BACKGROUND & AIMS:Endoscopic ultrasound-guided transmural gallbladder drainage (EUS-GBD) is an alternative to percutaneous transhepatic gallbladder drainage (PTGBD) for patients with acute, high-risk, or advanced-stage cholecystitis who do not respond to initial medical treatment and cannot undergo emergency cholecystectomy. However, the technical feasibility, efficacy, and safety of EUS-GBD and PTGBD have not been compared. METHODS:Fifty-nine patients with acute cholecystitis, who did not respond to initial medical treatment and were unsuitable for an emergency cholecystectomy, were chosen randomly to undergo EUS-GBD (n = 30) or PTGBD (n = 29). The technical feasibility, efficacy, and safety of EUS-GBD and PTGBD were compared. RESULTS:EUS-GBD and PTGBD showed similar technical (97% [29 of 30] vs 97% [28 of 29]; 95% 1-sided confidence interval lower limit, -7%; P = .001 for noninferiority margin of 15%) and clinical (100% [29 of 29] vs 96% [27 of 28]; 95% 1-sided confidence interval lower limit, -2%; P = .0001 for noninferiority margin of 15%) success rates, and similar rates of complications (7% [2 of 30] vs 3% [1 of 29]; P = .492 in the Fisher exact test) and conversions to open cholecystectomy (9% [2 of 23] vs 12% [3 of 26]; P = .999 in the Fisher exact test). The median post-procedure pain score was significantly lower after EUS-GBD than after PTGBD (1 vs 5; P < .001 in the Mann-Whitney U test). CONCLUSIONS:EUS-GBD is comparable with PTGBD in terms of the technical feasibility and efficacy; there were no statistical differences in the safety. EUS-GBD is a good alternative for high-risk patients with acute cholecystitis who cannot undergo an emergency cholecystectomy.
RCT Entities:
BACKGROUND & AIMS: Endoscopic ultrasound-guided transmural gallbladder drainage (EUS-GBD) is an alternative to percutaneous transhepatic gallbladder drainage (PTGBD) for patients with acute, high-risk, or advanced-stage cholecystitis who do not respond to initial medical treatment and cannot undergo emergency cholecystectomy. However, the technical feasibility, efficacy, and safety of EUS-GBD and PTGBD have not been compared. METHODS: Fifty-nine patients with acute cholecystitis, who did not respond to initial medical treatment and were unsuitable for an emergency cholecystectomy, were chosen randomly to undergo EUS-GBD (n = 30) or PTGBD (n = 29). The technical feasibility, efficacy, and safety of EUS-GBD and PTGBD were compared. RESULTS: EUS-GBD and PTGBD showed similar technical (97% [29 of 30] vs 97% [28 of 29]; 95% 1-sided confidence interval lower limit, -7%; P = .001 for noninferiority margin of 15%) and clinical (100% [29 of 29] vs 96% [27 of 28]; 95% 1-sided confidence interval lower limit, -2%; P = .0001 for noninferiority margin of 15%) success rates, and similar rates of complications (7% [2 of 30] vs 3% [1 of 29]; P = .492 in the Fisher exact test) and conversions to open cholecystectomy (9% [2 of 23] vs 12% [3 of 26]; P = .999 in the Fisher exact test). The median post-procedure pain score was significantly lower after EUS-GBD than after PTGBD (1 vs 5; P < .001 in the Mann-Whitney U test). CONCLUSIONS: EUS-GBD is comparable with PTGBD in terms of the technical feasibility and efficacy; there were no statistical differences in the safety. EUS-GBD is a good alternative for high-risk patients with acute cholecystitis who cannot undergo an emergency cholecystectomy.
Authors: Hugo Gonçalo Guedes; Roberto Iglesias Lopes; Joel Fernandez de Oliveira; Everson Luiz de Almeida Artifon Journal: World J Gastrointest Endosc Date: 2015-10-25
Authors: Ola Ahmed; Ailin C Rogers; Jarlath C Bolger; Achille Mastrosimone; Michael J Lee; Aoife N Keeling; Daniel Cheriyan; William B Robb Journal: Surg Endosc Date: 2018-02-05 Impact factor: 4.584