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

Mathieu Pioche

Status: Enrolling

Conditions: Colo-rectal Cancer

Treatments: Device: Endoscopic submucosal dissection with Purastat

Study type: Interventional

Funder types: Other

Identifiers

NCT05031325

SFED 151

Details and patient eligibility

About

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).

Enrollment: 288 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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288 participants in 2 patient groups

Endoscopic submucosal dissection with Purastat

Experimental group

Description:

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.

Treatment:

Device: Endoscopic submucosal dissection with Purastat

Comparative arm without Purastat

No Intervention group

Description:

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)