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Brief Title: EndoscoPic Submucosal dIssection Using geL Versus glycerOl for Submucosal iNjection
Official Title: EndoscoPic Submucosal dIssection Using geL Versus glycerOl for Submucosal iNjection: a Randomized Controlled Multicentric Trial (EPSILON)
Study ID: NCT04977401
Brief Summary: 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.
Detailed Description: Traditionally, ESD requires the injection of some colloidal solution (glycerol, geloplasma, hydroxyethylstrach, etc.) in the submucosal layer in order to obtain long lifting effect and thus allowing the endoscopist to dissect under the lesion. Alternatives to colloid-solution assisted ESD have also been developped: pocket creation method and saline-immersion ESD. Recently, other colloidal solutions have arrived on the market, such as gel (ORISETM gel) in order to improve the lifting during ESD.Our preliminary experience using ORISETM gel as a lifting solution for ESD was unexpectedly favourable with few per-procedural bleeding, quick time and facility. As the spread of ESD is closely associated to its easiness, procedure duration (itself associated to number of procedural bleedings and instruments change through the operating channel) and safety, we sought to study comparatively two submucosal solutions when conducting ESD in a specific population presenting gastric or rectal superficial lesions.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Erasme Hospital, Université Libre de Bruxelles. (ULB), Brussels, , Belgium
Evangelisches Krankenhaus, Düsseldorf, , Germany
Keio University Hospital, Tokyo, , Japan
Name: Arnaud Lemmers, MD,PhD
Affiliation: Erasme Hospital, Université Libre de Bruxelles. (ULB), Brussels, Belgium
Role: PRINCIPAL_INVESTIGATOR