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

Biliary Atresia Clinical Trial

— CoSRCT  

Official title:

Randomised Control Trial to Investigate the Effectiveness of CoSeal® Surgical Sealant in Reducing Intra-abdominal Adhesions Following the Kasai Hepatoportoenterostomy for Biliary Atresia.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01745991
• Other study ID #: NKA/LTHT/UK/CoSealRCT
• Status: Recruiting
• Phase: N/A
• First received: December 6, 2012
• Last updated: September 13, 2014
• Start date: December 2012
• Est. completion date: December 2017

Study information

• Verified date: September 2014
• Source: The Leeds Teaching Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 126
• Est. completion date: December 2017
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 6 Months

Eligibility

Inclusion Criteria:

• All patients with Biliary Atresia undergoing Kasai Hepatoportoenterostomy.

Exclusion Criteria:

• Patients with BA and malrotation

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Biliary Atresia

Intervention

Device:
• CoSeal spray

Locations

Country	Name	City	State
United Kingdom	Khalid Sharif	Birmingham Children's Hospital
United Kingdom	Mark Davenport	Kings College Hospital, London
United Kingdom	Leeds General Infirmary	Leeds	West Yorkshire

Sponsors (2)

Lead Sponsor	Collaborator
Naved Alizai	Baxter Healthcare Corporation

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Bowel damage		5 years	No
Other	Intra-abdominal sepsis		5 years	No
Other	Re-operation		5 years	No
Primary	Severity of Intra-abdominal adhesions	Adhesions assessed at the time of Liver transplantation	5 years	No
Secondary	Liver transplantation- blood loss		5 years	No
Secondary	Liver Transplantation- Time taken		5 years	No