Comparative Study of Three Common Bile Duct Closure Techniques
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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: T tube drainage
closure of common bile duct over T tube
Procedure: Antegrade stenting
Closure of common bile duct over antegrade plastic biliary stent
|
| Experimental: Antegrade stenting Closure of common bile duct over antegrade biliary plastic stent |
Procedure: T tube drainage
closure of common bile duct over T tube
Procedure: Primary closure
Primary closure of common bile duct
|
Outcome Measures
Primary Outcome Measures
- 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.
- 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
Secondary Outcome Measures
- 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)
- Postoperative bilirubin level [7 days]
the rate of decreased bilirubin postoperatively
- 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
- Total cost of treatment [Through study completion, average 6 month]
The cost of intervention and management of postoperative complications
- Return to normal activity [30 days]
the number of days required for the patient to return to normal activity
- Type of re-intervention [6 month]
the number of intervention required for each patient totally
Eligibility Criteria
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,
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biliary malformation,
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distal CBD stenosis and or obstruction,
-
trans-cystic stone extraction,
-
explorations followed by choledochojejunostomy and choledochoduodenostomy.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mohammed Ahmed Omar | Sohag | Qena | Egypt | 83523 |
Sponsors and Collaborators
- South Valley University
Investigators
- Principal Investigator: Mohammed A. Omar, Ass. Prof., South Valley University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SVU 300