Symptoms and General Pathology

All Conditions

Neoplasms

Digestive System Diseases

Hemorrhage

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Coagulants

All Drugs and Chemicals

Hemostatics

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)

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.

Endoscopic mucosal resection with nexpowder

Gabriel RAHMI, MD

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.

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

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

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

Number of patients with a satisfactory covering of the scar by the powder

Number of patients with a presence of air and fluid into the peritoneal cavity on the CT scanner

Number of patients with the impossibility to pass through the lumen with a standard colonoscope

Number of patients with a fever and abdominal pain without air or fluid into the peritoneal cavity on the CT scanner.

Number of patients with at least one symptomatic bowel obstruction.

Number of patients for whom at least one transfusion was ordered after the EMR

Number of hospitalizations and number of days of hospitalization per stay within 30 days after EMR

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Evaluation of Nexpowder Application to Prevent Delayed Bleeding After Colorectal Endoscopic Mucosal Resection	NCT05247515	Colorectal Canc...	Endoscopic muco...	18 Years - 90 Years	French Society of Digestive Endoscopy
Evaluation of Nexpowder Application to Prevent Delayed Bleeding After Colorectal Endoscopic Mucosal Resection	NCT05247515	Colorectal Canc...	Endoscopic muco...	18 Years - 90 Years	French Society of Digestive Endoscopy

Spots Global Cancer Trial Database for hemostatic powder