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

  • STATUS
    Recruiting
  • End date
    Nov 26, 2023
  • participants needed
    288
  • sponsor
    Mathieu Pioche
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Updated on 9 July 2022
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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).

Details
Condition Colo-rectal Cancer
Treatment Endoscopic submucosal dissection with Purastat
Clinical Study IdentifierNCT05031325
SponsorMathieu Pioche
Last Modified on9 July 2022

Eligibility

 Yes No Not Sure

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
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