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

Study Overview
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Brief Summary
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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).

Official Title
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A Multicenter Randomized Controlled Trial to Evaluate the Efficacy of a Hemostatic Agent (PuraStat®) in Reducing Delayed Bleeding After Endoscopic Colorectal Submucosal Dissection

Conditions
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Colo-rectal Cancer

Intervention / Treatment
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* Device: Endoscopic submucosal dissection with Purastat


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endoscopic submucosal dissection with Purastat<br>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. | Device: Endoscopic submucosal dissection with Purastat<br>* Purastat (peptidic gel) application<br>|
| No Intervention: Comparative arm without Purastat<br>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 the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | through study completion, an average of 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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 | 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. | 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 | through study completion, an average of 2 year | 
| Tolerance of PuraStat | Number of patients with at least one irritation or thromboembolic accidents. | 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. | During the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Resection, Colorectal lesions, bleeding, ESD