Colo-rectal CancerNCT05031325
Efficacy of a Hemostatic Agent (PuraStat®) in Reducing Delayed Bleeding After Endoscopic Submucosal Dissection
A study testing Endoscopic submucosal dissection with Purastat in people with Colo-rectal Cancer, run by Mathieu Pioche at 1 site in France.
Trial summary
The problem of delayed bleeding after endoscopic resection is becoming important due to the growing number of indications for anti-aggregation or anticoagulant treatment for cardiovascular reasons in the aging populations. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Colo-rectal Cancer
- What is being tested?
- Endoscopic submucosal dissection with Purastat
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- 1 siteFrance
- Study dates
- 28 Feb 2022to 26 Dec 2024
- Phase
- Interventional
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of both sexes aged 18 years or older
- Patient with a validated indication for colonoscopy for colorectal lesions
- Patients with a single colorectal lesion to be resected by ESD according to European recommendations.
- Patients with a colorectal neoplastic lesion (≥3 cm)
- Patients taking anticoagulants (acetylsalicylic acid >300 mg/day) or antiplatelet agents (clopidogrel, prasugrel, ticagrelor, clopidogrel) and managed according to European recommendations for ESD (including patients who may require heparin replacement)
- Written consent signed after clear, fair, and understood information.
- Patients with social security coverage.
Who cannot join
- Patients who may have an allergic reaction to the substances of PuraStat®.
- Patients with severe fibrosis
- Patients with a history of familial colorectal polyposis (familial adenomatous, Lynch syndrome, Peutz-Jeghers syndrome)
- Patients with a score ASA greater than or equal to 4 or 5
- Patients with a platelet count of 50,000/mm3
- Patients with acquired (non-medicated) or inherited bleeding disorders
Show all 16Show fewer
- Patients who are being treated with acetylsalicylic acid but whose treatment is discontinued at the time of the procedure (therapeutic window)
- Patients with advanced cancer or inflammatory bowel disease, including ulcerative colitis (with colonic involvement)
- Contraindication to general anesthesia
- Patients with a mental disorder, drug addiction, alcoholism, etc.
- Pregnant women or women wishing to become pregnant during the study
- Patients already participating or scheduled to participate in other clinical trials
- Lesion that has been previously resected by mucosectomy
- Patient with an initial metastatic lesion prior to colonoscopy.
- Patient unable to give personal consent
- Lack of signed informed consent
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hopital Edouard Herriot
Lyon
Mathieu PIOCHE, PI
About this study
Official title: A Multicenter Randomized Controlled Trial to Evaluate the Efficacy of a Hemostatic Agent (PuraStat®) in Reducing Delayed Bleeding After Endoscopic Colorectal Submucosal Dissection
The problem of delayed bleeding after endoscopic resection is becoming important due to the growing number of indications for anti-aggregation or anticoagulant treatment for cardiovascular reasons in the aging populations. Previous studies have shown that in patients at high risk of bleeding, the use of (PuraStat®), a simple and easily applicable solution, decreases the rate of delayed bleeding by promoting wound healing. Various preventive treatments, such as the prophylactic use of clips, have been tried to prevent the occurrence of delayed bleeding, but to date, no treatment has clearly shown its effectiveness. In addition, preventive hemostasis with clips is difficult and costly. The main objective is to compare the efficacy of PuraStat® to the standard treatment in reducing delayed bleeding after colorectal ESD in patients at high risk of delayed bleeding. The secondary objectives are to compare the same two strategies in terms of effectiveness and side effects. The primary outcome measure is the percentage of delayed bleeding at 30 days after surgery (ESD).
- Conditions
- Colo-rectal Cancer
- Being tested
- Endoscopic submucosal dissection with Purastat
- Keywords
- Resection, Colorectal lesions, bleeding, ESD
- Medical subject headings
- Colonic Neoplasms, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic submucosal dissection with PurastatDevice
Purastat (peptidic gel) application
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic submucosal dissection with Purastat | Experimental | To compare of the risk of bleeding after endoscopic submucosal dissection, after ESD, application of Purastat gel (not a drug but a device with CE mark) with a catheter of a gel on the resected area to cover the whole surface of mucosal resection. Receives: Device: Endoscopic submucosal dissection with Purastat |
| Comparative arm without Purastat | No intervention | After endoscopic submucosal dissection (ESD) and hemostasis, if the patient is randomized in the comparative group, no gel will be applied on the resected area that will remain like this without intervention (common practice) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of delayed bleeding after surgery (ESD)
Percentage of delayed bleeding is expressed primarily by the number of patients with at least one unplanned colorectal endoscopy occurring within 30 days of surgery (ESD)
Measured: through study completion, an average of 2 year
Secondary outcomes (7)
Rate of emergency endoscopy use by risk factors for secondary bleeding
Number of patients with at least one unplanned colorectal endoscopy by factors for secondary bleeding occurring within 30 days of ESD.
Measured: through study completion, an average of 2 year
Rate of emergency endoscopic hemostasis use by risk factors for secondary bleeding
Number of patients requiring hemostasis, unplanned occurring within 30 days of ESD.
Measured: through study completion, an average of 2 year
Rate of cases requiring transfusion related to post-ESD bleeding
Number of patients for whom at least one transfusion was ordered after the ESD
Measured: through study completion, an average of 2 year
Rate of adverse events related to procedures (delayed perforation and stenosis) in each of the 2 arms
Number of patients with at least one delayed perforation or one symptomatic stenosis.
