WASh multicentre randomised controlled trial: water-assisted sigmoidoscopy in English NHS bowel scope screening.

OBJECTIVES: The English Bowel Cancer Screening Programme invites 55 year olds for a sigmoidoscopy (Bowel Scope Screening (BSS)), aiming to resect premalignant polyps, thus reducing cancer incidence. A national patient survey indicated higher procedural pain than anticipated, potentially impacting on screening compliance and effectiveness. We aimed to assess whether water-assisted sigmoidoscopy (WAS), as opposed to standard CO2 technique, improved procedural pain and detection of adenomatous polyps. DESIGN: The WASh (Water-Assisted Sigmoidoscopy) trial was a multicentre, single-blind, randomised control trial for people undergoing BSS. Participants were randomised to either receive WAS or CO2 from five sites across England. The primary outcome measure was patient-reported moderate/severe pain, as assessed by patients on a standard Likert scale post procedure prior to discharge. The key secondary outcome was adenoma detection rate (ADR). The costs of each technique were also measured. RESULTS: 1123 participants (50% women, mean age 55) were randomised (561 WAS, 562 CO2). We found no difference in patient-reported moderate/severe pain between WAS and CO2 (14% in WAS, 15% in CO2; p=0.47). ADR was 15% in the CO2 arm and 11% in the WAS arm (p=0.03); however, it remained above the minimum national performance standard in both arms. There was no statistical difference in mean number of adenomas nor overall polyp detection rate. There was negligible cost difference between the two techniques. CONCLUSION: In the context of enema-prepared unsedated screening sigmoidoscopies performed by screening-accredited endoscopists, no difference in patient-reported pain was seen when using either a CO2 or WAS intubation technique. TRIAL REGISTRATION NUMBER: ISRCTN81466870.

Endoscopic cuff-assisted colonoscopy versus cap-assisted colonoscopy in adenoma detection: randomized tandem study-DEtection in Tandem Endocuff Cap Trial (DETECT).

BACKGROUND AND AIMS: Adenoma miss rate during colonoscopy is directly linked to risk of postcolonoscopy colorectal cancer. One of the reasons for missed adenomas is poor visualization of proximal folds during standard colonoscopy withdrawal. Disposable distal attachments such as the plastic cap and Endocuff (Arc Medical Design, Leeds, UK) that hold back folds appear to improve adenoma detection. The primary aim of this study was to compare adenoma detection rates between Endocuff-assisted colonoscopy (EAC) and cap-assisted colonoscopy (CAC). METHODS: This is a randomized, single-center, tandem colonoscopy trial performed by the same endoscopists on the same day, first with Endocuff Vision (Arc Medical Design, Leeds, UK) followed by cap or vice versa. All procedures were performed by 3 experienced gastroenterology fellows. RESULTS: One hundred fifty-four patients were recruited. Seventy-eight (50.6%) had CAC as their first procedure. Mean patient age was 61 years (male-to-female ratio, 1:1). Adenoma detection rate was significantly higher for EAC when compared to CAC (53% vs 26%, P = .001). Polyp miss rate was significantly lower in EAC (8.4%) compared with CAC (26.1%, P < .001) as was adenoma miss rate (EAC vs CAC, 6%, vs 19%; P = .002) and diminutive adenoma (<5 mm) miss rate in the EAC group (1.8% vs 19.6%, P < .001). However, there was no significant differences in the miss rates for small adenomas (5-9 mm) (3.7% vs 2.9%, P = .69) or adenomas 10 mm or larger (1.6% vs 2.6%, P = .98 ). The mean number of adenomas per procedure was significantly higher with EAC compared with CAC (1.5 vs .8, P < .001). Cecal intubation time was significantly shorter with EAC than CAC (median 6 vs 7 minutes, P = .01). Conversely, withdrawal time (median 10 vs 8 minutes, P = .01) was significantly longer in EAC. CONCLUSIONS: This randomized, tandem study demonstrates that EAC has a significantly higher adenoma detection rate and lower adenoma miss rate than CAC. Although insertion times were shorter with EAC, procedures were slightly more uncomfortable, and the cuff had to be removed in a small number of cases. (Clinical trial registration number: NCT03254498.).

Improved adenoma detection with Endocuff Vision: the ADENOMA randomised controlled trial.

