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临床试验/NCT07058740
NCT07058740已完成不适用

Safety and Feasibility of Early T-tube Cholangiography Performed Within 2 to 3 Days After LCBDE

Piyou Ji1 个研究点 分布在 1 个国家目标入组 265 人开始时间: 2019年6月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
265
试验地点
1
主要终点
hospital stay

研究概览

简要总结

Current clinical evidence indicates that 10-20% of patients with symptomatic cholelithiasis present with concomitant common bile duct stones (CBDS), a clinical scenario requiring tailored therapeutic approaches. In contemporary surgical practice, laparoscopic common bile duct exploration (LCBDE) combined with T-tube drainage (TTD) has emerged as the intervention of choice for complex biliary pathologies. This approach demonstrates particular efficacy in managing three distinct clinical categories: acute infective conditions such as suppurative cholangitis, structural anomalies including biliary tract injuries and sphincter of Oddi dysfunction, and post-interventional complications spanning biliary strictures, unsuccessful endoscopic retrograde cholangiopancreatography (ERCP) attempts, and significant inflammatory changes in the ductal architecture.

The T-tube serves multiple functions with significant clinical implications. Its primary roles include: (1) enabling intra- and postoperative cholangiography to detect residual stones or clarify biliary anatomy; (2) facilitating bile drainage to reduce ductal pressure and postoperative bile leakage risks; (3) providing a "window" for monitoring biliary secretion, which helps in assessing biliary function and recovery; (4) establishing a sinus tract for secondary stone retrieval, thereby enhancing therapeutic efficacy. T-tubes play a vital role in biliary disease management due to their proven safety and functional advantages in post-LCBDE care.

Postoperative T-tube cholangiography was routinely obtained prior to biliary drainage occlusion to definitively exclude residual choledocholithiasis and confirm contrast agent passage into the duodenum in patients undergoing LCBDE with TTD. While T-tube cholangiography provides crucial postoperative evaluation, it may also lead to complications such as abdominal pain, fever, diarrhea, and bile leakage around the T-tube. The smooth flow of contrast agent into the duodenum during cholangiography is a key criterion for determining whether the T-tube can be clamped. Once this condition is met, the T-tube can be closed, and the drainage bag removed, minimizing the impact on daily activities and marking a significant phase in postoperative recovery.

The timing of T-tube cholangiography directly affects the duration of drainage bag use, but there is no consensus on the earliest timing in clinical practice. Most studies recommend performing cholangiography at least 5 days postoperatively. Zhang et al. reported performing cholangiography 5 days postoperatively, while four other studies consistently chose 7 days postoperatively. Additionally, K. S. Gurusamy suggest performing cholangiography 10 to 14 days postoperatively. The earliest timing for postoperative T-tube cholangiography remains unclear and requires further research to guide clinical practice.

To evaluate the safety and feasibility of early post-LCBDE T-tube cholangiography (2-3days), this retrospective cohort study compared patients receiving biliary imaging within the early window (≤3days) versus those undergoing delayed protocol (>3days postoperatively).Furthermore, the data from patients who underwent cholangiography within 2-3 days were compared with data from other studies to assess the clinical outcomes and potential complications of early T-tube cholangiography, aiming to optimize postoperative management strategies.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • 1.Confirmed diagnosis of CBDS; 2.LCBDE with T-tube placement; 3.Postoperative T-tube cholangiography.

排除标准

  • 1.Incomplete data; 2.Animal or non-human studies; 3.Case reports or single-case studies.

结局指标

主要结局

hospital stay

时间窗: From enrollment to the end of treatment at 2 weeks

patients stay in hospital after operations

complications

时间窗: From enrollment to the end of treatment at 4 weeks

bile leak and pancreatitis

次要结局

未报告次要终点

研究者

发起方
Piyou Ji
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Piyou Ji

associate chief physician

Yantai Affiliated Hospital of Binzhou Medical University

研究点 (1)

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