Early precut sphincterotomy does not increase the risk of adverse events for patients with difficult biliary access A systematic review of randomized clinical trials with meta-analysis and trial sequential analysis

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Abstract
Objective: The present study was conducted to investigate whether early precut sphincterotomy (EPS) itself increases the incidence of post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP), bleeding, and perforation, or improves the overall success rates of biliary cannulation. Methods: Four electronical databases were searched systematically for randomized controlled trials (RCTs) reporting the incidence of adverse events for difficult biliary access (DBA) between EPS groups and persistent cannulation attempts (PCA). The primary endpoint was the incidence of PEP. Secondary outcomes were the incidence of bleeding and perforation, and the overall success rates of biliary cannulation. The Mantel-Haenszel method was used to pool data on the outcomes into random-effect models. Heterogeneity, sensitivity, and stratified analyses were performed with Review Manager 5.3. Furthermore, we performed trial sequential analysis (TSA) to evaluate the reliability of the primary endpoint and secondary outcomes. Results: Seven RCTs (999 patients with DBA of 10450, 9.5%) were included. The incidence of PEP was significantly lower in EPS groups thanPCA(risk ratio [ RR]=0.57, 95% confidence interval [CI] 0.36, 0.92, P = .02). Furthermore, TSA(TSA-adjusted 95% CI 0.30-0.82, P =. 0061) and subgroup analysis stratified by the fellow involvement in initial cannulation before randomization, technique of precut, and the definition of DBA confirmed this finding. Success rates of overall cannulation (RR = 1.00, P = . 94), bleeding (RR = 1.22, P = .58), and perforation (RR = 1.59, P = .32) were similar in both groups; however, the results of TSA could not confirm these findings. Conclusion: Both the quality and the quantity of evidence supporting, compared with PCA, EPS itself do not increase the risk of PEP for DBA patients. Moreover, subgroup analysis demonstrated that EPS can significantly decrease the risk of PEP when it is performed by qualified staff endoscopists with using needle-knife fistulutomy earlier for patients with DBA.

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