Overview
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%.
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
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.