Trail to Investigate the Effectiveness of CoSeal in Reducing Adhesions Following the Kasai Hepatoportoenterostomy for Biliary Atresia

• Conditions: Biliary Atresia
• Interventions: Device: CoSeal spray

• Registration Number: NCT01745991
• Lead Sponsor: Naved Alizai

Brief Summary

The investigators plan to invite all children in the UK with biliary atresia, treated at the three national centres (Birmingham, Kings College and Leeds), over a three year period to take part in a randomised control study. The investigators aim to determine the effectiveness of CoSeal® Surgical Sealant (an anti-adhesive agent) in reducing intra-abdominal adhesions (scar tissue) and the morbidity caused by these adhesions in children treated with a Kasai hepatoportoenterostomy. Adhesions are common, if not invariable, after any abdominal surgery. They cause intra-abdominal organs to become stuck to each other and the abdominal wall. This means they are no longer completely free to slide over each other. In particular patients have a lifetime risk that the bowel can become kinked or twisted leading to complications such as bowel obstruction. Adhesions also make repeat abdominal operations more difficult. The adhesions have to be divided in order to separate the organs from each other and the abdominal wall. This can lead to blood loss and increases the risk of damage to these organs. Anti-adhesive agents have been created to reduce the severity of these adhesions, but there is little in the medical literature to evaluate their effectiveness, particularly in children. Biliary atresia is an obliterative obstruction of the bile ducts that occurs in infants. Initially they are treated by an abdominal operation called a Kasai portoenterostomy to restore bile flow from the liver to the intestines. However approximately 40% of these children will go on to require a liver transplant operation in the first two years of life. If CoSeal® Surgical Sealant is effective this could reduce the patients lifetime risk of complications from abdominal adhesions and also facilitate repeat abdominal operations for these children, in particular for those who go on to require a liver transplant.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2012-12-06
• Study First Submitted QC: 2012-12-07
• Study First Posted: 2012-12-10
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-13
• Last Update Posted: 2014-09-16
• Primary Completion: 2015-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 126

Inclusion Criteria

• All patients with Biliary Atresia undergoing Kasai Hepatoportoenterostomy.

Exclusion Criteria

• Patients with BA and malrotation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Biliary Atresia undergoing Kasai op	CoSeal spray	Randomisation for the use of CoSeal at the time of Kasai and assessment at the time of Transplantation.

Primary Outcome Measures

Name	Time	Method
Severity of Intra-abdominal adhesions	5 years	Adhesions assessed at the time of Liver transplantation

Secondary Outcome Measures

Name	Time	Method
Liver transplantation- blood loss	5 years
Liver Transplantation- Time taken	5 years

Trial Locations

Locations (3)

Khalid Sharif; 🇬🇧 Birmingham Children's Hospital, United Kingdom

Mark Davenport; 🇬🇧 Kings College Hospital, London, United Kingdom

Leeds General Infirmary; 🇬🇧 Leeds, West Yorkshire, United Kingdom