Comparative Study of Three Common Bile Duct Closure Techniques

Not Applicable

Completed

• Conditions: Common Bile Duct Closure
• Interventions: Procedure: Primary closure; Procedure: T tube drainage; Procedure: Antegrade stenting

• Registration Number: NCT04264299
• Lead Sponsor: South Valley University

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.

Study Timeline

• Study Start: 2017-01-01
• Primary Completion: 2020-01-01
• Study First Submitted: 2020-02-07
• Study First Submitted QC: 2020-02-07
• Study First Posted: 2020-02-11
• Study Completion: 2021-04-30
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-07
• Last Update Posted: 2021-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 211

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
T tube drainage	Primary closure	Closure of common bile duct after choledocholithotomy over T tube
Antegrade stenting	T tube drainage	Closure of common bile duct over antegrade biliary plastic stent
T tube drainage	Antegrade stenting	Closure of common bile duct after choledocholithotomy over T tube
Primary closure	T tube drainage	Primary closure of the common bile duct after choledocholithotomy
Primary closure	Antegrade stenting	Primary closure of the common bile duct after choledocholithotomy
Antegrade stenting	Primary closure	Closure of common bile duct over antegrade biliary plastic stent

Primary Outcome Measures

Name	Time	Method
Post operative biliary stricture	6 month	The segmental shrunken of CBD diameter and proximal dilatation by MRCP.
Recurrent biliary stones	6 month	Common bile duct stone after 6 months of the procedure
Postoperative bile leak	3rd to 7th postoperative day	The discharge of fluid via intra-abdominal drain or intra-abdominal fluid with bilirubin concentration at least 3 times the serum bilirubin concentration measured at the same time on or after the 3rd postoperative day, or as the need for radiologic or surgical intervention because of biliary collections.

Secondary Outcome Measures

Name	Time	Method
Type of re-intervention	6 month	the number of intervention required for each patient totally
Postoperative bilirubin level	7 days	the rate of decreased bilirubin postoperatively
Total cost of treatment	Through study completion, average 6 month	The cost of intervention and management of postoperative complications
Visual analogue score	3 days	the severity of postoperative pain. from 0 (no pain) to 10 (maximum pain)
The number of patients need postoperative opioid	3 days	The patients need of postoperative opioid (pethidine Hcl 50 mg)
Return to normal activity	30 days	the number of days required for the patient to return to normal activity
Hospital stays	10 days	the number of days in hospital from the day of operation to the day of discharge
Drain-carried time	20 days	the number of days before drain removal

Trial Locations

Locations (1)

Mohammed Ahmed Omar; 🇪🇬 Sohag, Qena, Egypt