Patient With Hepatic MetastasisPhase 2/3COLIBISNCT01121601
CoSeal in Liver and Biliary Surgery in Prevention of Denovo Hepatic Adhesion
A Phase 2/3 study testing hepatic surgery of resection in people with Patient With Hepatic Metastasis, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
Study of phase II: Clinical study national, exploratory, multicentric, prospective, randomized, as a double blind man evaluating the effectiveness and the tolerance of the treatment by a surgical gel of sealing containing polyethylene glycol in the prevention of operational adherences post.3 Study of phase III… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Patient With Hepatic Metastasis
- What is being tested?
- hepatic surgery of resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2011to not given
- Phase
- Phase 2/3
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Major patients.
- Hepatic Carriers of metastases.
- Eligible with a procedure of surgical eradication in two brought closer times (time lower than 3 months).
- Strategy validated in multidisciplinary meeting of cancerology.
- Enlightened Assent given and signed before the intervention.
Who cannot join
- Anaesthetic Counter-indications with a procedure in two times
- Carcinose péritonéale, reached metastatic not éradicable
- Over-sensitiveness or allergy known to polyethylene CoSeal glycol
- Concomitant Use of another antiblocking agent
- Immunodéprimés Patients or taking drugs immunodépresseurs with the long court like the corticosteroids,
- Impossibility of subjecting itself to the medical monitoring imposed by the study for reasons geographical, social, psychic or medical.
- Concomitant Participation in another clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness and Tolerance of CoSeal in the Prevention of Hepatic Adherences of Novo Post Operational Within the Framework of a Hepatic Surgery of Resection in Two Times for Hepatic Metastases: Study of Phase II/III.
Study of phase II: Clinical study national, exploratory, multicentric, prospective, randomized, as a double blind man evaluating the effectiveness and the tolerance of the treatment by a surgical gel of sealing containing polyethylene glycol in the prevention of operational adherences post.3 Study of phase III: Clinical study national, multicentric, prospective, randomized, controlled, as a double blind man comparing a group controls with a group of patients treated by a surgical gel of sealing containing polyethylene glycol in the prevention of hepatic adherences of novo post operational.
- Conditions
- Patient With Hepatic Metastasis
- Being tested
- hepatic surgery of resection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hepatic surgery of resectionProcedure or surgery
after metastasis liver resection , Coseal will be administered at 4 mL by dose, administration of 1 to 3 dose in fontion of liver adherence Coseal will be administered by spray at 5 to 10 cm of liver.
hepatic surgery of resectionProcedure or surgery
this is a liver metastasis resection according to liver chirurgical guidelines study drug not administered in this group
| Study group | Role | What they receive |
|---|---|---|
| Group COSEAL | Experimental | Not described Receives: Procedure: hepatic surgery of resection |
| Reference group | Active comparator | Not described Receives: Procedure: hepatic surgery of resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
HEPATIC ADHERENCE SEVERITY
Measure of hepatic adherence :
SCORE 0: NO HEPATIC ADHERENCE SCORE 1: SHADOW ON HEPATIC ADHERENCE SCORE 2: VASCULAR OR DENSE HEPATIC ADHERENCE SCORE 3:COHESIVE HEPATIC ADHERENCE SCORE 4: DISSECTION IN ANOTHER PLAN
THIS 5 SCORE WILL BE ANALYSED ON THE 8 SEGMENT AND ON PEDICLE OF LIVER
Measured: 3 years
Secondary outcomes (12)
LIVER RELEASE VALUE
DISSECTION PHASE BETWEEN INCISION AND PARTIAL OR TOTAL EXPOSITION OF LIVER
Measured: 3 years
LOSS OF BLOOD
Measured: 3 years
CoSeal tolerance
Measured: 3 years
per operative complication
Measured: 3 years
post operative complication
Measured: 3 years
hospitalisation time
Measured: 3 years
operative difficulty
score 0 if there are no difficulty for the release of liver or score 10 if dissection of liver is impossible
Measured: 3 years
de novo hepatic adherence extension
0 : no extension of hepatic adherence
- : 1/3 of area affected
- : between 1/3 and 2/3 of area affected
- : more than 2/3 of area affected
Measured: 3 years
hepatic adherence reformation
Measured: 3 years
adherence composite score
this is a mathematic score in relation with area and severity of liver adherence
Measured: 3 years
composite score and surgery difficulty
this is a correlation between the composite score, the morbidity criteria and dissection difficulty
Measured: 3 years
liver adherence score validation
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2010 (estimated)
- Study startAug 2011
Why it stopped: Practices in surgery have evolved and the study has not interest yet
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient With Hepatic MetastasisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bruno HEYD, PU-PH, Principal investigator, CHU Besançon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01121601
- Sponsor's protocol ID
- P/2010/94
- Acronym
- COLIBIS
- Status last verified
- Aug 2015
- First submitted
- 4 May 2010
- Last updated
- 6 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Tolerance of CoSeal in the Prevention of Hepatic Adherences of Novo Post Operational Within the Framework of a Hepatic Surgery of Resection in Two Times for Hepatic Metastases: Study of Phase II/III.
