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

NCT ID: NCT07345663

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 360 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2025-12-31

Brief Summary

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.

Conditions

Common Bile Duct Calculi

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Modified Continuous Suturing

Modified continuous suture

Intervention Type: PROCEDURE

Modified continuous suture was performed using 4-0 knotless barbed polydioxanone sutures (Quill™, Surgical Specialties Corporation). A continuous full-thickness suture was placed from the distal (duodenal) end to the proximal (hepatic) end, with bites of approximately 2 mm and a stitch interval of 3-4 mm. After completion of the continuous closure, 1-2 reinforcing stitches were placed in the opposite direction (from proximal to distal), and the suture was secured by tying to the tail end of the initial stitch.

Interrupted Suturing

Interrupted suture

Intervention Type: PROCEDURE

Interrupted suture was performed using 4-0 antibacterial monofilament polydioxanone sutures (PDS™ Plus, Ethicon, LLC). Interrupted sutures were placed from the distal (duodenal) end to the proximal (hepatic) end, with bites of approximately 2 mm and a stitch interval of 3-4 mm; each stitch was tied separately. An additional 1-2 reinforcing stitches (transverse or figure-of-eight) were placed around the T-tube exit site to enhance apposition between the choledochotomy edge and the tube wall.

Interventions

Modified continuous suture

Modified continuous suture was performed using 4-0 knotless barbed polydioxanone sutures (Quill™, Surgical Specialties Corporation). A continuous full-thickness suture was placed from the distal (duodenal) end to the proximal (hepatic) end, with bites of approximately 2 mm and a stitch interval of 3-4 mm. After completion of the continuous closure, 1-2 reinforcing stitches were placed in the opposite direction (from proximal to distal), and the suture was secured by tying to the tail end of the initial stitch.

Intervention Type: PROCEDURE

Interrupted suture

Interrupted suture was performed using 4-0 antibacterial monofilament polydioxanone sutures (PDS™ Plus, Ethicon, LLC). Interrupted sutures were placed from the distal (duodenal) end to the proximal (hepatic) end, with bites of approximately 2 mm and a stitch interval of 3-4 mm; each stitch was tied separately. An additional 1-2 reinforcing stitches (transverse or figure-of-eight) were placed around the T-tube exit site to enhance apposition between the choledochotomy edge and the tube wall.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yantai Affiliated Hospital of Binzhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

Piyou Ji

associate chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Yantai affiliated hospital of Binzhou Medical University

Yantai, Shandong, China

Countries

China

Other Identifiers

F-KY-0022-20220325-01

Identifier Type: OTHER

Identifier Source: secondary_id

LW-202601

Identifier Type: -

Identifier Source: org_study_id