Trials / Completed
CompletedNCT07058740
Safety and Feasibility of Early T-tube Cholangiography Performed Within 2 to 3 Days After Laparoscopic Common Bile Duct Exploration
Safety and Feasibility of Early T-tube Cholangiography Performed Within 2 to 3 Days After LCBDE
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 265 (actual)
- Sponsor
- Piyou Ji · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | early cholangiography | We perform cholangiography on the early group in advance |
Timeline
- Start date
- 2019-06-01
- Primary completion
- 2023-12-31
- Completion
- 2024-12-31
- First posted
- 2025-07-10
- Last updated
- 2025-07-10
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT07058740. Inclusion in this directory is not an endorsement.