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.

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 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.

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.).

The WASh Trial: water-assisted sigmoidoscopy in the English Bowel Scope Screening Programme: study protocol for a randomized multicenter trial.

Background and study aims The English National Bowel Scope Screening Programme (BSSP) invites 55-year-olds for a one-off, unsedated flexible sigmoidoscopy (FSIG). Data from BSSP participant-reported experience studies shows 1 in 3 participants report moderate or severe discomfort. Water-assisted colonoscopy (WAS) may improve participants' comfort. The primary objective of this study is to ascertain if post-procedural participant-assessed pain is reduced in WAS compared with carbon dioxide (CO 2 ) insufflation, in invitees undergoing FSIG in BSSP. Patients and methods This is a multicenter, prospective, randomized, two-arm, single-blinded trial designed to evaluate the performance of WAS versus CO 2 insufflation in BSSP. Participants will be randomized to either CO 2 or WAS and will be asked to rate pain post-procedure. Key procedure-related data will be analyzed, including adenoma detection rates (ADR) and degree of sigmoid looping. A cost-effectiveness analysis of WAS versus CO 2 and a discrete choice experiment exploring preferences of participants for attributes of sigmoidoscopy will also be performed. Discussion This is the first trial in the United Kingdom (UK) to investigate the effects of WAS in a screening setting. If the trial shows WAS either reduces pain or increases ADR, this may result in a practice change to implement WAS in screening and non-screening endoscopic practice directly impacting on 256,000 people a year who will undergo BSSP FSIG by 2020. Trial funding came from National Institute for Health Research (NIHR) Research for Patient Benefit (RfPB) supported by the NIHR Clinical Research Network. The trial is actively recruiting. ID: 35866 ISRCTN: 81466870.

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.

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.

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.

Experimental gastric endoscopic submucosal dissection: training in a porcine model.

BACKGROUND: Endoscopic submucosal dissection (ESD) requires special skills and a long procedure time for a quality-controlled procedure. A universal training system remains to be established. Hands-on courses in animal models before advancing to the human colon appear to be essential, especially in Europe. The learning curve is a prerequisite in ESD, in order to improve technical outcomes and decrease the rate of procedural adverse events. METHODS: In the experimental research center of ELPEN Pharmaceuticals, 18 European endoscopists, inexperienced at ESD, performed gastric ESDs in porcine models. The course lasted two days and was conducted under the supervision of experts. RESULTS: A total of 72 of 76 ESDs were completed en bloc (94.7%). The procedural time and cutting speed differed significantly between the first and second day: 48±4.4 vs. 43±4.8 min (P=0.0045), and 1.38±0.20 vs. 1.63±0.23 cm2/min (P=0.0033), respectively. The complications were not significantly different between the two groups: five (13.88%) vs. four (11%) episodes of bleeding (P>0.05). The perforation rate was similar, at two episodes per day (5.55%). We documented an acceptable rate of en bloc resections and complications. CONCLUSION: ESD demands a new level of endoscopic skills in Europe. A formal sequential training program, using porcine models, may benefit countries with a low volume of cases.

Endoscopic mucosal resection and endoscopic submucosal dissection of large colonic polyps.

Almost all large and complex colorectal polyps can now be resected endoscopically. Piecemeal endoscopic mucosal resection (PEMR) is an established technique with fairly low complication risk and good short-term and medium-term outcomes. Several modifications to the basic injection and snare technique have been developed contributing to safer and more complete resections. Delayed bleeding requiring reintervention is the most troublesome complication in 2-7% of patients, particularly in those with comorbidities and large, right-sided polyps. Endoscopic submucosal dissection (ESD) has become popular in Japan and has theoretical advantages over PEMR in providing a complete, en bloc excision for accurate histological staging and reduced local recurrence. These advantages come at the cost of a more complex, expensive and time-consuming procedure with a higher risk of perforation, particularly early in the procedure learning curve. These factors have contributed to the slow adoption of ESD in the West and the challenge to develop new devices and endoscopic platforms that will make ESD easier and safer. Currently, ESD indications are limited to large rectal lesions, in which procedural complications are easily managed, and for colorectal polyps with a high risk of containing tiny foci of early submucosally invasive cancer, whereby ESD may be curative compared with PEMR.

The ADENOMA Study. Accuracy of Detection using Endocuff Vision™ Optimization of Mucosal Abnormalities: study protocol for randomized controlled trial.

BACKGROUND: Colonoscopy is the gold standard investigation for the diagnosis of bowel pathology and colorectal cancer screening. Adenoma detection rate is a marker of high quality colonoscopy and a high adenoma detection rate is associated with a lower incidence of interval cancers. Several technological advancements have been explored to improve adenoma detection rate. A new device called Endocuff Vision™ has been shown to improve adenoma detection rate in pilot studies. METHODS/DESIGN: This is a prospective, multicenter, randomized controlled trial comparing the adenoma detection rate in patients undergoing Endocuff Vision™-assisted colonoscopy with standard colonoscopy. All patients above 18 years of age referred for screening, surveillance, or diagnostic colonoscopy who are able to consent are invited to the study. Patients with absolute contraindications to colonoscopy, large bowel obstruction or pseudo-obstruction, colon cancer or polyposis syndromes, colonic strictures, severe diverticular segments, active colitis, anticoagulant therapy, or pregnancy are excluded. Patients are randomized according to site, age, sex, and bowel cancer screening status to receive Endocuff Vision™-assisted colonoscopy or standard colonoscopy on the day of procedure. Baseline data, colonoscopy, and polyp data including histology are collected. Nurse assessment of patient comfort and patient comfort questionnaires are completed post procedure. Patients are followed up at 21 days and complete a patient experience questionnaire. This study will take place across seven NHS Hospital Trusts: one in London and six within the Northern Region Endoscopy Group. A maximum of 10 colonoscopists per site will recruit a total of 1772 patients, with a maximum of four bowel screening colonoscopists permitted per site. DISCUSSION: This is the first trial to evaluate the adenoma detection rate of Endocuff Vision™ in all screening, surveillance, and diagnostic patient groups. This timely study will guide clinicians as to the role of Endocuff Vision™ in routine colonoscopy. STUDY REGISTRATION: ISRCTN11821044.

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.