Peri Kasai Portoenterostomy Anchoring of the Jejunal Loop

April 26, 2022 updated by: Mohammad Gharieb Mohammad Khirallah, Tanta University
the study of the effect o the hanging of the jejunal loop to the peri KPE Glisson capsule on the rate of bile drainage and requirement of liver transplantation

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

To evaluate the effect of anchoring jejunal loop to Glisson capsule of liver after completion of modified Kasai portoenterostomy (KPE) on the frequency of attacks of cholangitis and the overall incidence of native liver survival.

Methods: Retrospective study included 29 infants diagnosed as biliary atresia (BA). They were subjected to modified KPE. Two subgroups were present. Group A included 16 infants and had KPE. Group B included 13 infants and had the assumed modification. Wider dissection of fibrous portal plate was considered in both groups. After completion of KPE, the jejunal loop anchored to Glisson capsule of liver at porta hepatis in group B.

Study Type

Interventional

Enrollment (Anticipated)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Gharbeya
      • Tanta, Gharbeya, Egypt, 31111
        • Completed
        • Tanta University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 weeks to 1 month (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • infants with biliary atresia diagnosed and treated before 60th day of age

Exclusion Criteria:

  • infants older than 60 days

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SEQUENTIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: classic KPE
the classic management of biliary atresia as described
Procedure: kasai portoenterostomy
surgical creation of stoma between porta hepatis and jejunal loop
OTHER: modified KPE
we added 2 sutures posterior, one on each side and two anterior. this will hang the jejunal loop to promote tension free anastomosis
Procedure: kasai portoenterostomy
surgical creation of stoma between porta hepatis and jejunal loop

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the total number of cholangitis
Time Frame: two years
the total attacks of chollangitis
two years
number of native liver survivors
Time Frame: two years
the decrease of the need of liver transplantation in children with biliary atresia
two years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
early improvement of liver functions
Time Frame: 6 months
normalization of liver function
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2015

Primary Completion (ACTUAL)

June 1, 2021

Study Completion (ANTICIPATED)

December 20, 2023

Study Registration Dates

First Submitted

July 9, 2021

First Submitted That Met QC Criteria

July 9, 2021

First Posted (ACTUAL)

July 14, 2021

Study Record Updates

Last Update Posted (ACTUAL)

April 27, 2022

Last Update Submitted That Met QC Criteria

April 26, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 33943/7/20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

publication as article

IPD Sharing Time Frame

6 months

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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