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胆总管探查术后自膨式胆道支架置入与直接一期缝合的随机对照试验:降低胆漏风险的新选择。

Randomized controlled trial of primary closure after common bile duct exploration with self-detachable biliary stent placement versus direct primary closure: A new alternative to reduce bile leakage risk.

作者信息

Zhou Huabo, He Yijia, Sun Ke

机构信息

Department of Hepatobiliary and Pancreatic Surgery, Chengdu Second People's Hospital, Sichuan, Chengdu, China.

Department of Hepatobiliary and Pancreatic Surgery, Chengdu Second People's Hospital, Sichuan, Chengdu, China. Electronic address: https://twitter.com/Yijiasimn.

出版信息

Surgery. 2025 Sep;185:109506. doi: 10.1016/j.surg.2025.109506. Epub 2025 Jun 20.

DOI:10.1016/j.surg.2025.109506
PMID:40543448
Abstract

BACKGROUND

Bile leakage is the most common complication after laparoscopic common bile duct exploration. This study explores the clinical efficacy of using a 5-F biliary stent with automatic detachment to prevent bile leakage postbiliary exploration.

METHODS

This randomized controlled observational study was conducted from January 2023 to January 2025. Patients undergoing primary closure of the common bile duct in our team were randomly divided into 2 groups. The treatment group had biliary stents placed during biliary stone extraction and then primary closure, whereas the control group had direct primary closure after stone extraction. The primary outcome was bile leakage incidence. The secondary outcome measure was the rate of automatic removal of biliary stents, surgical time, postoperative hospital stay, postoperative blood test indicators, and complications.

RESULTS

Both groups included 85 patients. Preoperative data such as white blood cell count, aspartate transaminase, alanine aminotransferase, total bilirubin, direct bilirubin, albumin, serum amylase, serum lipase, common bile duct diameter, and stone characteristics were comparable (P > .05). In the treatment group, stent placement took 8 (5-12) minutes. All stents were in place at 72 hours post operatively. The automatic detachment rate at 1 month was 98.93%, with 1 case removed via duodenoscopy. The bile leakage rate (1.17% vs 9.41%), surgical time (103.11 ± 10.16 minutes vs 99.89 ± 9.07 minutes), and postoperative hospital stay (4.56 ± 0.69 days vs 5.09 ± 0.84 days) were significantly different between the groups (P < .05). There were no significant differences in postoperative 48-hour blood indicators (P > .05), but total bilirubin, direct bilirubin, and alanine aminotransferase decreased significantly compared with preoperative levels in both groups.

CONCLUSION

Placing a 5-F biliary stent with automatic detachment during laparoscopic common bile duct exploration for stone extraction and then performing primary closure can effectively reduce bile leakage and postoperative hospital stay. With a short placement time and high automatic detachment rate, this method is simple and worthy of promotion.

摘要

背景

胆漏是腹腔镜胆总管探查术后最常见的并发症。本研究探讨使用5-F自动脱落胆道支架预防胆道探查术后胆漏的临床疗效。

方法

本随机对照观察性研究于2023年1月至2025年1月进行。在我们团队中接受胆总管一期缝合的患者被随机分为两组。治疗组在取石时放置胆道支架,然后进行一期缝合,而对照组在取石后直接进行一期缝合。主要结局是胆漏发生率。次要结局指标是胆道支架自动脱落率、手术时间、术后住院时间、术后血液检查指标和并发症。

结果

两组各纳入85例患者。术前白细胞计数、天冬氨酸转氨酶、丙氨酸转氨酶、总胆红素、直接胆红素、白蛋白、血清淀粉酶、血清脂肪酶、胆总管直径和结石特征等数据具有可比性(P>.05)。治疗组放置支架用时8(5-12)分钟。术后72小时所有支架均在位。1个月时自动脱落率为98.93%,1例经十二指肠镜取出。两组间胆漏率(1.17%对9.41%)、手术时间(103.11±10.16分钟对99.89±9.07分钟)和术后住院时间(4.56±0.69天对5.09±0.84天)差异有统计学意义(P<.05)。术后48小时血液指标差异无统计学意义(P>.05),但两组总胆红素、直接胆红素和丙氨酸转氨酶较术前均显著下降。

结论

在腹腔镜胆总管探查取石时放置5-F自动脱落胆道支架,然后进行一期缝合,可有效减少胆漏和术后住院时间。该方法放置时间短、自动脱落率高,操作简单,值得推广。

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