NCT03636321

Brief Summary

Determination of biliary complications in stented group compared to duct to duct anastomosis without stent

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2018

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

First Submitted

Initial submission to the registry

August 2, 2018

Completed
8 days until next milestone

Study Start

First participant enrolled

August 10, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 17, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2019

Completed
Last Updated

May 18, 2020

Status Verified

May 1, 2020

Enrollment Period

1.3 years

First QC Date

August 2, 2018

Last Update Submit

May 14, 2020

Conditions

Liver Transplant

Keywords

living donor liver transplantationintraductal stentbiliary complications after liver transplantation

Outcome Measures

Primary Outcomes (1)

  • biliary complications after living donor liver transplantation

    incidence of biliary complications after living donor liver transplantation

    one year

Secondary Outcomes (5)

  • biliary complications

    one year

  • biliary related mortality

    one year

  • rate of cholangitis

    3 months

  • hospital stay

    one month

  • time 2 biliary complications

    one year

Other Outcomes (1)

  • skeletonization of duct

    10 hours

Study Arms (2)

intraductal stent

EXPERIMENTAL

in this group ,patients candidate for living donor liver transplantation duct to duct biliary anastomosis with internal biliary stent

Procedure: living donor liver transplantation with internal biliary stent

stentless

ACTIVE COMPARATOR

in this group ,patients candidate for living donor liver transplantation duct to duct biliary anastomosis will done without internal biliary

Procedure: living donor liver transplantation with internal biliary stent

Interventions

living donor liver transplantation with internal biliary stentPROCEDURE

living donor liver transplantation without internal biliary stent

intraductal stentstentless

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • adult patients eligible for a liver transplantation
  • patients' written informed consent signed.

You may not qualify if:

  • biliary reconstruction requires a hepatico-jejunostomy for anatomical/biliary disease reason.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Air force spcialized hospital

Cairo, 11865, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

August 2, 2018

First Posted

August 17, 2018

Study Start

August 10, 2018

Primary Completion

November 10, 2019

Study Completion

November 10, 2019

Last Updated

May 18, 2020

Record last verified: 2020-05

Locations

EG(1)