OBJECTIVE: Low adenoma detection rates (ADR) are linked to increased postcolonoscopy colorectal cancer rates and reduced cancer survival. Devices to enhance mucosal visualisation such as Endocuff Vision (EV) may improve ADR. This multicentre randomised controlled trial compared ADR between EV-assisted colonoscopy (EAC) and standard colonoscopy (SC). DESIGN: Patients referred because of symptoms, surveillance or following a positive faecal occult blood test (FOBt) as part of the Bowel Cancer Screening Programme were recruited from seven hospitals. ADR, mean adenomas per procedure, size and location of adenomas, sessile serrated polyps, EV removal rate, caecal intubation rate, procedural time, patient experience, effect of EV on workload and adverse events were measured. RESULTS: 1772 patients (57% male, mean age 62 years) were recruited over 16 months with 45% recruited through screening. EAC increased ADR globally from 36.2% to 40.9% (P=0.02). The increase was driven by a 10.8% increase in FOBt-positive screening patients (50.9% SC vs 61.7% EAC, P<0.001). EV patients had higher detection of mean adenomas per procedure, sessile serrated polyps, left-sided, diminutive, small adenomas and cancers (cancer 4.1% vs 2.3%, P=0.02). EV removal rate was 4.1%. Median intubation was a minute quicker with EAC (P=0.001), with no difference in caecal intubation rate or withdrawal time. EAC was well tolerated but caused a minor increase in discomfort on anal intubation in patients undergoing colonoscopy with no or minimal sedation. There were no significant EV adverse events. CONCLUSION: EV significantly improved ADR in bowel cancer screening patients and should be used to improve colonoscopic detection. TRIAL REGISTRATION NUMBER: NCT02552017, Results; ISRCTN11821044, Results.

Impact of a new distal attachment on colonoscopy performance in an academic screening center.

BACKGROUND AND AIMS: Distal attachments placed on the colonoscope tip may positively affect performance by assisting insertion and polyp detection. The original Endocuff (ARC Medical Design, Leeds, United Kingdom) appears to improve adenoma detection rate (ADR), but no data assess the performance of the second-generation Endocuff Vision. METHODS: A pilot service evaluation study (April 2013 to September 2014) was conducted on patients with positive fecal occult blood tests within the National Bowel Cancer Programme during 3 consecutive periods: precuff/no device used, during-cuff/device used, and postcuff/no device used. During the middle period the use of the Endocuff Vision by the 4 screening-accredited colonoscopists was discretional (nonrandomized design). Data were analyzed using pairwise comparisons during the 3 designated periods to examine key performance indicators: adenoma detection, procedural time, sedation requirements, and patient comfort. RESULTS: Four hundred ten complete colonoscopies were performed (137 precuff, 136 cuff, and 137 postcuff period). Overall, there was a notable increase in the mean ADR of 16% (P < .03) and in the mean number adenoma per procedure (MAP) of 83% (P = .007) from precuff to cuff period. The mean cecal intubation time was statistically lower during the cuff period (7 minutes) in relation to the precuff period (8 minutes; reduction of 12.5%, P = .002) and the postcuff period (9 minutes; increase of 28.6%, P = .002). The mean negative colonoscopy withdrawal time was also significantly lower during the cuff period (8 minutes, 30 seconds) when compared with the precuff (12 minutes) or postcuff period (9 minutes, 45 seconds; P ≤ .001). Multivariate regression analysis showed that the use of the Endocuff Vision was not associated with sedation requirements or patient discomfort scores. No adverse events were reported from the use of the Endocuff Vision, although it was electively removed in 6 patients where severe sigmoid colon diverticulosis was encountered and 2 patients because of discomfort during anal insertion. CONCLUSIONS: In this pilot service evaluation study, the use of the Endocuff Vision appears to be associated with an improvement in overall colonoscopy operator performance. We found increased ADR and MAP as well as decreased time for colonoscope insertion and withdrawal time with no increase in sedation requirements or patient discomfort.

Factors associated with delayed bleeding after resection of large nonpedunculated colorectal polyps.

