Comparative Study of Three Common Bile Duct Closure Techniques

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Common Bile Duct Closure

Intervention / Treatment
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* Procedure: T tube drainage
* Procedure: Primary closure
* Procedure: Antegrade stenting


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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choledocholithiasis, T-tube, primary repair, biliary stenting