Comparative Study of Three Common Bile Duct Closure Techniques

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

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.

Study Overview

• Status: Completed
• Conditions: Common Bile Duct Closure
• Intervention / Treatment: Procedure: Primary closure; Procedure: Antegrade stenting; Procedure: T tube drainage

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 Type: Interventional
• Enrollment (Actual): 211
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Qena
    • Sohag, Qena, Egypt, 83523
      • Mohammed Ahmed Omar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: T tube drainage; Closure of common bile duct after choledocholithotomy 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
Experimental: Primary closure; Primary closure of the common bile duct after choledocholithotomy	Procedure: Antegrade stenting; Closure of common bile duct over antegrade plastic biliary stent; Procedure: T tube drainage; closure of common bile duct over T tube
Experimental: Antegrade stenting; Closure of common bile duct over antegrade biliary plastic stent	Procedure: Primary closure; Primary closure of common bile duct; Procedure: T tube drainage; closure of common bile duct over T tube

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative bile leak	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.	3rd to 7th postoperative day
Post operative biliary stricture	The segmental shrunken of CBD diameter and proximal dilatation by MRCP.	6 month
Recurrent biliary stones	Common bile duct stone after 6 months of the procedure	6 month

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: South Valley University
• Investigators: Principal Investigator: Mohammed A. Omar, Ass. Prof., South Valley University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): January 1, 2020
• Study Completion (Actual): April 30, 2021

Study Registration Dates

• First Submitted: February 7, 2020
• First Submitted That Met QC Criteria: February 7, 2020
• First Posted (Actual): February 11, 2020

Study Record Updates

• Last Update Posted (Actual): May 11, 2021
• Last Update Submitted That Met QC Criteria: May 7, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: choledocholithiasis; T-tube; primary repair; biliary stenting
• Other Study ID Numbers: SVU 300

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No