Clinical trial NCT06096948: Nexpowder to Prevent Delayed Bleeding After Endoscopic Resection
Official title: Safety and Efficacy of a New Hemostatic System to Prevent Delayed Bleeding After Endoscopic Resection in a Selected High-risk Population
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastro Intestinal Bleeding
Polyps
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
First posted: 2023-10-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Safety and effectiveness of a new hemostatic system to prevent delayed bleeding after endoscopic resection in a selected high-risk population (NEXPOWDER- ENDOHS).

Indication:

Patients with indication of endoscopy resection by endoscopic mucal resection (EMR) or endoscopic submucosal dissection (ESD) with high risk of delayed bleeding (≥5%).

Hypotheses:

The use of NexpowderTM after upper and lower gastrointestinal ESD or EMR of ≥20mm in high-risk population will prevent and decrease delayed bleeding to less than 5%.

Detailed description: Hypotheses:

The use of NexpowderTM after upper and lower gastrointestinal ESD or EMR of ≥20mm in high-risk population will prevent and decrease delayed bleeding to less than 5%.

Study design:

This is an investigator-initiated, multicentric, international, open-label, non-controlled, prospective study:

* All subjects with indications undergo screening and baseline visit,
* Informed consent is obtained when scheduling the ESD or EMR procedure,
* ESD or EMR is performed, at the end of resection, NexpowderTM is applied on the resected field,
* A follow up visit is scheduled at 4 weeks.

Endpoints:

* Primary:
* Assess the delayed bleeding rate after ESD or EMR of ≥20mm in a selected high-risk population when using NexpowderTM at the end of the procedure.

This hypothesis is that the use of NexpowderTM will reduce the rate of DB from 16% (reported rate in the literature) to less than 5% (excepted observed rate during the study).

* Secondary:
* Safety of NexpowderTM endoscopic hemostasis system,
* Procedure duration and NexpowderTM spaying duration,
* Length of stay in hospital,
* Post intervention pain,
* Adverse events related to the use of NexpowderTM:
* Per procedural
* Early (up to controlled endoscopy or at 24hours post procedure)
* Late (up to 4 weeks follow-up).

Eligibility criteria: Inclusion Criteria:

* Age: ≥18 year of age at the time of informed consent,
* Patients must have given written informed consent,
* Subjects with documented lesions with indication of upper or lower endoscopic removal by ESD or EMR with high risk of delayed bleeding (+/-16%), namely:
* All patients under anticoagulation (vitamin K antagonist, direct anticoagulant, non-fractionated heparin or low molecular weight heparin) or anti-aggregating (P2Y12 receptor antagonists),
* Patients without anticoagulation or anti-aggregating with indication of duodenal EMR or ESD (if duodenal cold snare EMR: only under anticoagulant or P2Y12 receptor antagonist),
* Resection field of ESD or EMR is ≥ 20mm (same size restriction in case of endoscopic papillectomy).

Exclusion Criteria:

* Resection bed \<20mm,
* Subject currently enrolled in another interventional confounding research (no contra-indication for image or blood collection in another protocol),
* Incapacitated subjects, pregnant or lactating women.

Primary outcomes:
measure: Safety in terms of Adverse Events (AE related to Nexpowder)
timeFrame: 1 month
measure: Efficacy of Nexpowder in changing the delayed bleeding rate
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: AZ Maria Middelares
state: Oost-Vlaanderen
city: Leuven
country: Belgium
facility: UZ Gasthuisberg (KUL)
state: Vlaams Brabant
city: Brugge
country: Belgium
facility: AZ Sint-Jan Brugge-Oostende
state: West-Vlaanderen
city: Roeselare
country: Belgium
facility: AZ Delta Campus Rumbeke
state: West-Vlaanderen
city: Brussels
country: Belgium
facility: HUB - Hôpital Erasme, Service de Gastro-Entérologie (ULB)
city: Brussels
country: Belgium
facility: Cliniques universitaires Saint-Luc (UCL)
city: Brussel
country: Belgium
facility: CHU Saint-Pierre
city: Gent
country: Belgium
facility: UZ Gent
city: Liège
country: Belgium
facility: Groupe Santé CHC - Clinique du MontLégia
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC - Location VUMC
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC - Location AMC
city: Utrecht
country: Netherlands
facility: UMC Utrecht
Study officials:
References: