Modified Continuous Versus Interrupted Choledochotomy Closure in LCBDE With T-Tube Drainage

Yantai Affiliated Hospital of Binzhou Medical University

Status: Completed

Conditions: Common Bile Duct Calculi

Treatments: Procedure: Modified continuous suture; Procedure: Interrupted suture

Study type: Observational

Funder types: Other

Identifiers

NCT07345663

LW-202601

F-KY-0022-20220325-01

Details and patient eligibility

About

This observational study aims to compare two techniques for closing the common bile duct incision (choledochotomy) after laparoscopic common bile duct exploration (LCBDE) with T-tube drainage. Interrupted suturing is commonly used, but it can be time-consuming during laparoscopic surgery. A modified continuous suturing approach may improve efficiency while maintaining safety.

We will retrospectively review patients who underwent LCBDE with T-tube drainage at our institution. Patients will be grouped according to the choledochotomy closure technique used during routine clinical care (modified continuous suturing versus conventional interrupted closure). To reduce baseline differences between groups, propensity score matching based on preoperative and intraoperative characteristics will be applied.

The primary outcome is choledochotomy closure time. Secondary outcomes include total operative time and perioperative safety outcomes, such as bile leakage and other postoperative complications, as well as short-term postoperative recovery indicators. This study will provide comparative evidence on operative efficiency and safety of continuous versus interrupted choledochotomy closure in the setting of LCBDE with T-tube drainage.

Enrollment: 360 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• (1) age ≥18 years; (2) imaging-confirmed CBDS; (3) intraoperative placement of a T-tube; and (4) Common bile duct (CBD) diameter ≥6 mm

Exclusion criteria

• coagulopathy, severe cognitive impairment, multiple intrahepatic stones, biliary stricture, malignancy, liver cirrhosis, severe acute pancreatitis (BISAP score ≥3), and acute cholangitis complicated by septic shock, classified as Grade III according to the Tokyo Guidelines 2018

Trial design

360 participants in 2 patient groups

Modified Continuous Suturing

Treatment:

Procedure: Modified continuous suture

Interrupted Suturing

Treatment:

Procedure: Interrupted suture