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

NCT01745991 | Unknown

• 1 other identifier: NKA/LTHT/UK/CoSealRCT
• Study Type: observational
• Target: 126
• Locations: 1 country
• Sites: 3

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.

Conditions

Biliary Atresia

Outcome Measures

Primary Outcomes (1)

• Severity of Intra-abdominal adhesions

  Adhesions assessed at the time of Liver transplantation

  5 years

Secondary Outcomes (2)

• Liver transplantation- blood loss

  5 years

• Liver Transplantation- Time taken

  5 years

Other Outcomes (3)

• Bowel damage

  5 years

• Intra-abdominal sepsis

  5 years

• Re-operation

  5 years

Study Arms (1)

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

Interventions

CoSeal spray DEVICE

Biliary Atresia undergoing Kasai op

Eligibility Criteria

• Age: 7 Days - 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

126 patients over a three year period

You may qualify if:

• All patients with Biliary Atresia undergoing Kasai Hepatoportoenterostomy.

You may not qualify if:

• Patients with BA and malrotation

Sponsors & Collaborators

• Naved Alizai: lead
• Baxter Healthcare Corporation: collaborator

Study Sites (3)

Leeds General Infirmary

Leeds, West Yorkshire, LS1 3EX, United Kingdom

RECRUITING

Khalid Sharif

Birmingham Children's Hospital, United Kingdom

NOT YET RECRUITING

Mark Davenport

Kings College Hospital, London, United Kingdom

NOT YET RECRUITING

MeSH Terms

Conditions

Biliary Atresia

Condition Hierarchy (Ancestors)

Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Digestive System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Naved Alizai

  Leeds Teaching Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Consultant Paediatric Surgeon

Study Record Dates

• First Submitted: December 6, 2012
• First Posted: December 10, 2012
• Study Start: December 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2017
• Last Updated: September 16, 2014

Record last verified: 2014-09

Locations

GB (3)