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

Primary Purpose

Colo-rectal Cancer

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Endoscopic submucosal dissection with Purastat

About this trial

This is an interventional treatment trial for Colo-rectal Cancer focused on measuring Resection, Colorectal lesions, bleeding, ESD

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hopital Edouard HerriotRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Endoscopic submucosal dissection with Purastat

Comparative arm without Purastat

Arm Description

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.

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)

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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.

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

Number of patients requiring hemostasis, unplanned occurring within 30 days of ESD.

Rate of cases requiring transfusion related to post-ESD bleeding

Number of patients for whom at least one transfusion was ordered after the ESD

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.

Rate and duration of hospitalizations

Number of hospitalizations and number of days of hospitalization per stay within 30 days after ESD

Tolerance of PuraStat

Number of patients with at least one irritation or thromboembolic accidents.

Evaluation of the gel application time on the resection area

Time between introduction and removal of the PuraStat® catheter.

Full Information

NCT ID

NCT05031325

First Posted

August 20, 2021

Last Updated

June 17, 2022

Sponsor

Mathieu Pioche

1. Study Identification

Unique Protocol Identification Number

NCT05031325

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Recruiting

Study Start Date

February 28, 2022 (Actual)

Primary Completion Date

March 28, 2022 (Actual)

Study Completion Date

November 26, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Mathieu Pioche

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colo-rectal Cancer

Keywords

Resection, Colorectal lesions, bleeding, ESD

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

288 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Endoscopic submucosal dissection with Purastat

Arm Type

Experimental

Arm Description

Arm Title

Comparative arm without Purastat

Arm Type

No Intervention

Arm Description

Intervention Type

Device

Intervention Name(s)

Endoscopic submucosal dissection with Purastat

Intervention Description

Purastat (peptidic gel) application

Primary Outcome Measure Information:

Title

Percentage of delayed bleeding after surgery (ESD)

Description

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)

Time Frame

through study completion, an average of 2 year

Secondary Outcome Measure Information:

Title

Rate of emergency endoscopy use by risk factors for secondary bleeding

Description

Number of patients with at least one unplanned colorectal endoscopy by factors for secondary bleeding occurring within 30 days of ESD.

Time Frame

through study completion, an average of 2 year

Title

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

Description

Number of patients requiring hemostasis, unplanned occurring within 30 days of ESD.

Time Frame

through study completion, an average of 2 year

Title

Rate of cases requiring transfusion related to post-ESD bleeding

Description

Number of patients for whom at least one transfusion was ordered after the ESD

Time Frame

through study completion, an average of 2 year

Title

Rate of adverse events related to procedures (delayed perforation and stenosis) in each of the 2 arms

Description

Number of patients with at least one delayed perforation or one symptomatic stenosis.

Time Frame

through study completion, an average of 2 year

Title

Rate and duration of hospitalizations

Description

Number of hospitalizations and number of days of hospitalization per stay within 30 days after ESD

Time Frame

through study completion, an average of 2 year

Title

Tolerance of PuraStat

Description

Number of patients with at least one irritation or thromboembolic accidents.

Time Frame

through study completion, an average of 2 year

Title

Evaluation of the gel application time on the resection area

Description

Time between introduction and removal of the PuraStat® catheter.

Time Frame

During the intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mathieu PIOCHE, Pr

Phone

+ 33 4 72 11 03 43

mathieu.pioche@chu-lyon.fr

Facility Information:

Facility Name

Hopital Edouard Herriot

City

Lyon

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mathieu PIOCHE, PI

12. IPD Sharing Statement

Learn more about this trial

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

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