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

NCT ID: NCT07058740

Last Updated: 2025-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 265 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-01
• Study Completion Date: 2024-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

early cholangiography group

T-tube cholangiography performed 2-3 days postoperatively

Group Type: EXPERIMENTAL

early cholangiography

Intervention Type: PROCEDURE

We perform cholangiography on the early group in advance

delayed cholangiography group

T-tube cholangiography performed \>3 days postoperatively

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

early cholangiography

We perform cholangiography on the early group in advance

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Piyou Ji

OTHER

Sponsor Role: lead

Responsible Party

Piyou Ji

associate chief physician

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Yantai affiliated hospital of Binzhou Medical University

Yantai, Shandong, China

Countries

China

Other Identifiers

F-KY-0022-20220325-01

Identifier Type: -

Identifier Source: org_study_id