RCT of Gastric ESD With or Without Epineprhine Added Solution (NCT04032119) | Clinical Trial Compass
CompletedPhase 3
RCT of Gastric ESD With or Without Epineprhine Added Solution
Hong Kong, Japan800 participantsStarted 2020-01-10
Plain-language summary
This is an international multi-center randomised controlled study comparing outcomes of gastric endoscopic submucosal dissection (ESD) with or without addition of epinephrine in the submucosal injection solution.
Who can participate
Age range20 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:
* Selection criteria: Presence of intramucosal neoplastic lesions in the stomach planning for endoscopic submucosal dissection (Vienna Classification Category 3 and 4 lesion)
* Target subjects receiving sufficient briefing from the attending physician regarding the content of this study and providing informed consent for participation
Exclusion Criteria:
* Recurrent / remnant lesion after previous endoscopic resection
* Lesions arising from surgical anastomotic site, such as gastrojejunostomy / gastroduodenostomy.
* Marked electrolyte abnormalities
* Hemostatic or coagulative abnormalities
* Patient on anti-coagulant agents, including warfarin and other direct oral anti-coagulants (those on antiplatelet can be included)
* Failure of vital organ (heart, lungs, liver, or kidneys) function
* Allergic to components of injection solutions: Epinephrine, hyaluronic acid etc
* Other cases deemed by the examining physician as unsuitable for safe treatment