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

NCT05247515 | Unknown

• 1 other identifier: SFED 154
• Study Type: interventional
• Target: 304
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Keywords

Colorectal polypectomy; endoscopic mucosal resection; hemostatic powder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• The success rate of Nexpowder application

  Day of resection

• Delayed perforation rate

  30 days

• Stenosis rate

  30 days

• Post coagulation syndrome

  30 days

• Bowel obstruction rate

  30 days

Study Arms (2)

Treated group: Nexpowder application on the scar after EMR with coagulation of visible vessels

EXPERIMENTAL

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

standard procedure : EMR with coagulation of visible vessels

NO INTERVENTION

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)

Interventions

Endoscopic mucosal resection with nexpowder DEVICE

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.

Treated group: Nexpowder application on the scar after EMR with coagulation of visible vessels

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gabriel RAHMI: lead

Study Sites (1)

Hopital Européen Georges Pompidou, 20 Rue Leblanc

Paris, 75015, France

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Endoscopic Mucosal Resection

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Central Study Contacts

Gabriel RAHMI, MD

CONTACT

+33(0)156092000; gabriel.rahmi@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investagator, Medical Doctor

Study Record Dates

• First Submitted: February 9, 2022
• First Posted: February 21, 2022
• Study Start: July 1, 2022
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2024
• Last Updated: February 21, 2022

Record last verified: 2022-02

Locations

FR (1)