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

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.

Study Overview

• Status: Completed
• Conditions: Biliary Obstruction; Choledochal Cyst
• Intervention / Treatment: Procedure: Isolated Vascularized Gastric Tube (IVGT) graft

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.

• Study Type: Observational
• Enrollment (Actual): 8

Contacts and Locations

Study Locations

• South Africa
  • Kwazulu Natal
    • Pietermaritzburg, Kwazulu Natal, South Africa, 3201
      • Greys Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 8 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• biliary atresia

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bile drainage	Effectiveness of procedure to allow drainage of bile into the bowel.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications of procedure	What complications were encountered following the procedure	30 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications	What were the long term complications	1 year

Collaborators and Investigators

• Sponsor: University of KwaZulu

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2005
• Primary Completion (Actual): January 1, 2020
• Study Completion (Actual): January 1, 2020

Study Registration Dates

• First Submitted: March 19, 2020
• First Submitted That Met QC Criteria: March 23, 2020
• First Posted (Actual): March 24, 2020

Study Record Updates

• Last Update Posted (Actual): March 30, 2020
• Last Update Submitted That Met QC Criteria: March 25, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Roux-en-Y; Paediatric; Choledochal cyst; Bile drainage; Gastric conduit
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Cysts; Congenital Abnormalities; Biliary Tract Diseases; Bile Duct Diseases; Digestive System Abnormalities; Choledochal Cyst
• Other Study ID Numbers: C3619112712050

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Data will be retained by researchers and ade available on request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No