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CompletedNCT04319302Updated Mar 30, 2020

Isolated Vascularized Gastric Tube Biliary Enteric Drainage: A Paediatric Case Series Experience.

An observational study in Biliary Obstruction and Choledochal Cyst, sponsored by University of KwaZulu. Completed at 1 site in South Africa. Open to participants aged Up to 12 Years. Per ClinicalTrials.gov, last updated 2020-03-30.

Sponsored by University of KwaZulu · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
8
Ages
Up to 12 Years
Sex
All
01

Study 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.

Read the detailed description

Background

Despite the enormous surgical advancements in the last century, access to the biliary system is lost when a Roux-en-Y (RY) biliary drainage procedure is performed. Attempts have been made to overcome this inconvenient sequel of RY biliary drainage by the use of variations in the RY anastomosis, small bowel grafts and vascular grafts. These have been predominantly unsuccessful. The use of an Isolated Vascularized Gastric Tube (IVGT) graft has been reported in the literature, and this was successfully used for adult patients with common bile duct injuries. The investigators have adopted the technique of using an IVGT graft for bile duct reconstruction in the paediatric patients at their institution.

Method

The investigators reviewed theirr experience at Greys Hospital, Pietermaritzburg. 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. The investgators looked at the indications for surgery, the demographic profile of the patients, outcomes following surgery and outlined the surgical technique used.

02

Conditions studied

  • Biliary Obstruction
  • Choledochal Cyst

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Keywords

  • Choledochal cyst
  • Paediatric
  • Roux-en-Y
  • Bile drainage
  • Gastric conduit
03

In context

Choledochal Cyst

22 studies on the registry are indexed under Choledochal Cyst; 10 are open to participants now.

This study's enrollment of 8 is below the median of 400 across 14 observational studies indexed under Choledochal Cyst.

Browse Choledochal Cyst studies →

Lead sponsor

University of KwaZulu is the lead sponsor of 34 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • biliary atresia
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
8 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • ProcedureIsolated Vascularized Gastric Tube (IVGT) graft

    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.

06

What researchers measure

Primary outcomes

  1. Bile drainage

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

    Time frame: 30 days

Secondary outcomes

  1. Complications of procedure

    What complications were encountered following the procedure

    Time frame: 30 days

Other outcomes

  1. Complications

    What were the long term complications

    Time frame: 1 year

07

Study locations

1 site
  • Greys Hospital
    Pietermaritzburg, Kwazulu Natal 3201, South Africa
08

References and documents

Individual participant data

Plan to share: No — Data will be retained by researchers and ade available on request.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2005 to primary completion in Jan 2020, 180 months.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 19, 2020
First posted
Mar 24, 2020
StartActual
Jan 2005
Primary completionActual
Jan 2020
CompletionActual
Jan 2020
Last update
Mar 30, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 30, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04319302
Lead sponsor
University of KwaZulu
Responsible party
Hansraj Mangray (Head of Paediatric Surgery, Greys Hospital, University of KwaZulu) — Principal investigator
First posted
Mar 24, 2020
Start date
Jan 2005
Primary completion
Jan 2020
Completion
Jan 2020
Last update
Mar 30, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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