The evaluation of ENGBD versus PTGBD in high-risk acute cholecystitis: A single-center prospective randomized controlled trial

Peilei Mu, Yanyan Lin, Xianzhuo Zhang, Yawen Lu, Man Yang, Zijian Da, Long Gao, Ningning Mi, Tianya Li, Ying Liu, Haiping Wang, Fang Wang, Joseph W Leung, Ping Yue, Wenbo Meng, Wence Zhou, Xun Li, Peilei Mu, Yanyan Lin, Xianzhuo Zhang, Yawen Lu, Man Yang, Zijian Da, Long Gao, Ningning Mi, Tianya Li, Ying Liu, Haiping Wang, Fang Wang, Joseph W Leung, Ping Yue, Wenbo Meng, Wence Zhou, Xun Li

Abstract

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).

Conflict of interest statement

No conflict of interest was declared by the authors.

© 2020 The Authors.

Figures

Fig. 1
Fig. 1
Flow diagram of the study.
Fig. 2
Fig. 2
ENGBD (a) and PTGBD (b) procedures.
Fig. 3
Fig. 3
Participants' abdominal pain score (a) and gallbladder area tenderness score (b); Y-axes: Data are expressed as the mean ± standard deviation.
Fig. 4
Fig. 4
Lymphocyte count. a–d, pathological results of four patients who received ENGBD (200* field of view); e–h, pathological results of four patients who received ENGBD (400* field of view); i–l, pathological results of four patients who received PTGBD (200* field of view); m–p, pathological results of four patients who received PTGBD (400* field of view).

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Source: PubMed

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