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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Colorectal Cancer
• Intervention / Treatment: Device: Endoscopic mucosal resection with nexpowder

• Study Type: Interventional
• Enrollment (Anticipated): 304
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gabriel RAHMI, MD; Phone Number: +33(0)156092000; Email: gabriel.rahmi@aphp.fr

Study Locations

• France
  • Paris, France, 75015
    • Hopital Européen Georges Pompidou, 20 Rue Leblanc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treated group: Nexpowder application on the scar after 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.	Device: Endoscopic 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.
No Intervention: standard procedure : EMR with coagulation of visible vessels; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severe post-resection bleeding rate up to Day 30	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	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The success rate of Nexpowder application	Number of patients with a satisfactory covering of the scar by the powder	Day of resection
Delayed perforation rate	Number of patients with a presence of air and fluid into the peritoneal cavity on the CT scanner	30 days
Stenosis rate	Number of patients with the impossibility to pass through the lumen with a standard colonoscope	30 days
Post coagulation syndrome	Number of patients with a fever and abdominal pain without air or fluid into the peritoneal cavity on the CT scanner.	30 days
Bowel obstruction rate	Number of patients with at least one symptomatic bowel obstruction.	30 days
Rate of cases requiring transfusion related to post-EMR bleeding	Number of patients for whom at least one transfusion was ordered after the EMR	30 days
Rate and duration of hospitalizations	Number of hospitalizations and number of days of hospitalization per stay within 30 days after EMR	30 days

Collaborators and Investigators

• Sponsor: Gabriel RAHMI

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2022
• Primary Completion (Anticipated): August 1, 2022
• Study Completion (Anticipated): August 1, 2024

Study Registration Dates

• First Submitted: February 9, 2022
• First Submitted That Met QC Criteria: February 9, 2022
• First Posted (Actual): February 21, 2022

Study Record Updates

• Last Update Posted (Actual): February 21, 2022
• Last Update Submitted That Met QC Criteria: February 9, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: endoscopic mucosal resection; hemostatic powder; Colorectal polypectomy
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: SFED 154

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No