NCT04319302

Brief Summary

This was a retrospective case series experience of paediatric patients who had an Isolated vascularized gastric tube biliary enteric drainage procedure for biliary obstruction over the past five years. We reviewed our experience and outcomes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
15 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 24, 2020

Completed
Last Updated

March 30, 2020

Status Verified

March 1, 2020

Enrollment Period

15 years

First QC Date

March 19, 2020

Last Update Submit

March 25, 2020

Conditions

Keywords

Choledochal cystPaediatricRoux-en-YBile drainageGastric conduit

Outcome Measures

Primary Outcomes (1)

  • Bile drainage

    Effectiveness of procedure to allow drainage of bile into the bowel.

    30 days

Secondary Outcomes (1)

  • Complications of procedure

    30 days

Other Outcomes (1)

  • Complications

    1 year

Study Arms (1)

Paediatric biliary obstruction

This was a retrospective review of all paediatric patients who had undergone an IVGT graft procedure for biliary tract anatomical obstruction in the past five years. We looked at the indications for surgery, the demographic profile of the patients, outcomes following surgery and outlined the surgical technique used.

Procedure: Isolated Vascularized Gastric Tube (IVGT) graft

Interventions

A conduit was created by tubularising a vascularized segment of the greater curve of the antrum of the stomach and this was used between the remaining common hepatic duct and the duodenum.

Paediatric biliary obstruction

Eligibility Criteria

AgeUp to 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

This was a retrospective review of all paediatric patients at Greys Hospital who had undergone an IVGT graft procedure for biliary tract anatomical obstruction in the past five years

You may qualify if:

  • All patients from birth to 12 years with biliary tract obstruction requiring surgery.

You may not qualify if:

  • biliary atresia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Greys Hospital

Pietermaritzburg, KwaZulu-Natal, 3201, South Africa

Location

MeSH Terms

Conditions

Choledochal Cyst

Interventions

Transplantation

Condition Hierarchy (Ancestors)

CystsNeoplasmsBile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesDigestive System AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Paediatric Surgery, Greys Hospital

Study Record Dates

First Submitted

March 19, 2020

First Posted

March 24, 2020

Study Start

January 1, 2005

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

March 30, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Data will be retained by researchers and ade available on request.

Locations