Safety and Feasibility of Early T-tube Cholangiography Performed Within 2 to 3 Days After Laparoscopic Common Bile Duct Exploration

NCT07058740 | Completed

• 1 other identifier: F-KY-0022-20220325-01
• Study Type: interventional
• Target: 265
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Common Bile Duct Calculi; Laparoscopic Abdominal Surgery; Cholangiography

Outcome Measures

Primary Outcomes (2)

• hospital stay

  patients stay in hospital after operations

  From enrollment to the end of treatment at 2 weeks

• complications

  bile leak and pancreatitis

  From enrollment to the end of treatment at 4 weeks

Study Arms (2)

early cholangiography group

EXPERIMENTAL

T-tube cholangiography performed 2-3 days postoperatively

Procedure: early cholangiography

delayed cholangiography group

NO INTERVENTION

T-tube cholangiography performed \>3 days postoperatively

Interventions

early cholangiography PROCEDURE

We perform cholangiography on the early group in advance

early cholangiography group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Piyou Ji: lead

Study Sites (1)

Yantai affiliated hospital of Binzhou Medical University

Yantai, Shandong, 264100, China

Location

MeSH Terms

Conditions

Gallstones

Condition Hierarchy (Ancestors)

Cholelithiasis; Biliary Tract Diseases; Digestive System Diseases; Cholecystolithiasis; Gallbladder Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: associate chief physician

Study Record Dates

• First Submitted: June 30, 2025
• First Posted: July 10, 2025
• Study Start: June 1, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: July 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)