Colorectal Cancer
Conditions
Keywords
Colorectal polypectomy, endoscopic mucosal resection, hemostatic powder
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 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. A newly developed endoscopic hemostatic powder generating gelation effect (Nexpowder) may be an effective alternative to prevent post polypectomy bleeding in patients treated by endoscopic mucosal resection (EMR) for large superficial colorectal lesions.
Interventions
DEVICEEndoscopic mucosal resection with nexpowder
At the end of the EMR procedure, the patient will be randomized. In the treated group, Nexpowder will be sprayed thanks to a catheter inserted through the operating channel of the endoscope.
Sponsors
Gabriel RAHMI
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severe post-resection bleeding rate up to Day 30 | 30 days | Number of patients with a severe post-resection bleeding. It is defined as bleeding requiring a new endoscopy or surgery, OR a radiological embolization, OR blood transfusion, OR a re-hospitalization OR haematochezia with hemoglobin loss \> 2 g/dl |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Delayed perforation rate | 30 days | Number of patients with a presence of air and fluid into the peritoneal cavity on the CT scanner |
| Stenosis rate | 30 days | Number of patients with the impossibility to pass through the lumen with a standard colonoscope |
| Post coagulation syndrome | 30 days | Number of patients with a fever and abdominal pain without air or fluid into the peritoneal cavity on the CT scanner. |
| The success rate of Nexpowder application | Day of resection | Number of patients with a satisfactory covering of the scar by the powder |
| Rate of cases requiring transfusion related to post-EMR bleeding | 30 days | Number of patients for whom at least one transfusion was ordered after the EMR |
| Rate and duration of hospitalizations | 30 days | Number of hospitalizations and number of days of hospitalization per stay within 30 days after EMR |
| Bowel obstruction rate | 30 days | Number of patients with at least one symptomatic bowel obstruction. |
Countries
France
Contacts
Primary ContactGabriel RAHMI, MD
Outcome results
None listed