Peritoneal CarcinomatosisNCT01957852
FloSeal in CRS and HIPEC
An observational study of Peritoneal Carcinomatosis, run by Maisonneuve-Rosemont Hospital at 1 site in Canada.
Trial summary
Introduction Modern treatment of peritoneal carcinomatosis (PC) combines an aggressive cytoreductive surgery (CRS) of all macroscopic disease and hyperthermic intraperitoneal chemotherapy (HIPEC) performed at the time of surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peritoneal Carcinomatosis
- What is being tested?
- FloSeal
- How many people
- 86 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2008to Apr 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with peritoneal carcinomatosis (PC) of any cause followed at Hôpital Maisonneuve-Rosemont and undergoing Cytoreductive and HIPEC surgery
Who may be able to join
- Male and female patients older than 18 year old
- All cases of PC regardless of primary tumour (colorectal carcinoma, peritoneal mesothelioma, appendiceal carcinoma etc.)
Who cannot join
- Prophylactic HIPEC
- Peritoneal Carcinomatosis Index (PCI) < 5
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can FloSeal Reduce the Risk of Intra-abdominal Bleeding After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy Performed for the Treatment of Peritoneal Carcinomatosis ?
Introduction
Modern treatment of peritoneal carcinomatosis (PC) combines an aggressive cytoreductive surgery (CRS) of all macroscopic disease and hyperthermic intraperitoneal chemotherapy (HIPEC) performed at the time of surgery. It is considered a high risk procedure and post-operative intra-abdominal bleeding is a major issue as it can delay recovery and promote intra-abdominal infections. In most severe cases (10 to 20% of patients), a second surgery to control the bleeding will be necessary. Major causes of bleeding are : radical resection, extensive peritonectomy, length of surgery, massive transfusion and use of HIPEC.
Read more
To reduce the risk of intra-abdominal hemorrhage, many strategies have been tried and one of these is the liberal use of FloSeal, but there is no data in this particular field of interest. Over the last 18 months, the investigators have started to use FloSeal in all their cases with large PC and they have observed a dramatic reduction in the rate of reoperation for bleeding and probably secondarily, in the use of blood products, but this has not been measured.
Hypothesis
FloSeal can reduce the risk of bleeding after CRS and HIPEC procedure.
Primary objective
To evaluate if the use of FloSeal can reduce the risk of reoperation after CRS and HIPEC procedure in the treatment of PC.
Secondary objectives
- To evaluate if the use of FloSeal can reduce operative blood loss.
- To evaluate if the use of FloSeal can reduce the need of blood products after CRS and HIPEC procedure.
- To evaluate if the use of FloSeal can have an impact on other common surgical complications (which can be indirectly bleeding related).
- To evaluate if the use of FloSeal can have an impact on length of hospital stay.
- Conditions
- Peritoneal Carcinomatosis
- Being tested
- FloSeal
- Medical subject headings
- Peritoneal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FloSealOther
Also called gelatin matrix thrombin solution (Baxter)
| Study group | Role | What they receive |
|---|---|---|
| FloSeal + | Routine use of Floseal during cytoreductive and HIPEC surgery Receives: Other: FloSeal | |
| FloSeal - | FloSeal not used during CRS and HIPEC procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reoperation rate for intra-abdominal bleeding after CRS and HIPEC
Measured: postoperative day O to hospital discharge (an expected average of 3 weeks after surgery)
Secondary outcomes (5)
operative blood loss
Measured: Cytoreductive and HIPEC surgery
Blood products use
packed red blood cells, fresh frozen plasma, platelets, specific coagulation factors and cryoprecipitates
Measured: during cytoreductive and HIPEC surgery and post-operative hospital stay (an expected average of 3 weeks)
Hemoglobin rate
Measured: at hospital discharge (an expected average of 3 weeks)
Non-hemorrhagic complications
According to the Dindo-Clavien postoperative complications classification
Measured: postoperative day 0 to hospital discharge (an expected average of 3 weeks after surgery)
Length of hospital stay
Hospital discharge is defined in our study as medical discharge
Measured: postoperative day 0 to hospital discharge (an expected average of 3 weeks after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startJan 2008
- Primary completionMar 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal CarcinomatosisStudies 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
- Retrospective
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maisonneuve-Rosemont Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pierre Dubé, Maisonneuve-Rosemont Hospital
- Investigators
- Pierre Dubé, Principal investigator, Maisonneuve-Rosemont Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01957852
- Sponsor's protocol ID
- 13019
- Status last verified
- Feb 2015
- First submitted
- 21 May 2013
- Last updated
- 25 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can FloSeal Reduce the Risk of Intra-abdominal Bleeding After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy Performed for the Treatment of Peritoneal Carcinomatosis ?
