Status:
COMPLETED
RCT of Gastric ESD With or Without Epineprhine Added Solution
Lead Sponsor:
Chinese University of Hong Kong
Collaborating Sponsors:
Osaka International Cancer Institute
Fukuoka University
Conditions:
Gastric Neoplasm
Early Gastric Cancer
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief 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 injecti...
Detailed Description
Endoscopic submucosal dissection (ESD) is an endoscopic technique aiming to achieve en-bloc resection of mucosal neoplastic lesion in the gastrointestinal tract. It is now considered as the standard o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2023
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT04032119
Start Date
January 10 2020
End Date
January 31 2023
Last Update
May 4 2025
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
The Chinese University of Hong Kong
Hong Kong, Hong Kong
2
Ishikawa Prefecture Central Hospital
Ishikawa, Japan
3
Kyoto 2nd Red Cross Hospital
Kyoto, Japan
4
Osaka International Cancer Institute
Osaka, Japan