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 acute cholecystitis (AC) patients. Percutaneous transhepatic gallbladder drainage (PTGBD) is commonly used while endoscopic naso-gallbladder drainage (ENGBD) serves as an alternative. METHODS: A single center, prospective randomized controlled trial was performed. Eligible AC patients were randomly assigned to ENGBD or PTGBD group. Randomization was a computer-generated list with 1:1 allocation. All patients received cholecystectomy 2-3 months after drainage. The primary endpoint was abdominal pain score, and the intention-to-treat population was analyzed. (ClinicalTrials.gov: NCT03701464). FINDINGS: Between Oct 1, 2018 and Feb 29, 2020, 22 out of 61 consecutive AC patients were enrolled in the final analysis. The mean abdominal pain scores before drainage, and at 24, 48, and 72 h after drainage in ENGBD were 6.9 ± 1.1, 4.3 ± 1.2, 2.2 ± 0.8 and 1.5 ± 0.5, respectively, while those of PTGBD were 7.4 ± 1.2, 6.2 ± 1.2, 5.3 ± 1.0 and 3.7 ± 0.9; and the mean gallbladder area tenderness scores were 8.4 ± 1.2, 5.7 ± 0.9, 3.5 ± 0.7, 2.5 ± 0.5 for ENGBD and 8.6 ± 0.9, 7.3 ± 1.0, 7.4 ± 0.5, 4.8 ± 0.9 for PTGBD. The mean abdominal pain and gallbladder area tenderness scores of the ENGBD significantly decreased than the PTGBD (group × time interaction P<0.001, respectively). ENGBD group presented lower post-operative hemorrhage and abdominal drainage tube placement rates (median (IQR) 15[5-20] vs 40[20-70]ml, 3vs9, P = 0.03), and pathological grade and lymphocyte count were observed (P = 0.004) between groups. No adverse events were observed in 3 months follow-up. INTERPRETATION: Compared to PTGBD, ENGBD group presented less pain, better gallbladder pathological grades and less surgical difficulties during cholecystectomy procedures. FUNDING: National Natural Science Foundation of China (82060551).