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)

Abstract

ObjectiveThe 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.DesignConsecutive 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.ResultsBetween 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).ConclusionEUS-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 numberNCT02212717

2020 World Society of Emergency Surgery updated guidelines for the diagnosis and treatment of acute calculus cholecystitis

“…A recent RCT by Teoh et al [157] identified patients with ACC at very high risk for surgery as patients older than 80 years, with an ASA grade ≥ 3 or an age-adjusted Charlson Comorbidity score > 5 and/or a Karnofsky score < 50. The authors randomized them to receive either EUS-GBD with LAMS or PTGBD within 4 to 6 h from diagnosis.…”

Epidemiology of Gastrointestinal Diseases

“…In patients with acute cholecystitis who are at very-high surgical risk and require an emergent intervention, percutaneous drainage with a cholecystostostomy tube has been the standard of care (Okamoto et al 2018). Recently, endoscopic ultrasound guided gallbladder drainage has gained attention as a potential method of internally draining the gallbladder in high-risk patients, and compared to percutaneous drainage in a randomized trial, it reduced adverse events, re-admissions, unplanned procedures, and recurrent cholecystitis (Teoh et al 2020). Among older patients with choledocholithiasis, cholangitis, and gallstone pancreatitis, endoscopic retrograde cholangiograpancreatography (ERCP) with sphincterotomy and stone extraction is recommended, but follow-up cholecystectomy reduces complications compared to ERCP alone and its benefits outweigh the risk for surgical complications (Elmunzer et al 2017).…”

Safety of EUS-guided gallbladder drainage using a lumen-apposing metal stent in patients requiring anticoagulation

“…[1][2][3] EUS-GBD has emerged as an alternative method of gallbladder decompression, with several studies demonstrating superior outcomes with EUS-GBD when compared with PTGBD. [4][5][6][7][8] As opposed to moreestablished endoscopic procedures, there are no guidelines on the optimal management of anticoagulation in these patients. 7,[9][10][11][12] EUS-GBD is purported to carry a potential reduced risk of bleeding given that the tract to the bowel is less vascular than the liver, the vascular supply of the gallbladder is located along the posterior wall, and the lumen-apposing metal stent (LAMS) routinely used for EUS-GBD may act as a tamponade.…”