Peri Kasai Portoenterostomy Anchoring of the Jejunal Loop | NCT04961034

Studies
Peri Kasai Portoenterostomy Anchoring of the Jejunal Loop

NCT04961034

Sponsor

Tanta University

Status

Unknown status

Last Update Posted

Apr 27, 2022Actual

Enrollment

26Estimated

Phase

Not Applicable

Conditions

Biliary Atresia

Interventions

kasai portoenterostomy

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2015Actual

Primary Completion Date

Jun 2021Actual

Completion Date

Dec 20, 2023Estimated

First Submitted Date

Jul 9, 2021

First Submission Date that Met QC Criteria

Jul 9, 2021

First Posted Date

Jul 14, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 26, 2022

Last Update Posted Date

Apr 27, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mohammad Gharieb Mohammad Khirallah, Associate professor of pediatric surgery, Tanta UniversityPrincipal Investigator

Lead Sponsor

Tanta UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

26Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
classic KPE	Other	the classic management of biliary atresia as described	Procedure: kasai portoenterostomy
modified KPE	Other	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
kasai portoenterostomy	Procedure	surgical creation of stoma between porta hepatis and jejunal loop	classic KPE modified KPE

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

infants older than 60 days

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Weeks

Maximum Age

8 Weeks

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mohammad Khirallah	Contact	+201003546853		mohamed.khirallah@med.tanta.edu.eg

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tanta University	Completed	Tanta	Gharbia Governorate	31111	Egypt
Tantra Universiy

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

publication as article

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code

Time Frame

6 months

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001656	Biliary Atresia
D002761	Cholangitis

Ancestor Terms

ID	Term
D001649	Bile Duct Diseases
D001660	Biliary Tract Diseases
D004066	Digestive System Diseases
D004065	Digestive System Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011171	Portoenterostomy, Hepatic

Ancestor Terms

ID	Term
D000714	Anastomosis, Surgical
D013514	Surgical Procedures, Operative
D001662	Biliary Tract Surgical Procedures
D013505	Digestive System Surgical Procedures

Browse Leaves

Not provided

Browse Branches

Not provided