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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

Gabriel RAHMI

Principal Investagator, Medical Doctor

Recurrence

Cicatrix

Polyps

Disease Attributes

Assessment of endoscopic images prior to a learning tool about scars and recurrence

Assessment of endoscopic images after a learning tool about scars and recurrence

Video based learning tool about detection of endoscopic resection scars and recurrence.

Learning tool

David J trate, PhD

Sander Smeets, MD

David J Tate, PhD

Colorectal cancer is prevented by colonoscopy and polypectomy. Failure to recognize the endoscopic resection scar after Endoscopic Mucosal Resection (EMR) risks unrecognized recurrent or residual adenoma (RRA), which may propagate into post-colonoscopy colorectal cancer. Expert series suggest scar recognition and interrogation is well performed with a high negative predictive value of endoscopic imaging vs histopathology. In this study the authors will investigate the performance of endoscopic imaging in detecting RRA at an endoscopic resection scar amongst general endoscopist and the impact of a learning intervention on recognition of RRA.

Colorectal cancer is prevented by polypectomy. Failure to recognize the scar after EMR risks unrecognized recurrent or residual adenoma (RRA), which may propagate into post-colonoscopy colorectal cancer. Expert series suggest scar recognition and interrogation is well performed with a high negative predictive value of endoscopic imaging vs histopathology.

In this study the authors will investigate the performance of endoscopic imaging in detecting RRA at an endoscopic resection scar amongst general endoscopist and the impact of a learning intervention on recognition of RRA.

A survey containing 15 High Definition - White Light (HD-WL) and Narrow Band Imaging (NBI) images, a learning intervention on detection of RRA (LT), then another set of 15 images was circulated to a mailing list of the GIEQs (Gastrointestinal Endoscopy Quality and Safety) foundation. Each image contained the same questions: Is this a resection scar? Is there RRA? What is your level of confidence? Information on the participant was obtained: number of EMRs performed, grade (consultant vs trainee) and years of experience. Comparisons were made to expert opinion derived at a consensus meeting of the senior authors regarding the appearances of the scars using the approach set out in Desomer et al. 2017.

Detection of Endoscopic Resection Scars and Delineation of Recurrence is Trainable

Detection of Endoscopic Resection Scars and Delineation of Recurrence Amongst Non-experts is Less Accurate Than Experts But Trainable in a Short Learning Intervention

Individual participant data will not be made available to other researchers

Performance of detecting a recurrence at an endoscopic resection scar.

Performance of a learning tool in improving detection of recurrence at an endoscopic resection scar

Difference in performance of detecting a recurrence at an endoscopic resection scar between endoscopists with different experience level

Performance of a learning tool in improving detection of recurrence at an endoscopic resection scar compared between endoscopists with different experience level

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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
Detection of Endoscopic Resection Scars and Delineation of Recurrence is Trainable	NCT06193356	Colorectal Poly... Colorectal Canc...	Learning tool	18 Years -	University Hospital, Ghent

Spots Global Cancer Trial Database for colorectal polypectomy