- ClinicalTrials.gov ID
- NCT01957852
- Acronym / sponsor ID
- 13019
- Conditions
- Peritoneal Carcinomatosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Maisonneuve-Rosemont HospitalUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Mar 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 8 Oct 2013 (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.
Introduction
Modern treatment of peritoneal carcinomatosis (PC) combines an aggressive cytoreductive surgery (CRS) of all macroscopic disease and hyperthermic intraperitoneal chemotherapy (HIPEC) performed at the time of surgery. It is considered a high risk procedure and post-operative intra-abdominal bleeding is a major issue as it can delay recovery and promote intra-abdominal infections. In most severe cases (10 to 20% of patients), a second surgery to control the bleeding will be necessary. Major causes of bleeding are : radical resection, extensive peritonectomy, length of surgery, massive transfusion and use of HIPEC.
To reduce the risk of intra-abdominal hemorrhage, many strategies have been tried and one of these is the liberal use of FloSeal, but there is no data in this particular field of interest. Over the last 18 months, the investigators have started to use FloSeal in all their cases with large PC and they have observed a dramatic reduction in the rate of reoperation for bleeding and probably secondarily, in the use of blood products, but this has not been measured.
Hypothesis
FloSeal can reduce the risk of bleeding after CRS and HIPEC procedure.
Primary objective
To evaluate if the use of FloSeal can reduce the risk of reoperation after CRS and HIPEC procedure in the treatment of PC.
Secondary objectives
- To evaluate if the use of FloSeal can reduce operative blood loss.
- To evaluate if the use of FloSeal can reduce the need of blood products after CRS and HIPEC procedure.
- To evaluate if the use of FloSeal can have an impact on other common surgical complications (which can be indirectly bleeding related).
- To evaluate if the use of FloSeal can have an impact on length of hospital stay.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FloSeal + | – | Other: FloSealRoutine use of Floseal during cytoreductive and HIPEC surgery |
| FloSeal - | – | –FloSeal not used during CRS and HIPEC procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with peritoneal carcinomatosis (PC) of any cause followed at Hôpital Maisonneuve-Rosemont and undergoing Cytoreductive and HIPEC surgery
Key inclusion criteria (2 listed)
- Male and female patients older than 18 year old
- All cases of PC regardless of primary tumour (colorectal carcinoma, peritoneal mesothelioma, appendiceal carcinoma etc.)
Key exclusion criteria (2 listed)
- Prophylactic HIPEC
- Peritoneal Carcinomatosis Index (PCI) < 5
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 |
|---|---|---|
| FloSealAlso: gelatin matrix thrombin solution (Baxter) | Other | FloSeal + |
Primary outcome
Reoperation rate for intra-abdominal bleeding after CRS and HIPEC
Time frame: postoperative day O to hospital discharge (an expected average of 3 weeks after surgery)
5 secondary outcomes
operative blood loss
Time frame: Cytoreductive and HIPEC surgery
Blood products use
Time frame: during cytoreductive and HIPEC surgery and post-operative hospital stay (an expected average of 3 weeks)
Hemoglobin rate
Time frame: at hospital discharge (an expected average of 3 weeks)
Non-hemorrhagic complications
Time frame: postoperative day 0 to hospital discharge (an expected average of 3 weeks after surgery)
Length of hospital stay
Time frame: postoperative day 0 to hospital discharge (an expected average of 3 weeks after surgery)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2015.
Related trials for Peritoneal Carcinomatosis
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Combined Systemic and Intraperitoneal Chemotherapy for Synchronous Gastric and/or Gastroesophageal Peritoneal Carcinomatosis
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Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Associated With Systemic Chemotherapy in Women With Advanced Ovarian Cancer
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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.
Pierre Dubé principal investigator
Maisonneuve-Rosemont Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peritoneal Carcinomatosis, run by Maisonneuve-Rosemont Hospital at 1 site in Canada.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 25 Feb 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Reoperation rate for intra-abdominal bleeding after CRS and HIPEC (time frame: postoperative day O to hospital discharge (an expected average of 3 weeks after surgery)). 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 25 Feb 2015.