Effect of prophylactic endoscopic clip placement on clinically significant post-endoscopic mucosal resection bleeding in the right colon: a single-centre, randomised controlled trial.

BACKGROUND: Endoscopic mucosal resection (EMR) is a cornerstone in the management of large (≥20 mm) non-pedunculated colorectal polyps. Clinically significant post-EMR bleeding occurs in 7% of cases and is most frequently encountered in the right colon. We aimed to assess the use of prophylactic clip closure in preventing clinically significant post-EMR bleeding within the right colon. METHODS: We conducted a randomised controlled trial at a tertiary centre in Australia. Patients referred for the EMR of large non-pedunculated colorectal polyps in the right colon were eligible. Patients were randomly assigned (1:1) into the clip or control (no clip) group, using a computerised random-number generator. The primary endpoint was clinically significant post-EMR bleeding, defined as haematochezia necessitating emergency department presentation, hospitalisation, or re-intervention within 14 days post-EMR, which was analysed on the basis of intention-to-treat principles. The trial is registered with ClinicalTrials.gov, NCT02196649, and has been completed. FINDINGS: Between Feb 4, 2016, and Dec 15, 2020, 231 patients were randomly assigned: 118 to the clip group and 113 to the control group. In the intention-to-treat analysis, clinically significant post-EMR bleeding was less frequent in the clip group than in the control group (four [3·4%] of 118 patients vs 12 [10·6%] of 113; p=0·031; absolute risk reduction 7·2% [95% CI 0·7-13·8]; number needed to treat 13·9). There were no differences between groups in adverse events, including delayed perforation (one [<1%] in the clip group vs one [<1%] in the control group) and post-EMR pain (four [3%] vs six [5%]). No deaths were reported. INTERPRETATION: Prophylactic clip closure can be performed following the EMR of large non-pedunculated colorectal polyps of 20 mm or larger in the right colon to reduce the risk of clinically significant post-EMR bleeding. FUNDING: None.

A prospective, randomized, placebo-controlled trial of transdermal glyceryl trinitrate in ERCP: effects on technical success and post-ERCP pancreatitis.

BACKGROUND: Despite the recent improvement in techniques and patient selection, post-ERCP pancreatitis remains the most frequent and dreaded complication of ERCP. Recent studies suggest that pretreatment with glyceryl trinitrate (GTN) may prevent post-ERCP pancreatitis and improve cannulation success. OBJECTIVE: To evaluate the effect of transdermal GTN on ERCP cannulation success and post-ERCP pancreatitis. DESIGN: Prospective, double-blind, placebo-controlled trial. SETTING: Tertiary referral university hospital. PATIENTS: A total of 318 patients (mean age 62 years, 61% women) were randomized to either active (n = 155) or placebo (n = 163) arms. INTERVENTIONS: Active patch (GTN) versus placebo patch. MAIN OUTCOME MEASUREMENTS: Cannulation time and success. Post-ERCP pancreatitis rates. RESULTS: There was no significant difference between the active or placebo arms for the following: successful initial cannulation (96.8% vs 98.8%), deep cannulation (96.1% vs 98.8%), time to successful cannulation, use of guidewire (27% vs 25%) or needle knife (13% vs 13%), and post-ERCP pancreatitis (7.4% of placebo patients and 7.7% active patients). Multivariate analysis identified women, younger patients, pancreatogram, number of attempts on papilla, and poor pancreatic-duct emptying after opacification as risk factors for post-ERCP pancreatitis. Transdermal GTN did not reduce post-ERCP pancreatitis in any of the identified high-risk groups. CONCLUSIONS: Transdermal GTN did not improve the rate of success in ERCP cannulation or prevent post-ERCP pancreatitis in either average or high-risk patient groups.

Impact of endoscopic intervention in 100 patients with suspected postcholecystectomy bile leak.

BACKGROUND: Bile leak is a recognized complication of cholecystectomy. Endoscopic intervention is widely accepted as a treatment for this complication, but the optimal form is not well defined. METHODS: An ERCP database was reviewed retrospectively to identify all cases of bile leak related to cholecystectomy. Patient records and endoscopy reports were reviewed, and structured telephone interviews were conducted to collect data. RESULTS: A total of 100 patients (61 women, 39 men; mean age, 53 [17] years) with suspected postcholecystectomy bile leak were referred for ERCP. Cholecystectomy was commenced laparoscopically in 83 patients (with an open conversion rate of 30%). The most common symptoms were pain (n = 62) and fever (n = 37). Cholangiography was obtained in 96 patients. A leak was identified in 80/96 patients, the most common site being the cystic-duct stump (48), followed by ducts of Luschka (15), the T-tube site (7), and other sites (10). Treatment included stent insertion alone (40), sphincterotomy alone (18), combination stent/sphincterotomy (31), none (6), and other (1). Three patients with major bile-duct injuries were excluded from the analysis. Endoscopic therapy was unsuccessful in 7 patients (6 in the sphincterotomy alone group; p = 0.001). Four patients underwent surgery subsequent to ERCP to control the leak. All 4 were in the sphincterotomy alone group ( p = 0.001). Post-ERCP pancreatitis developed in 4 patients (3 mild, 1 moderate). CONCLUSIONS: The optimal endoscopic intervention for postcholecystectomy bile leak should include temporary insertion of a biliary stent.

A prospective trial of variable stiffness pediatric vs. standard instrument colonoscopy.

BACKGROUND: The pediatric variable stiffness colonoscope is believed to have theoretical advantages over the standard colonoscope, however a systematic evaluation of this instrument in routine clinical practice involving adult patients is lacking. METHODS: Consecutive patients (blinded) undergoing colonoscopy in an outpatient endoscopy center by one of 4 experienced colonoscopists had the procedure performed with a standard colonoscope (n=384) or pediatric variable stiffness colonoscope (n=413). Failure to negotiate the sigmoid colon within 10 minutes was regarded as a failure and, if suitable, the patient was crossed over to colonoscopy with the alternative instrument. RESULTS: Median (95% CI) time to the cecum was significantly faster in the pediatric variable stiffness colonoscope group (odds ratio 5.0: 95% CI[4.7,5.3] minutes) compared with the standard colonoscope group (odds ratio 5.5: 95% CI[5.2,5.8] minutes, p=0.01). There were 22 failures overall (2.8%), 14 in the standard colonoscope group (3.6%) and 8 in the pediatric variable stiffness colonoscope group (1.9%; p=0.1). With regard to the 14 failures in the standard colonoscope group, colonoscopy was attempted with the pediatric variable stiffness colonoscope in 13 and completed successfully in 12 (92%). The pediatric variable stiffness colonoscope was superior in cases of severe stenosing diverticular disease; two of 27 examinations with the pediatric variable stiffness colonoscope were rated as failed vs. 12 of 18 with the standard colonoscope (p<0.001). CONCLUSIONS: Intubation time was faster with the pediatric variable stiffness colonoscope, but use of this instrument was not associated with a superior cecal intubation rate compared with the standard colonoscope. However, in patients with severe stenosing diverticular disease, the intubation rate with the pediatric variable stiffness colonoscope was superior.