BACKGROUND: Delayed bleeding is the most common significant complication after piecemeal endoscopic mucosal resection (p-EMR) of large nonpedunculated colorectal polyps (NPCPs). Risk factors for delayed bleeding are incompletely defined. We aimed to determine risk factors for delayed bleeding following p-EMR. METHODS: Data were analyzed from a prospective tertiary center audit of patients with NPCPs ≥ 20 mm who underwent p-EMR between 2010 and 2012. Patient, polyp, and procedure-related data were collected. Four post p-EMR defect factors were evaluated for interobserver agreement and included in analysis. Delayed bleeding severity was reported in accordance with guidelines. Predictors of bleeding were identified. RESULTS: Delayed bleeding requiring hospitalization occurred after 22 of 330 procedures (6.7 %). A total of 11 patients required blood transfusion; of these, 4 underwent urgent colonoscopy, 1 underwent radiological embolization, and 1 required surgery. Interobserver agreement for identification of the four post p-EMR defect factors was moderate (kappa range 0.52 - 0.57). Factors associated with delayed bleeding were visible muscle fibers (P = 0.03) and the presence of a "cherry red spot" (P = 0.05) in the post p-EMR defect. Factors not associated with delayed bleeding were American Association of Anesthesiologists class, aspirin use, polyp size, site, and use of argon plasma coagulation. CONCLUSIONS: Visible muscle fibers and the presence of a "cherry red spot" in the resection defect were associated with delayed bleeding after p-EMR. These findings suggest evaluation and photodocumentation of the post p-EMR defect is important and, when considered alongside other patient and procedural factors, may help to reduce the incidence and severity of delayed bleeding.

A novel multimodality endoscopic device for colonic submucosal dissection using a combination of bipolar radiofrequency and microwave modalities.

BACKGROUND AND STUDY AIMS: Current submucosal dissection devices are technically challenging to use, resulting in long and sometimes incomplete colonic polyp resections. The aim of this feasibility preclinical study was to evaluate a new, multimodality instrument with novel electrocautery properties. METHODS: Six female adult pigs underwent colonic submucosal resections. The novel device was used to cut mucosa and submucosa using bipolar radiofrequency (BRF; at 400 KHz), provide hemostasis with microwave coagulation (MWC; at 5.8 GHz), and inject fluid via a retractable needle. The main outcomes measured were safety (histological analysis post-recovery), performance, and time needed to achieve complete resection. RESULTS: A total of 12 consecutive colonic pseudopolyps were completely excised (two per subject) using BRF cutting. The median time to complete resection was 44.3 minutes (SD 8.9). The median defect size was 32.8 mm (SD 4.3). MWC was applied on 37 occasions for pre-coagulation or treatment of bleeding vessels. One microperforation was treated successfully with endoscopic clips. All animals recovered uneventfully during the 28-day survival period. Histology confirmed adequate healing in all postmortem defects. CONCLUSIONS: In this preclinical evaluation, the novel multimodality endoscopic device facilitated rapid and safe en bloc resection of colonic pseudopolyps.

Bioinformatic and immunological analysis reveals lack of support for measles virus related mimicry in Crohn's disease.

BACKGROUND: A link between measles virus and Crohn's disease (CD) has been postulated. We assessed through bioinformatic and immunological approaches whether measles is implicated in CD induction, through molecular mimicry. METHODS: The BLAST2p program was used to identify amino acid sequence similarities between five measles virus and 56 intestinal proteins. Antibody responses to measles/human mimics were tested by an in-house ELISA using serum samples from 50 patients with CD, 50 with ulcerative colitis (UC), and 38 matched healthy controls (HCs). RESULTS: We identified 15 sets of significant (>70%) local amino acid homologies from two measles antigens, hemagglutinin-neuraminidase and fusion-glycoprotein, and ten human intestinal proteins. Reactivity to at least one measles 15-meric mimicking peptide was present in 27 out of 50 (54%) of patients with CD, 24 out of 50 (48%) with UC (CD versus UC, p = 0.68), and 13 out of 38 (34.2%) HCs (CD versus HC, p = 0.08). Double reactivity to at least one measles/human pair was present in four out of 50 (8%) patients with CD, three out of 50 (6%) with UC (p = 0.99), and in three out of 38 (7.9%) HCs (p >0.05 for all). Titration experiments yielded different extinction curves for anti-measles and anti-human intestinal double-reactive antibodies. Epitope prediction algorithms and three-dimensional modeling provided bioinformatic confirmation for the observed antigenicity of the main measles virus epitopic regions. CONCLUSIONS: Measles sequences mimicking intestinal proteins are frequent targets of antibody responses in patients with CD, but this reactivity lacks disease specificity and does not initiate cross-reactive responses to intestinal mimics. We conclude that there is no involvement of measles/human molecular mimicry in the etiopathogenesis of CD.

Diagnosis and management of iatrogenic endoscopic perforations: European Society of Gastrointestinal Endoscopy (ESGE) Position Statement.

