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Comparative Study of Three Common Bile Duct Closure Techniques

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04264299
Enrollment
211
Registered
2020-02-11
Start date
2017-01-01
Completion date
2021-04-30
Last updated
2021-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Common Bile Duct Closure

Keywords

choledocholithiasis, T-tube, primary repair, biliary stenting

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.

Interventions

PROCEDURET tube drainage

closure of common bile duct over T tube

Primary closure of common bile duct

PROCEDUREAntegrade stenting

Closure of common bile duct over antegrade plastic biliary stent

Sponsors

South Valley University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Postoperative bile leak3rd to 7th postoperative dayThe 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 stricture6 monthThe segmental shrunken of CBD diameter and proximal dilatation by MRCP.
Recurrent biliary stones6 monthCommon bile duct stone after 6 months of the procedure

Secondary

MeasureTime frameDescription
Hospital stays10 daysthe number of days in hospital from the day of operation to the day of discharge
Drain-carried time20 daysthe number of days before drain removal
Visual analogue score3 daysthe severity of postoperative pain. from 0 (no pain) to 10 (maximum pain)
Return to normal activity30 daysthe number of days required for the patient to return to normal activity
Type of re-intervention6 monththe number of intervention required for each patient totally
Total cost of treatmentThrough study completion, average 6 monthThe cost of intervention and management of postoperative complications
The number of patients need postoperative opioid3 daysThe patients need of postoperative opioid (pethidine Hcl 50 mg)
Postoperative bilirubin level7 daysthe rate of decreased bilirubin postoperatively

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026