NCT04264299

Comparative Study of Three Common Bile Duct Closure Techniques

Comparative Study of Three Common Bile Duct Closure Techniques After Choledocholithotomy: Safety and Efficacy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 211 (actual)
• Sponsor: South Valley University · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Accepted

Summary

This study evaluates the efficacy and safety of three different methods of CBD repair after common bile duct exploration and provides more evidence for selecting the optimal duct closure after choledocholithotomy.

Detailed description

At present, the commonest available options for CBD closure include repair over T-tube drain, primary closure, and repair after antegrade biliary stenting. All three methods present specific technical performance features, require different postoperative management protocols, and are charged with specific morbidity related to the procedure and therefore should not be considered the same procedure in the context of CBDE. Repair over T-tube is the traditional surgical technique. It has many advantages as post-operative distal CBD decompression, trans-tubal cholangiography, and availability of retained CBD stones extraction. However, it has several potential complications up to 10% of patients. The most frequent complications are bile leakage, tract infection, T-tube dislodgement, electrolyte and nutritional disturbances, cholangitis, or acute renal failure from dehydration due to inadequate water ingestion. It also causes discomfort and persistent pain to the patient along with increased hospital admission and thus the economic burden to the country. Primary closure of CBD has been described in the literature to overcome these adverse consequences of the T-tube. However, it has many potential complications as a potential bile leak and CBD stricture, which may occur due to papillary edema and insufficient bile duct expansion. There are conflicting results regarding significant differences in the morbidity and mortality between primary closure and T-tube drainage. There is no conclusive evidence displaying whether primary closure is better or worse than T-tube drainage after CBD exploration. Using a biliary stent in primary closure is an effective method to decrease the two complications, which can reduce biliary pressure without bile loss. Although there are some available drainage options after CBDE, a consensus on the optimal drainage is yet to be reached.

Conditions

• Common Bile Duct Closure

Interventions

Type	Name	Description
PROCEDURE	T tube drainage	closure of common bile duct over T tube
PROCEDURE	Primary closure	Primary closure of common bile duct
PROCEDURE	Antegrade stenting	Closure of common bile duct over antegrade plastic biliary stent

Timeline

• Start date: 2017-01-01
• Primary completion: 2020-01-01
• Completion: 2021-04-30
• First posted: 2020-02-11
• Last updated: 2021-05-11

Locations

1 site across 1 country: Egypt