The Evaluation of ENGBD Versus PTGBD in High Risk Acute Cholecystitis: A Single-Center Prospective Randomized Controlled Trial

Background: Gallbladder drainage plays a key role in the management of high-risk patients with acute cholecystitis. Percutaneous transhepatic gallbladder drainage (PTGBD) is a common drainage method, and endoscopic naso-gallbladder drainage (ENGBD) is an alternative natural orifice transluminal endoscopic procedure. No study has clearly declared the better method or their impact on subsequent cholecystectomy. Methods: We performed an open-label, prospective randomized controlled parallel trial at a tertiary surgical center. Patients who needed gallbladder decompression were randomly assigned to receive ENGBD or PTGBD. The primary endpoint was the abdominal pain score, and the intention-to-treat population was analyzed. Findings: Twenty-two participants were enrolled, and the abdominal pain scores of the ENGBD group before drainage and 24, 48, and 72 hours after drainage were 6.0 (6.0-8.0), 4.0 (3.0-6.0), 2.0 (2.0-2.0) and 1.0 (1.0-2.0), respectively, while those of the PTGBD group were 7.0 (6.0-9.0), 6.0 (6.0-7.0), 5.0 (4.0-6.0) and 3.0 (3.0-5.0), respectively. The abdominal pain scores were significantly lower in the ENGBD group, as were the gallbladder area tenderness score(P <0.05). ENGBD was associated with significantly fewer hemorrhages and abdominal drainage tubes than PTGBD (15 [5-20] vs 40 [20-70] ml, 3 vs 9, P <0.05), and a significant difference in the grade and lymphocyte count of gallbladder pathology was observed (P <0.05). Interpretation: ENGBD and PTGBD were equivalent in terms of technical success, clinical effectiveness, and safety. ENGBD was associated with less pain, certain advantages in gallbladder pathology and fewer difficulties from cholecystectomy. Trial Registration Number: Registered at http://www.clinicaltrial.gov under trial identification number NCT03701464. Funding: This work was supported by National Natural Science Foundation of China (NO.31570509). There was no commercial support. Conflict of Interest: No conflict of interest was declared by the authors. Ethical Approval: The ethics committee of the hospital center approved the study, which was performed in accordance with a published protocol.