- ClinicalTrials.gov ID
- NCT01121601
- Acronym / sponsor ID
- COLIBIS / P/2010/94
- Conditions
- Patient With Hepatic Metastasis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Practices in surgery have evolved and the study has not interest yet
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Aug 2011
- First posted
- 12 May 2010 (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.
Study of phase II: Clinical study national, exploratory, multicentric, prospective, randomized, as a double blind man evaluating the effectiveness and the tolerance of the treatment by a surgical gel of sealing containing polyethylene glycol in the prevention of operational adherences post.3 Study of phase III: Clinical study national, multicentric, prospective, randomized, controlled, as a double blind man comparing a group controls with a group of patients treated by a surgical gel of sealing containing polyethylene glycol in the prevention of hepatic adherences of novo post operational.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group COSEAL | Experimental | Procedure: hepatic surgery of resection |
| Reference group | Active comparator | Procedure: hepatic surgery of resection |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Major patients.
- Hepatic Carriers of metastases.
- Eligible with a procedure of surgical eradication in two brought closer times (time lower than 3 months).
- Strategy validated in multidisciplinary meeting of cancerology.
- Enlightened Assent given and signed before the intervention.
Key exclusion criteria (7 listed)
- Anaesthetic Counter-indications with a procedure in two times
- Carcinose péritonéale, reached metastatic not éradicable
- Over-sensitiveness or allergy known to polyethylene CoSeal glycol
- Concomitant Use of another antiblocking agent
- Immunodéprimés Patients or taking drugs immunodépresseurs with the long court like the corticosteroids,
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 |
|---|---|---|
| hepatic surgery of resectionafter metastasis liver resection , Coseal will be administered at 4 mL by dose, administration of 1 to 3 dose in fontion of liver adherence Coseal will be administered by spray at 5 to 10 cm of liver. | Procedure or surgery | Group COSEAL |
| hepatic surgery of resectionthis is a liver metastasis resection according to liver chirurgical guidelines study drug not administered in this group | Procedure or surgery | Reference group |
Primary outcome
HEPATIC ADHERENCE SEVERITY
Time frame: 3 years
Measure of hepatic adherence : SCORE 0: NO HEPATIC ADHERENCE SCORE 1: SHADOW ON HEPATIC ADHERENCE SCORE 2: VASCULAR OR DENSE HEPATIC ADHERENCE SCORE 3:COHESIVE HEPATIC ADHERENCE SCORE 4: DISSECTION IN ANOTHER PLAN THIS 5 SCORE WILL BE ANALYSED ON THE 8 SEGMENT AND ON PEDICLE OF LIVER
12 secondary outcomes
LIVER RELEASE VALUE
Time frame: 3 years
LOSS OF BLOOD
Time frame: 3 years
CoSeal tolerance
Time frame: 3 years
per operative complication
Time frame: 3 years
post operative complication
Time frame: 3 years
hospitalisation time
Time frame: 3 years
operative difficulty
Time frame: 3 years
de novo hepatic adherence extension
Time frame: 3 years
hepatic adherence reformation
Time frame: 3 years
adherence composite score
Time frame: 3 years
composite score and surgery difficulty
Time frame: 3 years
liver adherence score validation
Time frame: 3 years
Results and safety
The study was stopped early (reason given: Practices in surgery have evolved and the study has not interest yet). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2015.
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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.
Bruno HEYD, PU-PH principal investigator
CHU Besançon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing hepatic surgery of resection in people with Patient With Hepatic Metastasis, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
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 5 inclusion and 7 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: stopped early, as of the sponsor's last update on 6 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Practices in surgery have evolved and the study has not interest yet). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HEPATIC ADHERENCE SEVERITY (time frame: 3 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 6 Aug 2015.