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

Launched by MATHIEU PIOCHE · Aug 26, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called PuraStat® to see if it can help reduce the risk of delayed bleeding after a procedure called endoscopic submucosal dissection (ESD), which is used to remove colorectal lesions, especially in patients with colon cancer. Delayed bleeding can be a serious issue, particularly for older patients who are on blood-thinning medications for heart problems. The goal is to compare how well PuraStat® works compared to the standard treatment in preventing this bleeding.

To participate in the trial, you need to be at least 18 years old and scheduled for a colonoscopy to remove a specific type of colorectal lesion that’s larger than 3 cm. You should also be on certain blood-thinning medications. If you're interested, you’ll receive clear information about the trial to help you decide if you want to participate. Throughout the study, you'll be monitored for any side effects and the occurrence of delayed bleeding for up to 30 days after the procedure. This trial is currently recruiting participants, and your involvement could help improve treatments for others in the future.

Gender

ALL

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