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Completed

NCT Number: NCT04319302

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.

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Key information

Conditions

Biliary Obstruction Bile Duct Diseases Biliary Tract Diseases Choledochal Cyst Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cysts Digestive System Abnormalities Digestive System Diseases Neoplasms

Age range

Up to 12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Greys Hospital

Pietermaritzburg, KwaZulu-Natal, 3201, South Africa

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • biliary atresia

Treatment and study plan

Isolated Vascularized Gastric Tube (IVGT) graft

Procedure

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.

Primary outcomes

  1. Bile drainage

    Time frame: 30 days

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

Secondary outcomes

  1. Complications of procedure

    Time frame: 30 days

    What complications were encountered following the procedure

Other outcomes

  1. Complications

    Time frame: 1 year

    What were the long term complications

Sponsors and collaborators

Lead sponsor

University of KwaZulu

Other

Registry information

Important dates

Study start
2005
Primary completion
2020
Study completion
2020
First posted
Mar 24, 2020
Registry last updated
Mar 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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