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CompletedNCT03636321Updated May 18, 2020

Stented Biliary Anastomosis in Living Donor Liver Transplantation

An interventional study of living donor liver transplantation with internal biliary stent in Liver Transplant, sponsored by Alaa Mstafa Hassan Sewefy. Completed at 1 site in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2020-05-18.

Sponsored by Alaa Mstafa Hassan Sewefy · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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

Read the detailed description

30 patients included in the study. patients will be randomly allocated in two equal groups. In group A anastomosis will be done on intraductal stent and in group B anastomosis done without stent .the patients will be followed for one year to compare the result of two groups as regard biliary complications.

02

Conditions studied

  • Liver Transplant

Keywords

  • living donor liver transplantation
  • intraductal stent
  • biliary complications after liver transplantation
03

In context

Lead sponsor

This is the only study on the registry with Alaa Mstafa Hassan Sewefy as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • biliary reconstruction requires a hepatico-jejunostomy for anatomical/biliary disease reason.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    intraductal stent

    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

  • Active comparator
    stentless

    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

  • Procedureliving donor liver transplantation with internal biliary stent

    living donor liver transplantation without internal biliary stent

06

What researchers measure

Primary outcomes

  1. biliary complications after living donor liver transplantation

    incidence of biliary complications after living donor liver transplantation

    Time frame: one year

Secondary outcomes

  1. biliary complications

    types of biliary complications

    Time frame: one year

  2. biliary related mortality

    mortality

    Time frame: one year

  3. rate of cholangitis

    rate of cholangitis

    Time frame: 3 months

  4. hospital stay

    hospital stay

    Time frame: one month

  5. time 2 biliary complications

    time 2 biliary complications

    Time frame: one year

Other outcomes

  1. skeletonization of duct

    skeletonization of duct

    Time frame: 10 hours

07

Study locations

1 site
  • Air force spcialized hospital
    Cairo, 11865, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 18, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03636321
Lead sponsor
Alaa Mstafa Hassan Sewefy
Collaborators
Ain Shams University
Responsible party
Alaa Mstafa Hassan Sewefy (professor, Minia University) — Sponsor-investigator
First posted
Aug 17, 2018
Start date
Aug 10, 2018
Primary completion
Nov 10, 2019
Completion
Nov 10, 2019
Last update
May 18, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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