Clinical trial NCT04264299: Comparative Study of Three Common Bile Duct Closure Techniques
Official title: Comparative Study of Three Common Bile Duct Closure Techniques After Choledocholithotomy: Safety and Efficacy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Common Bile Duct Closure
Keywords: choledocholithiasis
T-tube
primary repair
biliary stenting
Lead sponsor: South Valley University
Sponsor class: OTHER
First posted: 2020-02-11
Enrollment: 211
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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,
* biliary malformation,
* distal CBD stenosis and or obstruction,
* trans-cystic stone extraction,
* explorations followed by choledochojejunostomy and choledochoduodenostomy.

Primary outcomes:
measure: Postoperative bile leak
timeFrame: 3rd to 7th postoperative day
measure: Post operative biliary stricture
timeFrame: 6 month
measure: Recurrent biliary stones
timeFrame: 6 month
Secondary outcomes:
measure: Visual analogue score
timeFrame: 3 days
measure: The number of patients need postoperative opioid
timeFrame: 3 days
measure: Postoperative bilirubin level
timeFrame: 7 days
measure: Hospital stays
timeFrame: 10 days
measure: Drain-carried time
timeFrame: 20 days
measure: Total cost of treatment
timeFrame: Through study completion, average 6 month
measure: Return to normal activity
timeFrame: 30 days
measure: Type of re-intervention
timeFrame: 6 month
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Mohammed Ahmed Omar
state: Qena
Study officials:
affiliation: South Valley University
name: Mohammed A. Omar, Ass. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.