Evaluation of Nexpowder Application to Prevent Delayed Bleeding After Colorectal Endoscopic Mucosal Resection (NEXBLEED)
Colorectal Cancer
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring Colorectal polypectomy, endoscopic mucosal resection, hemostatic powder
Eligibility Criteria
Inclusion Criteria:
- More than 18 years old
- Indication of EMR for a superficial nonpedunculated colorectal lesion
Higher risk of bleeding (score GSEED RE2 ≥ 7*)
*Score GSEED RE2 (Albeniz et al GIE 2020):
- Proximal location (cecum to transverse included) : 3 points
- Antiplatelets or anticoagulation use: 3 points
- Lesion size ≥ 40 mm: 1 point
- ASA III-IV or major comorbidity: 1 point
Exclusion Criteria:
- Patients susceptible to allergic reactions to certain substances in Nexpowder
- More than one colorectal lesion
- Suspicion of invasive cancer (Kudo V, Sano IIIb, Connect III), macronodular more than 1 cm, depressed area (Paris IIc)
- Pedunculated polyps (Ip from Paris classification) or ulcerated polyps (III)
- Recurrent or residual lesion after endoscopic or surgical resection
- Poor bowel preparation quality (Boston score < 6)
- Inflammatory bowel disease (IBD)
- Patients with a platelet count of 50,000/mm3 or less
- Patients with acquired (non-medicated) or inherited bleeding disorders
- Patients with advanced cancer or inflammatory bowel disease, including ulcerative colitis (with colonic involvement)
- Contraindication to general anesthesia
- Women who are pregnant or who wish to become pregnant during the study or women who are breastfeeding.
- Children, immunocompromised persons and persons over 90 years of age
- Patients already participating or scheduled to participate in other clinical trials
- Lesion previously resected by endoscopy
- Patient with an initial metastatic lesion before colonoscopy
- Patient unable to give personal consent
- Lack of signed informed consent
Sites / Locations
- Hopital Européen Georges Pompidou, 20 Rue Leblanc
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Treated group: Nexpowder application on the scar after EMR with coagulation of visible vessels
standard procedure : EMR with coagulation of visible vessels
To compare of the risk of bleeding after EMR application of nexpower (not a drug but a device with CE mark) on the resect area (scar) to cover the whole surface of mucosal resection.
After EMR with coagulation of visible vessels, if the patient is randomized in the comparative group, not nexpowder will be applied on the scar (common practice)