Clinical trial · Interventional
RCT of Gastric ESD With or Without Epineprhine Added Solution
Multicenter Randomized Controlled Trial of Gastric Endoscopic Submucosal Dissection With or Without Epineprhine Added Solution
NCT04032119CI-TRIAL-00089306completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Early Gastric Cancer | Early Gastric Carcinoma | ALIAS | 0.90 |
| Gastric Neoplasm | Gastric Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endoscopic submucosal dissection | Procedure | — | UNRESOLVED |
| Epinephrine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Epinephrine
- description
- 0.2ml 1:10000 epinephrine diluted into each 20ml of the original solution for submucosal injection
- interventionNames
- Procedure: Endoscopic submucosal dissection
- Drug: Epinephrine
- type
- ACTIVE_COMPARATOR
- label
- Non-epinephrine
- description
- No epinephrine would be added into the solution
- interventionNames
- Procedure: Endoscopic submucosal dissection
Primary outcomes (1)
- measure
- Overall procedural time
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDYip HC, Uedo N, Iwagami H, Waki K, Ohtsu K, Miyaoka M, Yao K, Akamatsu T, Konishi T, Nakano S, Nakanishi H, Doyama H, Machida H, Jung K, Chiu P, Iwasaki T, Uchita K, Kawamura T, Takizawa K, Kitamura Y, Li JW, Ang TL, Shimokawa T, Zhu Z, Yung MY. The use of diluted epinephrine during gastric endoscopic submucosal dissection: an international randomized controlled trial. Gastrointest Endosc. 2026 Sep;104(3):387-395.e1. doi: 10.1016/j.gie.2026.01.031. Epub 2026 Jan 29. PMID 41620139