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

Primary Purpose

Colorectal Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Endoscopic mucosal resection with nexpowder
Sponsored by
Gabriel RAHMI
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring Colorectal polypectomy, endoscopic mucosal resection, hemostatic powder

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hopital Européen Georges Pompidou, 20 Rue Leblanc

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

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

standard procedure : EMR with coagulation of visible vessels

Arm Description

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.

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)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 9, 2022
Last Updated
February 9, 2022
Sponsor
Gabriel RAHMI
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1. Study Identification

Unique Protocol Identification Number
NCT05247515
Brief Title
Evaluation of Nexpowder Application to Prevent Delayed Bleeding After Colorectal Endoscopic Mucosal Resection
Acronym
NEXBLEED
Official Title
Evaluation of Nexpowder Application to Prevent Delayed Bleeding After Large Colorectal Endoscopic Mucosal Resection
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2022 (Anticipated)
Primary Completion Date
August 1, 2022 (Anticipated)
Study Completion Date
August 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Gabriel RAHMI

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Colorectal polypectomy, endoscopic mucosal resection, hemostatic powder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
304 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treated group: Nexpowder application on the scar after EMR with coagulation of visible vessels
Arm Type
Experimental
Arm Description
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.
Arm Title
standard procedure : EMR with coagulation of visible vessels
Arm Type
No Intervention
Arm Description
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)
Intervention Type
Device
Intervention Name(s)
Endoscopic mucosal resection with nexpowder
Intervention Description
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.
Primary Outcome Measure Information:
Title
Severe post-resection bleeding rate up to Day 30
Description
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
Time Frame
30 days
Secondary Outcome Measure Information:
Title
The success rate of Nexpowder application
Description
Number of patients with a satisfactory covering of the scar by the powder
Time Frame
Day of resection
Title
Delayed perforation rate
Description
Number of patients with a presence of air and fluid into the peritoneal cavity on the CT scanner
Time Frame
30 days
Title
Stenosis rate
Description
Number of patients with the impossibility to pass through the lumen with a standard colonoscope
Time Frame
30 days
Title
Post coagulation syndrome
Description
Number of patients with a fever and abdominal pain without air or fluid into the peritoneal cavity on the CT scanner.
Time Frame
30 days
Title
Bowel obstruction rate
Description
Number of patients with at least one symptomatic bowel obstruction.
Time Frame
30 days
Title
Rate of cases requiring transfusion related to post-EMR bleeding
Description
Number of patients for whom at least one transfusion was ordered after the EMR
Time Frame
30 days
Title
Rate and duration of hospitalizations
Description
Number of hospitalizations and number of days of hospitalization per stay within 30 days after EMR
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gabriel RAHMI, MD
Phone
+33(0)156092000
Email
gabriel.rahmi@aphp.fr
Facility Information:
Facility Name
Hopital Européen Georges Pompidou, 20 Rue Leblanc
City
Paris
ZIP/Postal Code
75015
Country
France

12. IPD Sharing Statement

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

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