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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by The Leeds Teaching Hospitals NHS Trust
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Naved Alizai, The Leeds Teaching Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT01745991
First received: December 6, 2012
Last updated: September 13, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
Biliary Atresia
Device: CoSeal spray

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
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.

Resource links provided by NLM:


Further study details as provided by The Leeds Teaching Hospitals NHS Trust:

Primary Outcome Measures:
  • Severity of Intra-abdominal adhesions [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Adhesions assessed at the time of Liver transplantation


Secondary Outcome Measures:
  • Liver transplantation- blood loss [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Liver Transplantation- Time taken [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Bowel damage [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Intra-abdominal sepsis [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Re-operation [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 126
Study Start Date: December 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   up to 6 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

126 patients over a three year period

Criteria

Inclusion Criteria:

  • All patients with Biliary Atresia undergoing Kasai Hepatoportoenterostomy.

Exclusion Criteria:

  • Patients with BA and malrotation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01745991

Locations
United Kingdom
Leeds General Infirmary Recruiting
Leeds, West Yorkshire, United Kingdom, LS1 3EX
Contact: Naved Alizai, FRCS (Paed)    +447827307607    Naved.Alizai@nhs.net   
Principal Investigator: Naved Alizai, FRCS (Paed)         
Khalid Sharif Not yet recruiting
Birmingham Children's Hospital, United Kingdom
Contact: Khalid Sharif         
Sub-Investigator: Khalid Sharif         
Mark Davenport Not yet recruiting
Kings College Hospital, London, United Kingdom
Sub-Investigator: Mark Davenport         
Sponsors and Collaborators
Naved Alizai
Baxter Healthcare Corporation
Investigators
Principal Investigator: Naved Alizai Leeds Teaching Hospitals NHS TRust
  More Information

No publications provided

Responsible Party: Naved Alizai, Consultant Paediatric Surgeon, The Leeds Teaching Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT01745991     History of Changes
Other Study ID Numbers: NKA/LTHT/UK/CoSealRCT
Study First Received: December 6, 2012
Last Updated: September 13, 2014
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Biliary Atresia
Bile Duct Diseases
Biliary Tract Diseases
Congenital Abnormalities
Digestive System Abnormalities
Digestive System Diseases

ClinicalTrials.gov processed this record on October 20, 2014