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%.

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).

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.