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

Colo-rectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05031325
• Other study ID #: SFED 151
• Status: Recruiting
• Phase: N/A
• Start date: February 28, 2022
• Est. completion date: December 26, 2024

Study information

• Verified date: February 2024
• Source: Société Française d'Endoscopie Digestive
• Contact: Mathieu PIOCHE, Pr
• Phone: + 33 4 72 11 03 43
• Email: mathieu.pioche[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 288
• Est. completion date: December 26, 2024
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Colo-rectal Cancer
• Hemorrhage

Intervention

Device:
• Endoscopic submucosal dissection with Purastat
Purastat (peptidic gel) application

Locations

Country	Name	City	State
France	Hopital Edouard Herriot	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Mathieu Pioche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Tolerance of PuraStat	Number of patients with at least one irritation or thromboembolic accidents.	through study completion, an average of 2 year
Secondary	Evaluation of the gel application time on the resection area	Time between introduction and removal of the PuraStat® catheter.	During the intervention