Efficacy of a Hemostatic Agent (PuraStat®) in Reducing Delayed Bleeding After Endoscopic Submucosal Dissection

NCT ID: NCT05031325

Last Updated: 2024-02-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 288 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-28
• Study Completion Date: 2024-12-26

Brief 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. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Endoscopic submucosal dissection with Purastat

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.

Group Type: EXPERIMENTAL

Endoscopic submucosal dissection with Purastat

Intervention Type: DEVICE

Purastat (peptidic gel) application

Comparative arm without Purastat

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)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Endoscopic submucosal dissection with Purastat

Purastat (peptidic gel) application

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mathieu Pioche

OTHER

Sponsor Role: lead

Responsible Party

Mathieu Pioche

Principal Investagator, Medical Doctor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Hopital Edouard Herriot

Lyon, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Mathieu PIOCHE, Pr

Role: CONTACT

mathieu.pioche@chu-lyon.fr

+ 33 4 72 11 03 43

Facility Contacts

Mathieu PIOCHE, PI

Role: primary

Other Identifiers

SFED 151

Identifier Type: -

Identifier Source: org_study_id