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

Biliary Obstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04319302
• Other study ID #: C3619112712050
• Status: Completed
• Start date: January 2005
• Est. completion date: January 2020

Study information

• Verified date: March 2020
• Source: University of KwaZulu
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: January 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 12 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• biliary atresia

Related Conditions & MeSH terms

• Biliary Obstruction
• Choledochal Cyst

Intervention

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.

Locations

Country	Name	City	State
South Africa	Greys Hospital	Pietermaritzburg	Kwazulu Natal

Sponsors (1)

Lead Sponsor	Collaborator
University of KwaZulu

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Complications	What were the long term complications	1 year
Primary	Bile drainage	Effectiveness of procedure to allow drainage of bile into the bowel.	30 days
Secondary	Complications of procedure	What complications were encountered following the procedure	30 days