Epinephrine concentrations during gastric submucosal dissection in adults with gastric neoplasia
Official title: Optimal Epinephrine Concentration in Gastric Endoscopic Submucosal Dissection: A Prospective Randomized Trial
Run by Unidade Local de Saúde do Alto Ave, EPE · NCT07920068 · Data updated 2026-11-12
This trial tests whether a lower dose of epinephrine (1:100,000) during gastric ESD works as well as a higher dose (1:500,000) to keep procedures efficient and safe in adults with gastric dysplasia or neoplasia.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Unidade Local de Saúde do Alto Ave, EPE Academic / other |
| Locations | 1 site (Guimarães, Braga District) |
| Status | Recruiting |
| Started | July 30, 2025 |
| Main results expected | February 27, 2027 |
| Study ends | March 31, 2027 |
| Registry record updated | November 5, 2026 |
| Trial ID | NCT07920068 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 years or older scheduled for gastric ESD for dysplasia or neoplasia who can provide informed consent.
✕Probably not a fit
Patients with contraindications to components of the injection solution or who cannot safely participate may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective, single-center, randomized study compares two concentrations of epinephrine in the submucosal injection solution used during gastric endoscopic submucosal dissection for dysplastic or neoplastic gastric lesions. The primary aim is to see if the lower concentration can maintain procedure time within a non-inferiority margin while preserving hemostatic efficacy and safety. A total of 100 participants are planned, with non-inferiority analyzed using the difference in procedure time between groups. Enrollment started in July 2025 and is ongoing. The study is conducted at Unidade Local de Saúde do Alto Ave in Guimarães, Portugal.
Why it matters
Potential benefit: If successful, the lower epinephrine dose could reduce drug exposure without sacrificing efficiency or safety during gastric ESD.
How similar studies have gone: Non-inferiority trials of epinephrine concentrations in endoscopic procedures have shown variable results; this study adds data specific to gastric ESD.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 years or older. * Patients scheduled to undergo gastric endoscopic submucosal dissection (ESD) for a dysplastic or neoplastic gastric lesion. * Ability to provide written informed consent for participation in the study. Exclusion Criteria: * Refusal or inability to provide informed consent. * Contraindication to any component of the submucosal injection solution used in the study. * Any clinical condition considered by the investigator to preclude safe participation in the study.
Where it's running
-
Unidade Local de Saúde do Alto Ave
Guimarães, Braga District, Portugal Recruiting
Study contacts
- Principal investigator: Mariana Souto, MD — Unidade Local de Saúde do Alto Ave
- Study coordinator: Mariana Souto, MD
- Email: mariana.souto9@gmail.com
- Phone: +351914114648
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.