Background: There are currently no prospective, controlled trials of endoscopic transpapillary gallbladder drainage in patients with acute cholecystitis.
Objective: We evaluated the technical success rate and efficacy of endoscopic transpapillary gallbladder drainage by using either endoscopic nasogallbladder drainage (ENGBD) or endoscopic gallbladder stenting (EGBS) for patients with acute cholecystitis.
Design: Randomized, controlled study.
Setting: Tertiary-care referral centers.
Patients: Seventy-three consecutive patients with acute cholecystitis were randomized.
Interventions: ENGBD by using a 5F or 7F tube (n = 37) or EGBS (n = 36) by using a 7F stent.
Main Outcome And Measurements: Technical success, clinical success, adverse events, and procedure-related pain score.
Results: The overall technical success rates in the ENGBD and EGBS groups were 91.9% and 86.1%, respectively (P > .05). The mean procedure times of ENGBD and EGBS were 20.3 ± 12.1 and 22.2 ± 14.5 minutes, respectively (P > .05). The overall clinical success rates by per protocol analysis were 94.1% and 90.3% in the ENGBD and EGBS groups, respectively, whereas the rates by intention-to-treat analysis were 86.5% and 77.8%, respectively (P > .05). Moderate adverse events were observed in the ENGBD (n = 2) and EGBS (n = 1) groups. The mean visual analog score of postprocedure pain in the ENGBD group was significantly higher than that in the EGBS group (1.3 ± 1.1 vs 0.4 ± 0.8, respectively; P < .001).
Limitations: Small sample size and the participation of multiple endoscopists who may have different levels of experience in endoscopic transpapillary gallbladder drainage.
Conclusions: Both ENGBD and EGBS appear to be suitable for the treatment of acute cholecystitis in patients who are poor candidates for emergency cholecystectomy. (
Clinical Trial Registration Number: UMIN000012316.).
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