Clinical trial NCT05247515: Evaluation of Nexpowder Application to Prevent Delayed Bleeding After Colorectal Endoscopic Mucosal Resection
Official title: Evaluation of Nexpowder Application to Prevent Delayed Bleeding After Large Colorectal Endoscopic Mucosal Resection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Cancer
Keywords: Colorectal polypectomy
endoscopic mucosal resection
hemostatic powder
Lead sponsor: French Society of Digestive Endoscopy
Sponsor class: OTHER
First posted: 2022-02-21
Enrollment: 304
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Severe post-resection bleeding rate up to Day 30
timeFrame: 30 days
Secondary outcomes:
measure: The success rate of Nexpowder application
timeFrame: Day of resection
measure: Delayed perforation rate
timeFrame: 30 days
measure: Stenosis rate
timeFrame: 30 days
measure: Post coagulation syndrome
timeFrame: 30 days
measure: Bowel obstruction rate
timeFrame: 30 days
measure: Rate of cases requiring transfusion related to post-EMR bleeding
timeFrame: 30 days
measure: Rate and duration of hospitalizations
timeFrame: 30 days
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital Européen Georges Pompidou, 20 Rue Leblanc
Study officials:
References: