NCT04264299

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
211

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 7, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 11, 2020

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

May 11, 2021

Status Verified

May 1, 2021

Enrollment Period

3 years

First QC Date

February 7, 2020

Last Update Submit

May 7, 2021

Conditions

Common Bile Duct Closure

Keywords

choledocholithiasisT-tubeprimary repairbiliary stenting

Outcome Measures

Primary Outcomes (3)

  • 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.

    3rd to 7th postoperative day

  • Post operative biliary stricture

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

    6 month

  • Recurrent biliary stones

    Common bile duct stone after 6 months of the procedure

    6 month

Secondary Outcomes (8)

  • Visual analogue score

    3 days

  • The number of patients need postoperative opioid

    3 days

  • Postoperative bilirubin level

    7 days

  • Hospital stays

    10 days

  • Drain-carried time

    20 days

  • +3 more secondary outcomes

Study Arms (3)

T tube drainage

ACTIVE COMPARATOR

Closure of common bile duct after choledocholithotomy over T tube

Procedure: Primary closureProcedure: Antegrade stenting

Primary closure

EXPERIMENTAL

Primary closure of the common bile duct after choledocholithotomy

Procedure: T tube drainageProcedure: Antegrade stenting

Antegrade stenting

EXPERIMENTAL

Closure of common bile duct over antegrade biliary plastic stent

Procedure: T tube drainageProcedure: Primary closure

Interventions

T tube drainagePROCEDURE

closure of common bile duct over T tube

Antegrade stentingPrimary closure
Primary closurePROCEDURE

Primary closure of common bile duct

Antegrade stentingT tube drainage
Antegrade stentingPROCEDURE

Closure of common bile duct over antegrade plastic biliary stent

Primary closureT tube drainage

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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,

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mohammed Ahmed Omar

Sohag, Qena Governorate, 83523, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 35786738DERIVED

MeSH Terms

Conditions

Choledocholithiasis

Condition Hierarchy (Ancestors)

Common Bile Duct DiseasesBile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesCholelithiasis

Study Officials

  • Mohammed A. Omar, Ass. Prof.

    South Valley University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor of HPB surgery

Study Record Dates

First Submitted

February 7, 2020

First Posted

February 11, 2020

Study Start

January 1, 2017

Primary Completion

January 1, 2020

Study Completion

April 30, 2021

Last Updated

May 11, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)