Skip to main content
OpenTrials
Completed

NCT Number: NCT04264299

Comparative Study of Three Common Bile Duct Closure Techniques

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mohammed Ahmed Omar

Sohag, Qena Governorate, 83523, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

T tube drainage

Procedure

closure of common bile duct over T tube

Primary closure

Procedure

Primary closure of common bile duct

Antegrade stenting

Procedure

Closure of common bile duct over antegrade plastic biliary stent

Primary outcomes

  1. Postoperative bile leak

    Time frame: 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.

  2. Post operative biliary stricture

    Time frame: 6 month

    The segmental shrunken of CBD diameter and proximal dilatation by MRCP.

  3. Recurrent biliary stones

    Time frame: 6 month

    Common bile duct stone after 6 months of the procedure

Secondary outcomes

  1. Visual analogue score

    Time frame: 3 days

    the severity of postoperative pain. from 0 (no pain) to 10 (maximum pain)

  2. The number of patients need postoperative opioid

    Time frame: 3 days

    The patients need of postoperative opioid (pethidine Hcl 50 mg)

  3. Postoperative bilirubin level

    Time frame: 7 days

    the rate of decreased bilirubin postoperatively

  4. Hospital stays

    Time frame: 10 days

    the number of days in hospital from the day of operation to the day of discharge

  5. Drain-carried time

    Time frame: 20 days

    the number of days before drain removal

  6. Total cost of treatment

    Time frame: Through study completion, average 6 month

    The cost of intervention and management of postoperative complications

  7. Return to normal activity

    Time frame: 30 days

    the number of days required for the patient to return to normal activity

  8. Type of re-intervention

    Time frame: 6 month

    the number of intervention required for each patient totally

Sponsors and collaborators

Lead sponsor

South Valley University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Feb 11, 2020
Registry last updated
May 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.