This Position Paper is an official statement of the European Society of Gastrointestinal Endoscopy (ESGE). It addresses the diagnosis and management of iatrogenic perforation occurring during diagnostic or therapeutic digestive endoscopic procedures. Main recommendations 1 ESGE recommends that each center implements a written policy regarding the management of iatrogenic perforation, including the definition of procedures that carry a high risk of this complication. This policy should be shared with the radiologists and surgeons at each center. 2 In the case of an endoscopically identified perforation, ESGE recommends that the endoscopist reports: its size and location with a picture; endoscopic treatment that might have been possible; whether carbon dioxide or air was used for insufflation; and the standard report information. 3 ESGE recommends that symptoms or signs suggestive of iatrogenic perforation after an endoscopic procedure should be carefully evaluated and documented, possibly with a computed tomography (CT) scan, in order to prevent any diagnostic delay. 4 ESGE recommends that endoscopic closure should be considered depending on the type of perforation, its size, and the endoscopist expertise available at the center. A switch to carbon dioxide insufflation, the diversion of luminal content, and decompression of tension pneumoperitoneum or tension pneumothorax should also be done. 5 After closure of an iatrogenic perforation using an endoscopic method, ESGE recommends that further management should be based on the estimated success of the endoscopic closure and on the general clinical condition of the patient. In the case of no or failed endoscopic closure of the iatrogenic perforation, and in patients whose clinical condition is deteriorating, hospitalization and surgical consultation are recommended.

A new accessory, endoscopic cuff, improves colonoscopic access for complex polyp resection and scar assessment in the sigmoid colon (with video).

BACKGROUND: Difficult and unstable endoscopic access to large sessile/flat colon polyps in the sigmoid colon may prevent successful and complete EMR. OBJECTIVE: We report our experience with the use of an endoscopic cuff, a new endoscopic accessory, to improve endoscopic access during endoscopic therapy and scar assessment. DESIGN: Single-center, retrospective, feasibility case series. SETTING: Tertiary referral academic endoscopy unit. PATIENTS: Nonconsecutive patients referred for endoscopic resection of large flat/sessile sigmoid colon polyps or surveillance of postpolypectomy scars in the sigmoid colon. INTERVENTIONS: When conventional methods to achieve stable access and visualization were unsuccessful, the endoscopic cuff was used to retract sigmoid colon folds. MAIN OUTCOME MEASUREMENTS: Safety, procedural success, and complications. RESULTS: Five patients (mean age 62 years, 3 male/2 female) underwent endoscopic cuff-assisted EMR polypectomy, and 7 patients (mean age 62 years, 2 male/5 female) underwent post-EMR scar surveillance with an endoscopic cuff-assisted flexible sigmoidoscopy. All sessile/flat polyps (mean size 29 mm) or post-EMR scar sites (mean size 15 mm) were located at acute bends in the sigmoid colon. With the endoscopic cuff placed around the tip of the colonoscope, endoscopic access improved significantly by flattening/depressing colon folds close to the lesion/scar. The entire polyp/scar surface was revealed, facilitating a complete polyp excision and a meticulous scar assessment. No immediate or delayed adverse events were seen. LIMITATIONS: Single-center, nonrandomized case series. CONCLUSIONS: An endoscopic cuff appears to be a safe and easily used accessory to facilitate colonoscopic access for complex polypectomy and scar assessment in the sigmoid colon.

Endoscopic mucosal ablation: a new argon plasma coagulation/injection technique to assist complete resection of recurrent, fibrotic colon polyps (with video).

BACKGROUND: Incomplete piecemeal EMR of large, sessile/flat colon polyps results in polyp recurrence, with massive submucosal scarring making subsequent attempts at endoscopic resection problematic. OBJECTIVE: We report our experience with a new endoscopic mucosal ablation (EMA) technique that can be used to complement the eradication of recurrent fibrotic colon polyps. DESIGN: Single-center, retrospective case series. SETTING: Tertiary-care referral academic endoscopy unit. PATIENTS: This study involved consecutive patients referred for endoscopic excision of recurrent benign colon polyps with severe submucosal fibrosis (>30% of the entire lesion). INTERVENTION: Application of high-power argon plasma coagulation (APC), preceded by injection of a submucosal fluid cushion (normal saline/diluted adrenaline and/or sodium hyaluronate solution) to protect the muscle layer, was performed to augment further piecemeal EMR and polyp eradication. MAIN OUTCOME MEASUREMENTS: Technical safety and success, complication and recurrence rates. RESULTS: Fourteen patients (mean age 73 years; 9 men, 5 women) with 15 recurrent colon adenomas (mean polyp size 30 mm, 9 proximal/6 distal) were included. EMA with a mean APC power setting of 55 W was applied. Complete polyp eradication was achieved in 9 of 11 patients (82%) at first or second completed follow-up. One patient needed laparoscopic colectomy because of cancer, and 1 underwent transanal endoscopic microsurgery for benign massive recurrence. The other 3 patients with small, easily treatable recurrence (≤3 mm) were followed by 1-year-surveillance. No perforations and no postpolypectomy syndrome were reported. LIMITATIONS: Single-center, nonrandomized case series with short duration follow-up. CONCLUSION: EMA appears to be a safe and easily applicable technique to assist the complete eradication of recurrent fibrotic colon polyps.

