Clinical trial NCT05031325: 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
Overall status: RECRUITING
Phase: NA
Conditions: Colo-rectal Cancer
Keywords: Resection
Colorectal lesions
bleeding
ESD
Lead sponsor: Société Française d'Endoscopie Digestive
Sponsor class: OTHER
First posted: 2021-09-01
Enrollment: 288
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Percentage of delayed bleeding after surgery (ESD)
timeFrame: through study completion, an average of 2 year
Secondary outcomes:
measure: Rate of emergency endoscopy use by risk factors for secondary bleeding
timeFrame: through study completion, an average of 2 year
measure: Rate of emergency endoscopic hemostasis use by risk factors for secondary bleeding
timeFrame: through study completion, an average of 2 year
measure: Rate of cases requiring transfusion related to post-ESD bleeding
timeFrame: through study completion, an average of 2 year
measure: Rate of adverse events related to procedures (delayed perforation and stenosis) in each of the 2 arms
timeFrame: through study completion, an average of 2 year
measure: Rate and duration of hospitalizations
timeFrame: through study completion, an average of 2 year
measure: Tolerance of PuraStat
timeFrame: through study completion, an average of 2 year
measure: Evaluation of the gel application time on the resection area
timeFrame: During the intervention
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hopital Edouard Herriot
Study officials:
References: