Evaluation of Nexpowder Application to Prevent Delayed Bleeding After Colorectal Endoscopic Mucosal Resection

Not Applicable

• Conditions: Colorectal Cancer
• Interventions: Device: Endoscopic mucosal resection with nexpowder

• Registration Number: NCT05247515
• Lead Sponsor: Gabriel RAHMI

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-02
• Study First Submitted: 2022-02-09
• Study First Submitted QC: 2022-02-09
• Last Update Submitted: 2022-02-09
• Study First Posted: 2022-02-21
• Last Update Posted: 2022-02-21
• Study Start: 2022-07-01
• Primary Completion: 2022-08-01
• Study Completion: 2024-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 304

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treated group: Nexpowder application on the scar after EMR with coagulation of visible vessels	Endoscopic mucosal resection with nexpowder	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Rate and duration of hospitalizations	30 days	Number of hospitalizations and number of days of hospitalization per stay within 30 days after EMR
Stenosis rate	30 days	Number of patients with the impossibility to pass through the lumen with a standard colonoscope
Bowel obstruction rate	30 days	Number of patients with at least one symptomatic bowel obstruction.
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
Delayed perforation rate	30 days	Number of patients with a presence of air and fluid into the peritoneal cavity on the CT scanner
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

Trial Locations

Locations (1)

Hopital Européen Georges Pompidou, 20 Rue Leblanc; 🇫🇷 Paris, France