Measured: through study completion, an average of 2 year
Rate and duration of hospitalizations
Number of hospitalizations and number of days of hospitalization per stay within 30 days after ESD
Measured: through study completion, an average of 2 year
Tolerance of PuraStat
Number of patients with at least one irritation or thromboembolic accidents.
Measured: through study completion, an average of 2 year
Evaluation of the gel application time on the resection area
Time between introduction and removal of the PuraStat® catheter.
Measured: During the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2021
- Study start28 Feb 2022
- Primary completion28 Feb 2022
- Study completion26 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colo-rectal CancerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 288 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mathieu Pioche
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mathieu Pioche, Société Française d'Endoscopie Digestive
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05031325
- Sponsor's protocol ID
- SFED 151
- Status last verified
- Feb 2024
- First submitted
- 20 Aug 2021
- Last updated
- 21 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Controlled Trial to Evaluate the Efficacy of a Hemostatic Agent (PuraStat®) in Reducing Delayed Bleeding After Endoscopic Colorectal Submucosal Dissection
- ClinicalTrials.gov ID
- NCT05031325
- Acronym / sponsor ID
- SFED 151
- Conditions
- Colo-rectal Cancer
- Keywords
- Resection, Colorectal lesions, bleeding, ESD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 288 participants (estimated)
- Lead sponsor
- Mathieu PiocheUniversity, hospital or other
- Study start
- 28 Feb 2022 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 26 Dec 2024 (estimated)
- First posted
- 1 Sep 2021 (actual)
- 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 problem of delayed bleeding after endoscopic resection is becoming important due to the growing number of indications for anti-aggregation or anticoagulant treatment for cardiovascular reasons in the aging populations. Previous studies have shown that in patients at high risk of bleeding, the use of (PuraStat®), a simple and easily applicable solution, decreases the rate of delayed bleeding by promoting wound healing. Various preventive treatments, such as the prophylactic use of clips, have been tried to prevent the occurrence of delayed bleeding, but to date, no treatment has clearly shown its effectiveness. In addition, preventive hemostasis with clips is difficult and costly. The main objective is to compare the efficacy of PuraStat® to the standard treatment in reducing delayed bleeding after colorectal ESD in patients at high risk of delayed bleeding. The secondary objectives are to compare the same two strategies in terms of effectiveness and side effects. The primary outcome measure is the percentage of delayed bleeding at 30 days after surgery (ESD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endoscopic submucosal dissection with Purastat | Experimental | Device: Endoscopic submucosal dissection with PurastatTo compare of the risk of bleeding after endoscopic submucosal dissection, after ESD, application of Purastat gel (not a drug but a device with CE mark) with a catheter of a gel on the resected area to cover the whole surface of mucosal resection. |
| Comparative arm without Purastat | No intervention | –After endoscopic submucosal dissection (ESD) and hemostasis, if the patient is randomized in the comparative group, no gel will be applied on the resected area that will remain like this without intervention (common practice) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients of both sexes aged 18 years or older
- Patient with a validated indication for colonoscopy for colorectal lesions
- Patients with a single colorectal lesion to be resected by ESD according to European recommendations.
- Patients with a colorectal neoplastic lesion (≥3 cm)
- Patients taking anticoagulants (acetylsalicylic acid >300 mg/day) or antiplatelet agents (clopidogrel, prasugrel, ticagrelor, clopidogrel) and managed according to European recommendations for ESD (including patients who may require heparin replacement)
Key exclusion criteria (16 listed)
- Patients who may have an allergic reaction to the substances of PuraStat®.
- Patients with severe fibrosis
- Patients with a history of familial colorectal polyposis (familial adenomatous, Lynch syndrome, Peutz-Jeghers syndrome)
- Patients with a score ASA greater than or equal to 4 or 5
- Patients with a platelet count of 50,000/mm3
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 |
|---|---|---|
| Endoscopic submucosal dissection with PurastatPurastat (peptidic gel) application | Device | Endoscopic submucosal dissection with Purastat |
Primary outcome
Percentage of delayed bleeding after surgery (ESD)
Time frame: through study completion, an average of 2 year
Percentage of delayed bleeding is expressed primarily by the number of patients with at least one unplanned colorectal endoscopy occurring within 30 days of surgery (ESD)
7 secondary outcomes
Rate of emergency endoscopy use by risk factors for secondary bleeding
Time frame: through study completion, an average of 2 year
Rate of emergency endoscopic hemostasis use by risk factors for secondary bleeding
Time frame: through study completion, an average of 2 year
Rate of cases requiring transfusion related to post-ESD bleeding
Time frame: through study completion, an average of 2 year
Rate of adverse events related to procedures (delayed perforation and stenosis) in each of the 2 arms
Time frame: through study completion, an average of 2 year
Rate and duration of hospitalizations
Time frame: through study completion, an average of 2 year
Tolerance of PuraStat
Time frame: through study completion, an average of 2 year
Evaluation of the gel application time on the resection area
Time frame: During the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic submucosal dissection with Purastat in people with Colo-rectal Cancer, run by Mathieu Pioche 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 7 inclusion and 16 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 21 Feb 2024. 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.
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?
Contact Mathieu PIOCHE, Pr (+ 33 4 72 11 03 43, mathieu.pioche@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of delayed bleeding after surgery (ESD) (time frame: through study completion, an average of 2 year). 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 21 Feb 2024.