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).

Does periampullary diverticulum affect ERCP cannulation and post-procedure complications? an up-to-date meta-analysis.

Research conclusions differ on the impact of periampullary diverticulum (PAD) on endoscopic retrograde cholangiopancreatography (ERCP). An up-to-date meta-analysis evaluated the role of PAD in ERCP, especially in terms of cannulation failure and early complications. A comprehensive literature search was performed. All statistical analyses were carried out with the Review Manager 5.3 software. Horizontal lines represented a 95% confidence interval (CI) and the area of each square in forest plots. Twenty-six studies including 23 826 patients with or without PAD who underwent ERCP were evaluated. PAD was associated with an increase in the overall cannulation failure rate (RR=1.46, 95% CI: 1.27-1.67; p<.00001), but in the subgroup of studies performed post-2000, PAD was irrelevant to cannulation failure (RR=1.16, 95% CI: 0.96-1.41; p=0.12). In overall analyses, PAD was also associated with a high risk of ERCP-related pancreatitis (RR=1.32, 95% CI: 1.10-1.59; p=0.003), perforation (RR=1.73, 95% CI: 1.06-2.82; p=0.030), and bleeding (RR=1.48, 95% CI: 1.13-1.93; p=0.005). The presence of PAD increased the overall cannulation failure rate, but not the rate post-2000. PAD also affected the occurrence of early pancreatitis, perforation, and bleeding.

Comparison of endoscopic naso-gallbladder drainage and percutaneous transhepatic gallbladder drainage in acute suppurative cholecystitis: Study Protocol Clinical Trial (SPIRIT Compliant).

INTRODUCTION: Transitional drainage, which is followed by cholecystectomy plays a key role in the management of acute cholecystitis, especially in high-risk surgical patients. Endoscopic naso-gallbladder drainage (ENGBD) is an alternative to percutaneous transhepatic gallbladder drainage (PTGBD) for patients who need temporary drainage. There is a lack of prospective comparison on the relevant outcomes of the two drainage methods during the period of drainage, especially the subsequent cholecystectomy. METHODS: This is a randomized controlled two-arm non-blind single center trial. Patients with acute cholecystitis undergo emergent or early cholecystectomy and need drainage will be randomly assigned to group PTGBD or ENGBD. Pain score is defined as the primary endpoint, whereas several secondary endpoints, such as the rates of technical success, clinical remission, open conversion of cholecystectomy will be determined to elucidate more detailed differences between two groups. The general feasibility, safety, and quality checks required for high-quality evidence will be adhered to. DISCUSSION: This study would provide the first type A evidence concerning the comparison of ENGBD versus PTGBD in surgically high-risk patients with acute cholecystitis, it will be the first trial designed to determine the impact of two drainage methods on not only peri-drainage but also peri-LC. TRIAL REGISTRATION: NCT03701464. Registered on October 10, 2018.