Back to resultsPeri Kasai Portoenterostomy Anchoring of the Jejunal Loop
Primary Purpose
Biliary Atresia
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
kasai portoenterostomy
Sponsored by
About this trial
This is an interventional treatment trial for Biliary Atresia focused on measuring biliary atresia, kasai portoenterostomy, modified, cholangitis
Eligibility Criteria
Inclusion Criteria:
- infants with biliary atresia diagnosed and treated before 60th day of age
Exclusion Criteria:
- infants older than 60 days
Sites / Locations
- Tanta University
- Tantra UniversiyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
classic KPE
modified KPE
Arm Description
the classic management of biliary atresia as described
we added 2 sutures posterior, one on each side and two anterior. this will hang the jejunal loop to promote tension free anastomosis
Outcomes
Primary Outcome Measures
the total number of cholangitis
the total attacks of chollangitis
number of native liver survivors
the decrease of the need of liver transplantation in children with biliary atresia
Secondary Outcome Measures
early improvement of liver functions
normalization of liver function
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04961034
Brief Title
Peri Kasai Portoenterostomy Anchoring of the Jejunal Loop
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 2015 (Actual)
Primary Completion Date
June 2021 (Actual)
Study Completion Date
December 20, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biliary Atresia
Keywords
biliary atresia, kasai portoenterostomy, modified, cholangitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
26 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
classic KPE
Arm Type
Other
Arm Description
the classic management of biliary atresia as described
Arm Title
modified KPE
Arm Type
Other
Arm Description
we added 2 sutures posterior, one on each side and two anterior. this will hang the jejunal loop to promote tension free anastomosis
Intervention Type
Procedure
Intervention Name(s)
kasai portoenterostomy
Intervention Description
surgical creation of stoma between porta hepatis and jejunal loop
Primary Outcome Measure Information:
Title
the total number of cholangitis
Description
the total attacks of chollangitis
Time Frame
two years
Title
number of native liver survivors
Description
the decrease of the need of liver transplantation in children with biliary atresia
Time Frame
two years
Secondary Outcome Measure Information:
Title
early improvement of liver functions
Description
normalization of liver function
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Weeks
Maximum Age & Unit of Time
8 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
infants with biliary atresia diagnosed and treated before 60th day of age
Exclusion Criteria:
infants older than 60 days
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohammad Khirallah
Phone
+201003546853
Email
mohamed.khirallah@med.tanta.edu.eg
Facility Information:
Facility Name
Tanta University
City
Tanta
State/Province
Gharbeya
ZIP/Postal Code
31111
Country
Egypt
Individual Site Status
Completed
Facility Name
Tantra Universiy
City
Tanta
ZIP/Postal Code
31512
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammad Khirallah
Phone
+201003546853
Email
mohamed.khirallah@med.tanta.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
publication as article
IPD Sharing Time Frame
6 months
Learn more about this trial
Peri Kasai Portoenterostomy Anchoring of the Jejunal Loop
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