rated for mucosalvisibility (MV) using a 4 point scale (1 = best, 4 = worst) by 4 blinded experienced endoscopists. Primary outcome measure was mean MV score. Secondary outcome measures were procedure duration and volume of flush required to achieve adequate mucosal views.Results: Groups were well matched for age, gender or indication for endoscopy. Mean MV score for group A was significantly better than for group B and group C (p &lt;0.001 for both comparisons), with no significant difference between groups B and C (p=0.541). Interobserver agreement of MV scores was good (mean kappa 0.464).Mean volume of flush required to achieve adequate mucosal views was significantly lower in group A than group B(p=0.001), and group C (