Comparative Study of Three Common Bile Duct Closure Techniques

South Valley University

Status: Completed

Conditions: Common Bile Duct Closure

Treatments: Procedure: Primary closure; Procedure: Antegrade stenting; Procedure: T tube drainage

Study type: Interventional

Funder types: Other

Identifiers

NCT04264299

SVU 300

Details and patient eligibility

About

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.

Full 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.

Enrollment: 211 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

• CBD stones
• age from 20 to 80,
• CBD > 0.8 cm and < 2.5 cm,
• American Society of Anesthesiologists (ASA) grade I, II or III,
• agreement to randomization and complete the study requirement. Exclusion criteria
• acute suppurative cholangitis,
• acute biliary pancreatitis,
• biliary malignancy,
• biliary malformation,
• distal CBD stenosis and or obstruction,
• trans-cystic stone extraction,
• explorations followed by choledochojejunostomy and choledochoduodenostomy.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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211 participants in 3 patient groups

T tube drainage

Active Comparator group

Description:

Closure of common bile duct after choledocholithotomy over T tube

Treatment:

Procedure: Primary closure

Procedure: Antegrade stenting

Primary closure

Experimental group

Description:

Primary closure of the common bile duct after choledocholithotomy

Treatment:

Procedure: Antegrade stenting

Procedure: T tube drainage

Antegrade stenting

Experimental group

Description:

Closure of common bile duct over antegrade biliary plastic stent

Treatment:

Procedure: Primary closure

Procedure: T tube drainage