COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

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. Identifier: NCT01745991
Recruitment Status : Unknown
Verified September 2014 by Naved Alizai, The Leeds Teaching Hospitals NHS Trust.
Recruitment status was:  Recruiting
First Posted : December 10, 2012
Last Update Posted : September 16, 2014
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Naved Alizai, The Leeds Teaching Hospitals NHS Trust

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.

Condition or disease Intervention/treatment
Biliary Atresia Device: CoSeal spray

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 126 participants
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.
Study Start Date : December 2012
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adhesions

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

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

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

Other Outcome Measures:
  1. Bowel damage [ Time Frame: 5 years ]
  2. Intra-abdominal sepsis [ Time Frame: 5 years ]
  3. Re-operation [ Time Frame: 5 years ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
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

Inclusion Criteria:

  • All patients with Biliary Atresia undergoing Kasai Hepatoportoenterostomy.

Exclusion Criteria:

  • Patients with BA and malrotation

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 identifier (NCT number): NCT01745991

Layout table for location information
United Kingdom
Leeds General Infirmary Recruiting
Leeds, West Yorkshire, United Kingdom, LS1 3EX
Contact: Naved Alizai, FRCS (Paed)    +447827307607   
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
Layout table for investigator information
Principal Investigator: Naved Alizai Leeds Teaching Hospitals NHS Trust
Additional Information:

Layout table for additonal information
Responsible Party: Naved Alizai, Consultant Paediatric Surgeon, The Leeds Teaching Hospitals NHS Trust Identifier: NCT01745991    
Other Study ID Numbers: NKA/LTHT/UK/CoSealRCT
First Posted: December 10, 2012    Key Record Dates
Last Update Posted: September 16, 2014
Last Verified: September 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
Biliary Atresia
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Digestive System Abnormalities
Congenital Abnormalities