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.
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
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
211
closure of common bile duct over T tube
Primary closure of common bile duct
Closure of common bile duct over antegrade plastic biliary stent
Mohammed Ahmed Omar
Sohag, Qena Governorate, Egypt
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.
Time frame: 3rd to 7th postoperative day
Post operative biliary stricture
The segmental shrunken of CBD diameter and proximal dilatation by MRCP.
Time frame: 6 month
Recurrent biliary stones
Common bile duct stone after 6 months of the procedure
Time frame: 6 month
Visual analogue score
the severity of postoperative pain. from 0 (no pain) to 10 (maximum pain)
Time frame: 3 days
The number of patients need postoperative opioid
The patients need of postoperative opioid (pethidine Hcl 50 mg)
Time frame: 3 days
Postoperative bilirubin level
the rate of decreased bilirubin postoperatively
Time frame: 7 days
Hospital stays
the number of days in hospital from the day of operation to the day of discharge
Time frame: 10 days
Drain-carried time
the number of days before drain removal
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Time frame: 20 days
Total cost of treatment
The cost of intervention and management of postoperative complications
Time frame: Through study completion, average 6 month
Return to normal activity
the number of days required for the patient to return to normal activity
Time frame: 30 days
Type of re-intervention
the number of intervention required for each patient totally
Time frame: 6 month