Peri Kasai Portoenterostomy Anchoring of the Jejunal Loop

NCT ID: NCT04961034

Last Updated: 2022-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2023-12-20

Brief Summary

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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

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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.

Conditions

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Biliary Atresia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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classic KPE

the classic management of biliary atresia as described

Group Type OTHER

kasai portoenterostomy

Intervention Type PROCEDURE

surgical creation of stoma between porta hepatis and jejunal loop

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

Group Type OTHER

kasai portoenterostomy

Intervention Type PROCEDURE

surgical creation of stoma between porta hepatis and jejunal loop

Interventions

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kasai portoenterostomy

surgical creation of stoma between porta hepatis and jejunal loop

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* infants older than 60 days
Minimum Eligible Age

4 Weeks

Maximum Eligible Age

8 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Mohammad Gharieb Mohammad Khirallah

Associate professor of pediatric surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tanta University

Tanta, Gharbia Governorate, Egypt

Site Status COMPLETED

Tantra Universiy

Tanta, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mohammad Khirallah

Role: CONTACT

+201003546853

Facility Contacts

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Mohammad Khirallah

Role: primary

+201003546853

Other Identifiers

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33943/7/20

Identifier Type: -

Identifier Source: org_study_id

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