Comparative Study of Three Common Bile Duct Closure Techniques

NCT ID: NCT04264299

Last Updated: 2021-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 211 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2021-04-30

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

T tube drainage

Closure of common bile duct after choledocholithotomy over T tube

Group Type: ACTIVE_COMPARATOR

Primary closure

Intervention Type: PROCEDURE

Primary closure of common bile duct

Antegrade stenting

Intervention Type: PROCEDURE

Closure of common bile duct over antegrade plastic biliary stent

Primary closure

Primary closure of the common bile duct after choledocholithotomy

Group Type: EXPERIMENTAL

T tube drainage

Intervention Type: PROCEDURE

closure of common bile duct over T tube

Antegrade stenting

Intervention Type: PROCEDURE

Closure of common bile duct over antegrade plastic biliary stent

Antegrade stenting

Closure of common bile duct over antegrade biliary plastic stent

Group Type: EXPERIMENTAL

T tube drainage

Intervention Type: PROCEDURE

closure of common bile duct over T tube

Primary closure

Intervention Type: PROCEDURE

Primary closure of common bile duct

Interventions

T tube drainage

closure of common bile duct over T tube

Intervention Type: PROCEDURE

Primary closure

Primary closure of common bile duct

Intervention Type: PROCEDURE

Antegrade stenting

Closure of common bile duct over antegrade plastic biliary stent

Intervention Type: PROCEDURE

Eligibility 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,

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

South Valley University

OTHER

Sponsor Role: lead

Responsible Party

Mohammed Ahmed Omar

Associate professor of HPB surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohammed A. Omar, Ass. Prof.

Role: PRINCIPAL_INVESTIGATOR

South Valley University

Locations

Mohammed Ahmed Omar

Sohag, Qena Governorate, Egypt

Countries

Egypt

References

Omar MA, Redwan AA, Alansary MN. Comparative study of three common bile duct closure techniques after choledocholithotomy: safety and efficacy. Langenbecks Arch Surg. 2022 Aug;407(5):1805-1815. doi: 10.1007/s00423-022-02597-3. Epub 2022 Jul 4.

Reference Type: DERIVED

PMID: 35786738 (View on PubMed)

Other Identifiers

SVU 300

Identifier Type: -

Identifier Source: org_study_id