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Trial record 17 of 883 for:    Liver Transplant

Stented Biliary Anastomosis in Living Donor Liver Transplantation

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ClinicalTrials.gov Identifier: NCT03636321
Recruitment Status : Not yet recruiting
First Posted : August 17, 2018
Last Update Posted : August 17, 2018
Sponsor:
Information provided by (Responsible Party):
Alaa Mstafa Hassan Sewefy, Minia University

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

Condition or disease Intervention/treatment Phase
Liver Transplant Procedure: living donor liver transplantation with intraductal stent Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Randomized Controlled Clinical Trial Of Stented Versus Stentless Biliary Anastomosis In Living Donor Liver Transplantation
Estimated Study Start Date : August 10, 2018
Estimated Primary Completion Date : November 10, 2019
Estimated Study Completion Date : November 10, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: intraductal stent
in this group ,patients candidate for living donor liver transplantation duct to duct biliary anastomosis will done on intraductal custom made stent
Procedure: living donor liver transplantation with intraductal stent
living donor liver transplantation with intraductal stent

Active Comparator: stentless
in this group ,patients candidate for living donor liver transplantation duct to duct biliary anastomosis will done without stent
Procedure: living donor liver transplantation with intraductal stent
living donor liver transplantation with intraductal stent




Primary Outcome Measures :
  1. biliary complications after living donor liver transplantation [ Time Frame: one year ]
    incidence of biliary complications after living donor liver transplantation


Secondary Outcome Measures :
  1. intraoperative bleeding [ Time Frame: 10 hours ]
    intraoperative bleeding

  2. operative time [ Time Frame: 10 hours ]
    time of operation from skin to skin

  3. operative related mortality [ Time Frame: one month ]
    mortality


Other Outcome Measures:
  1. thrombosis of the artery [ Time Frame: 10 hours ]
    intraoperative thrombosis of the hepatic artery

  2. skeletonization of duct [ Time Frame: 10 hours ]
    skeletonization of duct



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03636321


Contacts
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Contact: Amr A Abdelaal, MD 01223108501 ext 002 aaabdelaal@yahoo.com
Contact: Mina M Hendi, MS 01009873949 ext 002 dr.minahendy@yahoo.com

Locations
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Egypt
Minia university hospital Not yet recruiting
Minia, Egypt, 61511
Contact: Mina M Hendi, MS    01009873949 ext 002    dr.minahendy@yahoo.com   
Contact: Abubakr M Mohie Eldien, MD    01066338823 ext 002    abubakr.mohie@yahoo.com   
Sponsors and Collaborators
Alaa Mstafa Hassan Sewefy

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Responsible Party: Alaa Mstafa Hassan Sewefy, professor, Minia University
ClinicalTrials.gov Identifier: NCT03636321     History of Changes
Other Study ID Numbers: AS.fac.med.55
First Posted: August 17, 2018    Key Record Dates
Last Update Posted: August 17, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Alaa Mstafa Hassan Sewefy, Minia University:
living donor liver transplantation
intraductal stent
biliary complications after liver transplantation

Additional relevant MeSH terms:
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Liver Extracts
Hematinics