Status:
UNKNOWN
Evaluation of Nexpowder Application to Prevent Delayed Bleeding After Colorectal Endoscopic Mucosal Resection
Lead Sponsor:
Gabriel RAHMI
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
Delayed bleeding is the most frequent (5 to 15%) and challenging complication after large colorectal polypectomy. Different preventive treatments, such as the prophylactic use of clips, have been trie...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2024
Estimated Enrollment :
304 Patients enrolled
Trial Details
Trial ID
NCT05247515
Start Date
July 1 2022
End Date
August 1 2024
Last Update
February 21 2022
Active Locations (1)
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1
Hopital Européen Georges Pompidou, 20 Rue Leblanc
Paris, France, 75015