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

Modified Continuous Versus Interrupted Choledochotomy Closure in LCBDE With T-Tube Drainage: A Propensity Score-Matched Cohort Study

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.

Study Overview

• Status: Completed
• Conditions: Common Bile Duct Calculi
• Intervention / Treatment: Procedure: Modified continuous suture; Procedure: Interrupted suture

• Study Type: Observational
• Enrollment (Actual): 360

Contacts and Locations

Study Locations

• China
  • Shandong
    • Yantai, Shandong, China, 264100
      • Yantai Affiliated Hospital of Binzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population consists of patients who underwent laparoscopic common bile duct exploration (LCBDE) with T-tube drainage at our institution between January 2020 and November 2024. Inclusion criteria include patients who had choledochotomy closure performed with either modified continuous suturing (MCS) or interrupted suturing (IS). Patients were retrospectively reviewed, and baseline characteristics such as age, gender, stone burden, and ASA classification were collected. Exclusion criteria include patients with incomplete data or those who underwent procedures other than LCBDE.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Modified Continuous Suturing	Procedure: 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.
Interrupted Suturing	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Choledochotomy Closure Time	The time taken to complete choledochotomy closure, from the beginning of suturing to the completion of the final knot. This measure is recorded in minutes for each patient.	Closure time is measured intraoperatively during the procedure and recorded once closure is complete.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Operative Time	The total time from the initiation of the procedure to the completion of the surgery. This includes all steps of the surgery, from incision to closure.	The total operative time is measured during the procedure, from the first incision to the final closure.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative Blood Loss	The total estimated blood loss during the surgery, as measured by the surgeon and recorded at the end of the procedure. This is typically recorded in milliliters.	Blood loss is recorded intraoperatively at the end of the surgery, based on visual estimation and suction collection.

Collaborators and Investigators

• Sponsor: Yantai Affiliated Hospital of Binzhou Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): November 30, 2024
• Study Completion (Actual): December 31, 2025

Study Registration Dates

• First Submitted: January 7, 2026
• First Submitted That Met QC Criteria: January 7, 2026
• First Posted (Estimated): January 16, 2026

Study Record Updates

• Last Update Posted (Estimated): January 16, 2026
• Last Update Submitted That Met QC Criteria: January 7, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Calculi; Pathological Conditions, Anatomical; Digestive System Diseases; Biliary Tract Diseases; Gallbladder Diseases; Cholelithiasis; Cholecystolithiasis; Pathological Conditions, Signs and Symptoms; Gallstones
• Other Study ID Numbers: LW-202601; F-KY-0022-20220325-01 (Other Identifier: Yantai affiliated hospital of Binzhou Medical University)