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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2014 by Naved Alizai, The Leeds Teaching Hospitals NHS Trust.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01745991
First Posted: December 10, 2012
Last Update Posted: September 16, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Naved Alizai, The Leeds Teaching Hospitals NHS Trust
  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 Naved Alizai, The Leeds Teaching Hospitals NHS Trust:

Primary Outcome Measures:
  • Severity of Intra-abdominal adhesions [ Time Frame: 5 years ]
    Adhesions assessed at the time of Liver transplantation


Secondary Outcome Measures:
  • Liver transplantation- blood loss [ Time Frame: 5 years ]
  • Liver Transplantation- Time taken [ Time Frame: 5 years ]

Other Outcome Measures:
  • Bowel damage [ Time Frame: 5 years ]
  • Intra-abdominal sepsis [ Time Frame: 5 years ]
  • Re-operation [ Time Frame: 5 years ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: December 6, 2012
First Posted: December 10, 2012
Last Update Posted: September 16, 2014
Last Verified: September 2014

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