Complications of diagnostic upper Gastrointestinal endoscopy: common and rare - recognition, assessment and management.

A clear understanding of the potential complications or adverse events (AEs) of diagnostic endoscopy is an essential component of being an endoscopist. Creating a culture of safety and prevention of AEs should be part of routine endoscopy practice. Appropriate patient selection for procedures, informed consent, periprocedure risk assessments and a team approach, all contribute to reducing AEs. Early recognition, prompt management and transparent communication with patients are essential for the holistic and optimal management of AEs. In this review, we discuss the complications of diagnostic upper gastrointestinal endoscopy, including their recognition, treatment and prevention.

Effect of sleep on excessive belching: a 24-hour impedance-pH study.

UNLABELLED: In patients with repetitive and troublesome belching an organic cause is seldom found, indicating the presence of an acquired abnormal behavior. The aim of our study was to investigate the incidence and pattern of belching during a 24-hour period. METHODS: Combined 24-hour pH and intraluminal impedance monitoring was performed in 14 patients (9 female; mean age: 43 y) with excessive belching and 10 patients (6 women, mean age 42 y; range 28 to 56) with noncardiac chest pain. Thereafter, we counted the number of belching events and differentiated the number of supragastric and gastric belches. RESULTS: During the 24-hour study, the hourly rate of belching was 38.7+/-6.0; rate of supragastric belches were significantly higher compared to gastric belches (37.7+/-6.0 vs 1.0+/-0.5, P<0.001). Patients with noncardiac chest pain showed a lower average hourly rate of belching (3.1+/-0.6, P<0.001). Dividing the recording into 2 periods (daily-upright and night-supine), there was a significant decrease in the hourly rate at night (37.8+/-6.1 vs. 0.9+/-0.5, respectively, P<0.001); mostly due to decrease in supragastric belches, where as the rate of gastric belches remained unchanged. None of the patients showed pathological acid reflux and none of the supragastric belches was associated with acid or nonacid reflux events. CONCLUSIONS: Supragastric belch is the prominent belching pattern in patients with excessive belching. Supragastric belches almost ceased at night suggesting the presence of a behavioral disorder. There were no diurnal changes in the rate of gastric belches.

Endoscopic submucosal dissection and tunneling procedures using a novel all-in-one bipolar device.

Background and study aims Recent innovations in devices and techniques have revolutionized the field of endoscopic resection procedures. In this study, we evaluated the safety and feasibility of endoscopic submucosal dissection and tunneling procedures with a novel, multipurpose bipolar device. Patients and methods Data from consecutive patients who underwent per-oral endoscopic myotomy (POEM), submucosal tunneling endoscopic resection (STER), and endoscopic submucosal dissection (ESD) using a novel bipolar device (December 2019 to February 2020) were analyzed retrospectively. Procedure duration, technical success, and adverse events (AEs) were recorded. Results A total of 10 procedures were performed using the novel bipolar device during the study period. The procedures included POEM (n = 7), STER for esophageal sub-epithelial tumor (n = 1), ESD for rectal polyp (n = 1), and gastric neuroendocrine tumor (n = 1). POEM was successfully completed in all patients. In patients who underwent STER and ESD, en-bloc resection was achieved in all. Mean procedure time for submucosal tunneling procedures (POEM and STER) was 59.12 ±â€Š31.12 minutes. The procedures were completed without the requirement for exchange of accessories in eight cases (80 %). There were no major AEs. Mild and moderate AEs occurred during POEM and included capno-peritoneum (n = 1), retroperitoneal CO 2 (n = 1), and empyema (n = 1). Conclusion ESD and tunneling procedures can be safely performed without the need for exchange of accessories using a novel bipolar device. Randomized comparison with conventional knives isrequired to confirm the utility of this device.