RCT of Gastric ESD With or Without Epineprhine Added Solution

• Status: Recruiting
• Trial end date: 2022-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese University of Hong Kong
• Collaborators: Changi General Hospital; Fukuoka University; Ishikawa Prefectural Central Hospital; JCHO Osaka Hospital; Kosin University Gospel Hospital; Kyoto 2nd Red Cross Hospital; Machida General Hospital; Nara City Hospital; Osaka International Cancer Institute; Shizuoka Cancer Center; Wakayama Red Cross Hospital
• Treatments: Epinephrine; Epinephryl borate; Pharmaceutical Solutions; Racepinephrine

Criteria

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