NCT04108780

Brief Summary

the aim is to assess the benefits and harms of T-tube drainage versus primary closure without biliary stent after exploration common bile duct stones

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2019

Typical duration for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

September 25, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

September 25, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 30, 2019

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2022

Completed
Last Updated

September 30, 2019

Status Verified

September 1, 2019

Enrollment Period

2.5 years

First QC Date

September 25, 2019

Last Update Submit

September 26, 2019

Conditions

CBD Exploration

Outcome Measures

Primary Outcomes (1)

  • bile leak from common bile duct

    Assessment which type of repair (with T-tube or primary repair) bile leak will occurs more

    baseline

Secondary Outcomes (1)

  • hospital stay length

    base line

Study Arms (2)

CBD exploration with T-tube

repair of CBD after CBD exploration over T-tube

Device: T-tube

CBD exploration with primary repair

primary repair of CBD after CBD exploration

Device: T-tube

Interventions

T-tubeDEVICE

T shaped tube used as stent after CBD exploration

CBD exploration with T-tubeCBD exploration with primary repair

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patient who will undergo CBD exploration for management of CBD stone

You may qualify if:

  • Patients who will undergo common bile duct exploration

You may not qualify if:

  • patients who has failed ERCP for management of common bile duct exploration
  • CBD diameter 2 cm or more

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Wu X, Huang ZJ, Zhong JY, Ran YH, Ma ML, Zhang HW. Laparoscopic common bile duct exploration with primary closure is safe for management of choledocholithiasis in elderly patients. Hepatobiliary Pancreat Dis Int. 2019 Dec;18(6):557-561. doi: 10.1016/j.hbpd.2019.07.005. Epub 2019 Jul 25.

    PMID: 31474445BACKGROUND

  • Guan H, Jiang G, Mao X. Primary duct closure combined with transcystic drainage versus T-tube drainage after laparoscopic choledochotomy. ANZ J Surg. 2019 Jul;89(7-8):885-888. doi: 10.1111/ans.15163. Epub 2019 May 8.

    PMID: 31067598BACKGROUND

  • Jiang C, Zhao X, Cheng S. T-Tube Use After Laparoscopic Common Bile Duct Exploration. JSLS. 2019 Jan-Mar;23(1):e2018.00077. doi: 10.4293/JSLS.2018.00077.

    PMID: 30675097BACKGROUND

Central Study Contacts

Mhamed Abo Elhassan, Master

CONTACT

+201001311044doctor_200799@yahoo.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

September 25, 2019

First Posted

September 30, 2019

Study Start

September 25, 2019

Primary Completion

March 30, 2022

Study Completion

July 30, 2022

Last Updated

September 30, 2019

Record last verified: 2019-09