Complications of percutaneous transhepatic cholangiography and biliary drainage, a multicenter observational study.

OBJECTIVES: Over 2500 percutaneous transhepatic cholangiography and biliary drainage (PTCD) procedures are yearly performed in the Netherlands. Most interventions are performed for treatment of biliary obstruction following unsuccessful endoscopic biliary cannulation. Our aim was to evaluate complication rates and risk factors for complications in PTCD patients after failed ERCP. METHODS: We performed an observational study collecting data from a cohort that was subjected to PTCD during a 5-year period in one academic and four teaching hospitals. Primary objective was the development of infectious (sepsis, cholangitis, abscess, or cholecystitis) and non-infectious complications (bile leakage, severe hemorrhage, etc.) and mortality within 30 days of the procedure. Subsequently, risk factors for complications and mortality were analyzed with a multilevel logistic regression analysis. RESULTS: A total of 331 patients underwent PTCD of whom 205 (61.9%) developed PTCD-related complications. Of the 224 patients without a pre-existent infection, 91 (40.6%) developed infectious complications, i.e., cholangitis in 26.3%, sepsis in 24.6%, abscess formation in 2.7%, and cholecystitis in 1.3%. Non-infectious complications developed in 114 of 331 patients (34.4%). 30-day mortality was 17.2% (N = 57). Risk factors for infectious complications included internal drainage and drain obstruction, while multiple re-interventions were a risk factor for non-infectious complications. CONCLUSION: Both infectious and non-infectious complications are frequent after PTCD, most often due to biliary drain obstruction.

The Role of Clips in Preventing Delayed Bleeding After Colorectal Polyp Resection: An Individual Patient Data Meta-Analysis.

BACKGROUND & AIMS: Nonpedunculated colorectal polyps are normally endoscopically removed to prevent neoplastic progression. Delayed bleeding is the most common major adverse event. Clipping the resection defect has been suggested to reduce delayed bleedings. Our aim was to determine if prophylactic clipping reduces delayed bleedings and to analyze the contribution of polyp characteristics, extent of defect closure, and antithrombotic use. METHODS: An individual patient data meta-analysis was performed. Studies on prophylactic clipping in nonpedunculated colorectal polyps were selected from PubMed, Embase, Web of Science, and Cochrane database (last selection, April 2020). Authors were invited to share original study data. The primary outcome was delayed bleeding ≤30 days. Multivariable mixed models were used to determine the efficacy of prophylactic clipping in various subgroups adjusted for confounders. RESULTS: Data of 5380 patients with 8948 resected polyps were included from 3 randomized controlled trials, 2 prospective, and 8 retrospective studies. Prophylactic clipping reduced delayed bleeding in proximal polyps ≥20 mm (odds ratio [OR], 0.62; 95% confidence interval [CI], 0.44-0.88; number needed to treat = 32), especially with antithrombotics (OR, 0.59; 95% CI, 0.35-0.99; number needed to treat = 23; subgroup of anticoagulants/double platelet inhibitors: n = 226; OR, 0.40; 95% CI, 0.16-1.01; number needed to treat = 12). Prophylactic clipping did not benefit distal polyps ≥20 mm with antithrombotics (OR, 1.41; 95% CI, 0.79-2.52). CONCLUSIONS: Prophylactic clipping reduces delayed bleeding after resection of nonpedunculated, proximal colorectal polyps ≥20 mm, especially in patients using antithrombotics. No benefit was found for distal polyps. Based on this study, patients can be identified who may benefit from prophylactic clipping. (PROSPERO registration number CRD42020104317.).

Endoscopic techniques to reduce recurrence rates after colorectal EMR: systematic review and meta-analysis.

