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Risk Factors and Outcome of Biliary Complications Following Adult Living Donor Liver Transplantation

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ClinicalTrials.gov Identifier: NCT03789383
Recruitment Status : Not yet recruiting
First Posted : December 28, 2018
Last Update Posted : January 4, 2019
Sponsor:
Information provided by (Responsible Party):
Sara Ali Hassan, Assiut University

Brief Summary:

Liver transplantation (LT) is a live-saving therapy for patients with complicated chronic liver diseases and acute liver failure .Even though many complications can occur after LT, biliary complications (BC) are both common and potentially severe .

a prospective study and retrospective part from hospital records.

Aim of the study:

  1. Detect frequency, risk factors for development of biliary complications post living donor liver transplantation, types (stricture anastomotic or not, leak, biloma, stone, cholangitis etc.…).
  2. Evaluate outcomes of different biliary complications

Condition or disease
Liver Transplant; Complications

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Other
Time Perspective: Other
Official Title: Risk Factors and Outcome of Biliary Complications Following Adult Living Donor Liver Transplantation in Al-Rajhy Liver Hospital in Upper Egypt.
Estimated Study Start Date : January 1, 2019
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : February 1, 2022

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Incidence of biliary complications [ Time Frame: 1 year after liver transplantation ]
    Biliary complications include biliary leak or stricture (anastomotic or non anastomotic), the investigator will record nature of complication , its time of presentation and number of hospital re-admissions due to biliary complications.

  2. Type of intervention done to each complication [ Time Frame: 1 year after liver transplantation ]
    Intervention is either non surgical (ERCP or PTD) or surgical revision with detailed description of each intervention and if the intervention is successful or not (biliary stricture resolved by MRCP, improvement of liver functions and symptoms)



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults more than 18 y with living donor liver transplantation in Al-Rajhy liver hospital, Assiut university, Egypt.
Criteria

Inclusion Criteria:

  • Adults more than 18 y with living donor liver transplantation in Al-Rajhy liver hospital , Assiut university,Egypt

Exclusion Criteria:

  • pediatric liver transplantation
  • cadaveric liver transplantation

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): NCT03789383


Contacts
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Contact: Sara Sedeek +201022177340 sara_ali@aun.edu.eg

Locations
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Egypt
Al-Rajhy liver hospital Not yet recruiting
Assiut, Egypt
Contact: Sara Sedeek       sara_ali@aun.edu.eg   
Principal Investigator: Madiha El-attar         
Principal Investigator: Mohamed Abd-elmalek         
Principal Investigator: Sara Sedeek         
Sponsors and Collaborators
Assiut University

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Responsible Party: Sara Ali Hassan, Clinical teaching assistant in department of Tropical Medicine and Gastroenterology, Assiut University
ClinicalTrials.gov Identifier: NCT03789383     History of Changes
Other Study ID Numbers: RFLTIUNE
First Posted: December 28, 2018    Key Record Dates
Last Update Posted: January 4, 2019
Last Verified: January 2019

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