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

Colorectal Cancer Clinical Trial

— NEXBLEED  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05247515
• Other study ID #: SFED 154
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: August 1, 2024

Study information

• Verified date: February 2022
• Source: French Society of Digestive Endoscopy
• Contact: Gabriel RAHMI, MD
• Phone: +33(0)156092000
• Email: gabriel.rahmi[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 304
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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.

Locations

Country	Name	City	State
France	Hopital Européen Georges Pompidou, 20 Rue Leblanc	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Gabriel RAHMI

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The success rate of Nexpowder application	Number of patients with a satisfactory covering of the scar by the powder	Day of resection
Secondary	Delayed perforation rate	Number of patients with a presence of air and fluid into the peritoneal cavity on the CT scanner	30 days
Secondary	Stenosis rate	Number of patients with the impossibility to pass through the lumen with a standard colonoscope	30 days
Secondary	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
Secondary	Bowel obstruction rate	Number of patients with at least one symptomatic bowel obstruction.	30 days
Secondary	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
Secondary	Rate and duration of hospitalizations	Number of hospitalizations and number of days of hospitalization per stay within 30 days after EMR	30 days