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

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

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.

Study Overview

• Status: Unknown
• Conditions: Biliary Atresia
• Intervention / Treatment: Device: CoSeal spray

• Study Type: Observational
• Enrollment (Anticipated): 126

Contacts and Locations

Study Locations

• United Kingdom
  • Birmingham Children's Hospital, United Kingdom
    • Not yet recruiting
    • Khalid Sharif
    • Contact: Khalid Sharif
    • Sub-Investigator: Khalid Sharif
  • Kings College Hospital, London, United Kingdom
    • Not yet recruiting
    • Mark Davenport
    • Sub-Investigator: Mark Davenport
  • West Yorkshire
    • Leeds, West Yorkshire, United Kingdom, LS1 3EX
      • Recruiting
      • Leeds General Infirmary
      • Contact: Naved Alizai, FRCS (Paed); Phone Number: +447827307607; Email: Naved.Alizai@nhs.net
      • Principal Investigator: Naved Alizai, FRCS (Paed)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 week to 6 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

126 patients over a three year period

Description

Inclusion Criteria:

• All patients with Biliary Atresia undergoing Kasai Hepatoportoenterostomy.

Exclusion Criteria:

• Patients with BA and malrotation

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Biliary Atresia undergoing Kasai op; Randomisation for the use of CoSeal at the time of Kasai and assessment at the time of Transplantation.	Device: CoSeal spray

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of Intra-abdominal adhesions	Adhesions assessed at the time of Liver transplantation	5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Liver transplantation- blood loss	5 years
Liver Transplantation- Time taken	5 years

Other Outcome Measures

Outcome Measure	Time Frame
Bowel damage	5 years
Intra-abdominal sepsis	5 years
Re-operation	5 years

Collaborators and Investigators

• Sponsor: Naved Alizai
• Collaborators: Baxter Healthcare Corporation
• Investigators: Principal Investigator: Naved Alizai, Leeds Teaching Hospitals NHS Trust

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: December 6, 2012
• First Submitted That Met QC Criteria: December 7, 2012
• First Posted (Estimate): December 10, 2012

Study Record Updates

• Last Update Posted (Estimate): September 16, 2014
• Last Update Submitted That Met QC Criteria: September 13, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Congenital Abnormalities; Biliary Tract Diseases; Bile Duct Diseases; Digestive System Abnormalities; Biliary Atresia
• Other Study ID Numbers: NKA/LTHT/UK/CoSealRCT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No