Endosonography-Guided Gallbladder Drainage versus Percutaneous Cholecystostomy in Patients Suffering from Acute Cholecystitis That Are Unsuitable for Surgery. A Randomized Controlled Trial (DRAC)

Abstract

Background: 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 EUS-guided gallbladder drainage (EUS-GBD) to percutaneous cholecystostomy (PT-GBD) as a definitive treatment in these patients under a randomized controlled trial. Methods: 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. Findings: 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 = 0.001], re-interventions after 30-days [1/39 (2.6%) vs 8/40 (30%), P = 0.001], number of unplanned readmissions [6/39 (6%) vs 20/40 (50%), P = 0.002] and recurrent cholecystitis [1/39 (2.6%) vs 8/40 (20%), P = 0.029]. Post-procedural 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 predictors to recurrent acute cholecystitis were ASA grading ≥ 3 (P = 0.025) and performance of PT-GBD (P = 0.032). Interpretation: EUS-GBD improved outcomes as compared to PT-GBD in those at very high-risk of cholecystectomy. EUS-GBD should be the procedure of choice provided that the expertise is available. Clinical Registration No.: Clinicaltrials.gov identified: NCT02212717. Funding Statement: study was supported by the American Society of Gastrointestinal Endoscopy research awards. Declaration of Interests: Prof. Anthony Y.B. Teoh is also a consultant for Boston Scientific, Cook, Taewoong and Microtech Medical Corporations. Other co-authors do not have any conflicts of interest to disclose. Ethical Approval Statement: The study was conducted according to the Declaration of Helsinki and the International Conference on Harmonisation, good clinical practice guidelines (ICH-GCP). This study was approved by the Joint-CUHK-NTEC Research Ethic Committee.