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

NCT05031325 | Recruiting

• 1 other identifier: SFED 151
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Colo-rectal Cancer

Keywords

Resection; Colorectal lesions; bleeding; ESD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Rate of emergency endoscopy use by risk factors for secondary bleeding

  through study completion, an average of 2 year

• Rate of emergency endoscopic hemostasis use by risk factors for secondary bleeding

  through study completion, an average of 2 year

• Rate of cases requiring transfusion related to post-ESD bleeding

  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

  through study completion, an average of 2 year

• Rate and duration of hospitalizations

  through study completion, an average of 2 year

Study Arms (2)

Endoscopic submucosal dissection with Purastat

EXPERIMENTAL

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

Comparative arm without Purastat

NO INTERVENTION

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)

Interventions

Endoscopic submucosal dissection with Purastat DEVICE

Purastat (peptidic gel) application

Endoscopic submucosal dissection with Purastat

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mathieu Pioche: lead

Study Sites (1)

Hopital Edouard Herriot

Lyon, France

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms; Hemorrhage

Interventions

Endoscopic Mucosal Resection

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Central Study Contacts

Mathieu PIOCHE, Pr

CONTACT

+ 33 4 72 11 03 43; mathieu.pioche@chu-lyon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investagator, Medical Doctor

Study Record Dates

• First Submitted: August 20, 2021
• First Posted: September 1, 2021
• Study Start: February 28, 2022
• Primary Completion: February 28, 2022
• Study Completion: December 26, 2024
• Last Updated: February 21, 2024

Record last verified: 2024-02

Locations

FR (1)