Stented Biliary Anastomosis in Living Donor Liver Transplantation

Liver Transplant Clinical Trial

Official title:

Randomized Controlled Clinical Trial Of Stented Versus Stentless Biliary Anastomosis In Living Donor Liver Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03636321
• Other study ID #: AS.fac.med.55
• Status: Completed
• Phase: N/A
• Start date: August 10, 2018
• Est. completion date: November 10, 2019

Study information

• Verified date: May 2020
• Source: Minia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 10, 2019
• Est. primary completion date: November 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• adult patients eligible for a liver transplantation

• patients' written informed consent signed.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Liver Transplant

Intervention

Procedure:
• living donor liver transplantation with internal biliary stent
living donor liver transplantation without internal biliary stent

Locations

Country	Name	City	State
Egypt	Air force spcialized hospital	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Alaa Mstafa Hassan Sewefy	Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	skeletonization of duct	skeletonization of duct	10 hours
Primary	biliary complications after living donor liver transplantation	incidence of biliary complications after living donor liver transplantation	one year
Secondary	biliary complications	types of biliary complications	one year
Secondary	biliary related mortality	mortality	one year
Secondary	rate of cholangitis	rate of cholangitis	3 months
Secondary	hospital stay	hospital stay	one month
Secondary	time 2 biliary complications	time 2 biliary complications	one year