Biliary AtresiaCoSRCTNCT01745991
Trail to Investigate the Effectiveness of CoSeal in Reducing Adhesions Following the Kasai Hepatoportoenterostomy for Biliary Atresia
An observational study of Biliary Atresia, run by Naved Alizai at 3 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 days to 6 months
- Conditions the study is for
- Biliary Atresia
- What is being tested?
- CoSeal spray
- Type of treatment
- Medical device
- How many people
- 126 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Dec 2012to Dec 2017
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 days to 6 months
- All sexes
- No healthy volunteers
- Child
Study population: 126 patients over a three year period
Who may be able to join
- All patients with Biliary Atresia undergoing Kasai Hepatoportoenterostomy.
Who cannot join
- Patients with BA and malrotation
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites, 3 recruiting
- Not yet recruiting
Khalid Sharif
Birmingham Children's Hospital
Khalid Sharif
Khalid Sharif
- Not yet recruiting
Mark Davenport
Kings College Hospital, London
Mark Davenport
- Recruiting
Leeds General Infirmary
Leeds, West Yorkshire, LS1 3EX
Naved Alizai, FRCS (Paed), +447827307607, Naved.Alizai@nhs.net
Naved Alizai, FRCS (Paed)
About this study
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.
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
- Being tested
- CoSeal spray
- Medical subject headings
- Biliary Atresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoSeal sprayDevice
| Study group | Role | What they receive |
|---|---|---|
| Biliary Atresia undergoing Kasai op | Randomisation for the use of CoSeal at the time of Kasai and assessment at the time of Transplantation. Receives: Device: CoSeal spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of Intra-abdominal adhesions
Adhesions assessed at the time of Liver transplantation
Measured: 5 years
Secondary outcomes (2)
Liver transplantation- blood loss
Measured: 5 years
Liver Transplantation- Time taken
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionDec 2015 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary AtresiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 126 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Naved Alizai
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Responsible party
- Sponsor-investigator, Naved Alizai, The Leeds Teaching Hospitals NHS Trust
- Investigators
- Naved Alizai, Principal investigator, Leeds Teaching Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01745991
- Sponsor's protocol ID
- NKA/LTHT/UK/CoSealRCT
- Acronym
- CoSRCT
- Status last verified
- Sep 2014
- First submitted
- 6 Dec 2012
- Last updated
- 16 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01745991
- Acronym / sponsor ID
- CoSRCT / NKA/LTHT/UK/CoSealRCT
- Conditions
- Biliary Atresia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Naved AlizaiUniversity, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Study start
- Dec 2012
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 10 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biliary Atresia undergoing Kasai op | – | Device: CoSeal sprayRandomisation for the use of CoSeal at the time of Kasai and assessment at the time of Transplantation. |
Who may qualify
- Ages
- 7 days to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 126 patients over a three year period
Key inclusion criteria (1 listed)
- All patients with Biliary Atresia undergoing Kasai Hepatoportoenterostomy.
Key exclusion criteria (1 listed)
- Patients with BA and malrotation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CoSeal spray | Device | Biliary Atresia undergoing Kasai op |
Primary outcome
Severity of Intra-abdominal adhesions
Time frame: 5 years
Adhesions assessed at the time of Liver transplantation
2 secondary outcomes
Liver transplantation- blood loss
Time frame: 5 years
Liver Transplantation- Time taken
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naved Alizai principal investigator
Leeds Teaching Hospitals NHS Trust
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Biliary Atresia, run by Naved Alizai at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of Intra-abdominal adhesions (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2014.