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内镜下胆囊支架置入预防延期胆囊切除术后胆囊炎复发的随机试验。

Endoscopic Gallbladder Stenting to Prevent Recurrent Cholecystitis in Deferred Cholecystectomy: A Randomized Trial.

机构信息

Division of Gastroenterology, Department of Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand; Excellence Center for Gastrointestinal Endoscopy, King Chulalongkorn Memorial Hospital, Bangkok, Thailand.

Department of Surgery, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.

出版信息

Gastroenterology. 2024 Jun;166(6):1145-1155. doi: 10.1053/j.gastro.2024.02.007. Epub 2024 Feb 14.

DOI:10.1053/j.gastro.2024.02.007
PMID:38360274
Abstract

BACKGROUND & AIMS: Endoscopic transpapillary gallbladder stenting (ETGS) has been proposed as one of the adjunctive treatments, apart from antibiotics, before surgery in patients with acute cholecystitis whose cholecystectomy could not be performed or was deferred. Currently, there are no comparative data on the outcomes of ETGS in those who receive and do not receive ETGS. We aimed to compare the rates of recurrent cholecystitis at 3 and 6 months in these 2 groups.

METHODS

Between 2020 and 2023, eligible acute calculous cholecystitis patients with a high probability of common bile duct stone, who were surgical candidates but could not have an early cholecystectomy during COVID-19 surgical lockdown, were randomized into groups A (received ETGS) and B (did not receive ETGS). A definitive cholecystectomy was performed at 3 months or later in both groups.

RESULTS

A total of 120 eligible patients were randomized into group A (n = 60) and group B (n = 60). In group A, technical and clinical success rates were 90% (54 of 60) and 100% (54 of 54), respectively. Based on intention-to-treat analysis, group A had a significantly lower rate of recurrence than group B at 3 months (0% [0 of 60] vs 18.3% [11 of 60]; P = .001). At 3-6 months, group A showed a nonsignificantly lower rate of recurrent cholecystitis compared to group B (0% [0 of 32] vs 10% [3 of 30]; P = .11).

CONCLUSIONS

ETGS could prevent recurrent cholecystitis in acute cholecystitis patients with common bile duct stone whose cholecystectomy was deferred for 3 months. In those who did not receive ETGS, the majority of recurrences occurred within 3 months. (Thaiclinicaltrials.org, Number TCTR20200913001).

摘要

背景与目的

内镜经乳头胆囊支架置入术(ETGS)已被提议作为除抗生素以外的辅助治疗方法之一,适用于那些因急性胆囊炎而无法进行或推迟胆囊切除术的患者。目前,尚无关于接受和不接受 ETGS 的患者在 ETGS 后 3 个月和 6 个月时复发性胆囊炎发生率的比较数据。本研究旨在比较这两组患者在 3 个月和 6 个月时复发性胆囊炎的发生率。

方法

2020 年至 2023 年期间,纳入了有高概率存在胆总管结石的急性结石性胆囊炎患者,这些患者为手术候选者,但在 COVID-19 手术封锁期间无法进行早期胆囊切除术。这些患者被随机分为 A 组(接受 ETGS)和 B 组(未接受 ETGS)。两组患者均在 3 个月后或更晚进行确定性胆囊切除术。

结果

共纳入 120 例符合条件的患者,随机分为 A 组(n=60)和 B 组(n=60)。在 A 组中,技术成功率和临床成功率分别为 90%(54/60)和 100%(54/54)。基于意向治疗分析,A 组在 3 个月时的复发率明显低于 B 组(0%[0/60] vs 18.3%[11/60];P=0.001)。在 3 个月至 6 个月时,A 组的复发性胆囊炎发生率与 B 组相比虽无统计学意义,但呈下降趋势(0%[0/32] vs 10%[3/30];P=0.11)。

结论

ETGS 可预防胆总管结石且胆囊切除术延迟 3 个月的急性胆囊炎患者的复发性胆囊炎。在未接受 ETGS 的患者中,大多数复发发生在 3 个月内。(泰国临床试验注册中心,注册号 TCTR20200913001)。

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