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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Colo-rectal Cancer
• Intervention / Treatment: Device: Endoscopic submucosal dissection with Purastat

• Study Type: Interventional
• Enrollment (Estimated): 288
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mathieu PIOCHE, Pr; Phone Number: + 33 4 72 11 03 43; Email: mathieu.pioche@chu-lyon.fr

Study Locations

• France
  • Lyon, France
    • Recruiting
    • Hôpital Edouard Herriot
    • Contact: Mathieu PIOCHE, PI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Endoscopic submucosal dissection with Purastat; Purastat (peptidic gel) application
No Intervention: 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)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mathieu Pioche

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2022
• Primary Completion (Actual): February 28, 2022
• Study Completion (Estimated): December 26, 2024

Study Registration Dates

• First Submitted: August 20, 2021
• First Submitted That Met QC Criteria: August 26, 2021
• First Posted (Actual): September 1, 2021

Study Record Updates

• Last Update Posted (Estimated): February 21, 2024
• Last Update Submitted That Met QC Criteria: February 20, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: bleeding; ESD; Resection; Colorectal lesions
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: SFED 151

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No