Clinical trial NCT01745991: Trail to Investigate the Effectiveness of CoSeal in Reducing Adhesions Following the Kasai Hepatoportoenterostomy for Biliary Atresia
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.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Biliary Atresia
Lead sponsor: The Leeds Teaching Hospitals NHS Trust
Sponsor class: OTHER
Collaborators: name: Baxter Healthcare Corporation
First posted: 2012-12-10
Enrollment: 126
Sex: ALL
Minimum age (years): 7
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 126 patients over a three year period

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.


Eligibility criteria: Inclusion Criteria:

* All patients with Biliary Atresia undergoing Kasai Hepatoportoenterostomy.

Exclusion Criteria:

* Patients with BA and malrotation

Primary outcomes:
measure: Severity of Intra-abdominal adhesions
timeFrame: 5 years
Secondary outcomes:
measure: Liver transplantation- blood loss
timeFrame: 5 years
measure: Liver Transplantation- Time taken
timeFrame: 5 years
Other outcomes:
measure: Bowel damage
timeFrame: 5 years
measure: Intra-abdominal sepsis
timeFrame: 5 years
measure: Re-operation
timeFrame: 5 years
Locations:
city: Leeds
country: United Kingdom
facility: Leeds General Infirmary
state: West Yorkshire
city: Birmingham Children's Hospital
country: United Kingdom
facility: Khalid Sharif
city: Kings College Hospital, London
country: United Kingdom
facility: Mark Davenport
Study officials:
affiliation: Leeds Teaching Hospitals NHS Trust
name: Naved Alizai
role: PRINCIPAL_INVESTIGATOR
References: