Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04319302
Other study ID # C3619112712050
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT03118973 - Evaluation of Efficacy and Safety of Goff Transpancreatic Septotomy vs. Double Wire Technique for Achieving Biliary Access in Technically Challenging ERCPs N/A
Recruiting NCT05429203 - Comparison of Duodenoscope With Single-use Distal Cover and the Conventional Reusable Duodenoscope N/A
Completed NCT03002051 - EUS-guided Transenteric Drainage With a Novel Lumen-apposing Metal Stent N/A
Terminated NCT00990366 - Treatment of Biliary Obstruction Using Biliary Stent With or Without Antireflux Valve N/A
Recruiting NCT04929821 - UNITY-B A Prospective, Multicentric, Single-arm Study to Evaluate the Safety and Efficacy of the UNITY-B Biodegradable Balloon-Expandable Biliary Stent System in Subjects With Biliary Strictures N/A
Completed NCT03074201 - Prospective Evaluation of the Ability of Spyglass Cholangioscopy to Facilitate Radiation Free ERCP N/A
Recruiting NCT01522573 - T-EUS for Gastrointestinal Disorders: A Multicenter Registry N/A
Recruiting NCT01524146 - Photodynamic Therapy (PDT) Cholangiocarcinoma Registry N/A
Completed NCT04595058 - LAMS Choledochoduodenostomies: With or Without Coaxial Plastic Stent N/A
Completed NCT03962478 - Combined Stent Insertion and HIFU Ablation for Pancreatic Carcinoma With Biliary Obstruction N/A
Completed NCT02460432 - Comparison of Drug Eluting Stent and Covered Metal Stent in Malignant Biliary Obstruction (MIRA III) N/A
Active, not recruiting NCT03997994 - DIGEST I Drug Coated Balloon for Biliary Stricture N/A
Completed NCT03870386 - EUS Biliary Drainage vs. ERCP N/A
Not yet recruiting NCT06287112 - Prevention of Acute Cholecystitis With ETGBD N/A
Completed NCT03925766 - Laparoscopy-Assisted Transgastric ERCP
Recruiting NCT00731419 - Randomised Trial Comparing Metal and Plastic Biliary Stents Stents for Palliating Malignant Jaundice Phase 4
Not yet recruiting NCT05432661 - clınıcal Effects of High-flow Nasal Oxygen Use ın gerıatrıc patıents
Recruiting NCT06047990 - Endobiliary Percutaneous Cryobiopsy in Malignant Biliary Obstruction N/A
Recruiting NCT04857424 - Quality of Life Assessment Between Internal Endoscopic Versus Percutaneous Drainage in Biliary Obstruction
Not yet recruiting NCT04431427 - Partially Covered Metal Stents Efficacy in Biliary Drainage of Malignant Extra-hepatic Biliary Obstruction N/A