Trial sequential analysis of EUS-guided gallbladder drainage versus percutaneous cholecystostomy in patients with acute cholecystitis.

BACKGROUND AND AIMS: Meta-analytic comparison of EUS-guided gallbladder drainage (EUS-GBD) versus percutaneous gallbladder drainage (PT-GBD) for acute cholecystitis (AC) brings the risk of spurious results if too few studies are included. Trial sequential analysis (TSA) can overcome this, providing information about its credibility.

METHODS

Comparative studies between EUS-GBD, using lumen-apposing metal stents, and PT-GBD for AC until July 2021 were used for conventional meta-analysis and TSA, which allowed the use of monitoring boundaries and the estimation of the required information size (RIS) needed to prove credibility.

RESULTS

Four studies accrued 535 patients. Technical success was in favor of PT-GBD (relative risk [RR], .967; P = .036), but TSA estimated that 1663 participants would be needed to avoid a Type I error (false positive). Clinical success was similar (RR, .965; P = .146), and TSA supported the absence of any demonstrable superiority of one therapy rather than a Type II error (false negative). EUS-GBD reduced overall adverse events (RR, .424; P < .001) and unplanned readmissions (RR, .215; P < .001), and TSA confirmed the avoidance of a Type I error, with early RIS achievement, providing necessary credibility. EUS-GBD had fewer reinterventions (RR, .244; P < .001), but a Type I error was not avoided, needing additional 97 patients to the accrued 535 to prove credibility.

CONCLUSIONS

PT-GBD can provide superior technical success than EUS-GBD if a very large sample size is accrued, thus limiting the single-patient benefit. Clinical success is probably equivalent. EUS-GBD convincingly decreased overall adverse events and unplanned readmissions, whereas the need for reinterventions requires additional studies.