BACKGROUND: Colorectal endoscopic mucosal resection (EMR) is an effective, safe, and minimally invasive treatment for large lateral spreading and sessile polyps. The reported high recurrence rate of approximately 20% is however one of the major drawbacks. Several endoscopic interventions have been suggested to reduce recurrence rates. We conducted a systematic review and meta-analysis to assess the efficacy of endoscopic interventions targeting the EMR margin to reduce recurrence rates. METHODS: We searched in PubMed and Ovid for studies comparing recurrence rates after interventions targeting the EMR margin with standard EMR. The primary outcome was the recurrence rate at the first surveillance colonoscopy (SC1) assessed histologically or macroscopically. For the meta-analysis, risk ratios (RRs) were calculated and pooled using a random effects model. The secondary outcome was post-procedural complication rates. RESULTS: Six studies with a total of 1335 lesions were included in the meta-analysis. The techniques performed in the intervention group targeting the resection margin were argon plasma coagulation, snare tip soft coagulation, extended EMR, and precutting EMR. The interventions reduced the adenoma recurrence rate with more than 50%, resulting in a pooled RR of 0.37 (95% CI 0.18, 0.76) comparing the intervention group with the control groups. Overall post-procedural complication rates did not increase significantly in the intervention arm (RR 1.30; 95% CI 0.65, 2.58). CONCLUSION: Interventions targeting the EMR margin decrease recurrence rates and may not result in more complications.

Clip placement to prevent delayed bleeding after colonic endoscopic mucosal resection (CLIPPER): study protocol for a randomized controlled trial.

BACKGROUND: Endoscopic mucosal resection (EMR) for large colorectal polyps is in most cases the preferred treatment to prevent progression to colorectal carcinoma. The most common complication after EMR is delayed bleeding, occurring in 7% overall and in approximately 10% of polyps ≥ 2 cm in the proximal colon. Previous research has suggested that prophylactic clipping of the mucosal defect after EMR may reduce the incidence of delayed bleeding in polyps with a high bleeding risk. METHODS: The CLIPPER trial is a multicenter, parallel-group, single blinded, randomized controlled superiority study. A total of 356 patients undergoing EMR for large (≥ 2 cm) non-pedunculated polyps in the proximal colon will be included and randomized to the clip group or the control group. Prophylactic clipping will be performed in the intervention group to close the resection defect after the EMR with a distance of < 1 cm between the clips. Primary outcome is delayed bleeding within 30 days after EMR. Secondary outcomes are recurrent or residual polyps and clip artifacts during surveillance colonoscopy after 6 months, as well as cost-effectiveness of prophylactic clipping and severity of delayed bleeding. DISCUSSION: The CLIPPER trial is a pragmatic study performed in the Netherlands and is powered to determine the real-time efficacy and cost-effectiveness of prophylactic clipping after EMR of proximal colon polyps ≥ 2 cm in the Netherlands. This study will also generate new data on the achievability of complete closure and the effects of clip placement on scar surveillance after EMR, in order to further promote the debate on the role of prophylactic clipping in everyday clinical practice. TRIAL REGISTRATION: ClinicalTrials.gov NCT03309683 . Registered on 13 October 2017. Start recruitment: 05 March 2018. Planned completion of recruitment: 31 August 2021.

Factors involved in endoscopists' choice for prophylactic clipping after colorectal endoscopic mucosal resection: a discrete choice experiment.

Background: Delayed bleeding (DB) occurs in ∼10% after colorectal EMR. Prophylactic clipping (PC) was reported to significantly decrease DB-rate in proximal lesions ≥2 cm.Objective: Our aim was to determine which predefined variables contribute to using PC in clinical practice.Methods: We performed an international discrete choice experiment (DCE) among ∼500 endoscopists. Relevant variables for PC use were selected by EMR experts: previous DB, anticoagulants, polyp size, morphology, location, intraprocedural bleeding and visible vessel(s). Respondents answered case scenarios with various variable combinations, each time choosing only one scenario for PC, or the 'none' option. Part-worth utilities and importance weights were calculated using HB regression. Subsequently, a predictive model was created to calculate the likelihood of endoscopists choosing PC in any given case.Results: The survey was completed by 190 EMR endoscopists from 17 countries. In total, 8% would never use PC, whereas 30.9% never chose the 'none' option. All variables except polyp type were significant in decision-making for PC (p < .01). The most important factor was anticoagulant use, accounting for 22.5% in decision-making. Polyps <2 cm were considered eligible for PC by 14% in the presence of high-weighing factors such as anticoagulant use. No significant differences were found between high and low-to-moderately experienced endoscopists.Conclusions: PC after EMR is often considered useful by endoscopists, usually based on risk factors for DB. Anticoagulant use was the most important factor in decision-making for PC, independent of endoscopist experience. Although not considered cost-effective, one in seven endoscopists chose PC for adenomas <2 cm.