RT Journal Article
SR Electronic
T1 Endosonography-guided gallbladder drainage versus percutaneous cholecystostomy in very high-risk surgical patients with acute cholecystitis: an international randomised multicentre controlled superiority trial (DRAC 1)
JF Gut
JO Gut
FD BMJ Publishing Group Ltd and British Society of Gastroenterology
SP 1085
OP 1091
DO 10.1136/gutjnl-2019-319996
VO 69
IS 6
A1 Teoh, Anthony Y B
A1 Kitano, Masayuki
A1 Itoi, Takao
A1 Pérez-Miranda, Manuel
A1 Ogura, Takeshi
A1 Chan, Shannon Melissa
A1 Serna-Higuera, Carlos
A1 Omoto, Shunsuke
A1 Torres-Yuste, Raul
A1 Tsuichiya, Takayoshi
A1 Wong, Ka Tak
A1 Leung, Chi-Ho
A1 Chiu, Philip Wai Yan
A1 Ng, Enders Kwok Wai
A1 Lau, James Yun Wong
YR 2020
UL http://gut.bmj.com/content/69/6/1085.abstract
AB Objective The optimal management of acute cholecystitis in patients at very high risk for cholecystectomy is uncertain. The aim of the current study was to compare endoscopic ultrasound (EUS)-guided gallbladder drainage (EUS-GBD) to percutaneous cholecystostomy (PT-GBD) as a definitive treatment in these patients under a randomised controlled trial.Design Consecutive patients suffering from acute calculous cholecystitis but were at very high-risk for cholecystectomy were recruited. The primary outcome was the 1-year adverse events rate. Secondary outcomes include technical and clinical success, 30-day adverse events, pain scores, unplanned readmissions, re-interventions and mortalities.Results Between August 2014 to February 2018, 80 patients were recruited. EUS-GBD significantly reduced 1 year adverse events (10 (25.6%) vs 31 (77.5%), p<0.001), 30-day adverse events (5 (12.8%) vs 19 (47.5%), p=0.010), re-interventions after 30 days (1/39 (2.6%) vs 12/40 (30%), p=0.001), number of unplanned readmissions (6/39 (15.4%) vs 20/40 (50%), p=0.002) and recurrent cholecystitis (1/39 (2.6%) vs 8/40 (20%), p=0.029). Postprocedural pain scores and analgesic requirements were also less (p=0.034). The technical success (97.4% vs 100%, p=0.494), clinical success (92.3% vs 92.5%, p=1) and 30-day mortality (7.7% vs 10%, p=1) were statistically similar. The predictor to recurrent acute cholecystitis was the performance of PT-GBD (OR (95% CI)=5.63 (1.20–53.90), p=0.027).Conclusion EUS-GBD improved outcomes as compared to PT-GBD in those patients that not candidates for cholecystectomy. EUS-GBD should be the procedure of choice provided that the expertise is available after a multi-disciplinary meeting. Further studies are required to determine the long-term efficacy.Trial registration number NCT02212717