The EPSILON study aims to comparatively evaluate the submucosal injection using ORISETM gel and glycerol during an ESD procedure in a specific population with superficial gastric and rectal (pre)neoplastic lesions.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* o Patients must have given written informed consent
* o Subjects with documented gastric or rectal lesions with indication of endoscopic removal by ESD, namely:
* Gastric focal lesion with suspicion of early gastric cancer (low or high grade dysplasia with features of early gastric cancer; adenocarcinoma with morphology of superficial lesion and work-up of superficial lesion)
* Rectal polyps (adenoma or superficial carcinoma) from 0 to 15 cm from the anal margin; with features being recognized indications of ESD: more than 20mm granular LST, more than 20mm non granular LST, more than 20mm villous or bulging polyps, Paris 0-IIa+IIc lesions, lesions with suspicious pattern (Kudo Vi / JNET 2B), lesions with anal canal involvement.
Exclusion Criteria:
* Subjects who meet any of the following exclusion criteria cannot be enrolled in the study:
* Gastric and rectal neuroendocrine tumour (NET) with indication of ESD will be excluded
* Gastric and rectal lesions with indication of ESD but strong fibrosis due to previous partial resection will be excluded
* Subject is currently enrolled in another confounding research
* Subjects with any other location of ESD (esophagus, duodenum and colon) will not be included.
What they're measuring
1
Increase the dissection speed of the ESD procedure