An interventional study of Epinephrine 1:100,000 and Epinephrine 1:500,000 in Gastric Neoplasms and Gastric Dysplasia, sponsored by Unidade Local de Saúde do Alto Ave, EPE. Recruiting at 1 site in Portugal. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Unidade Local de Saúde do Alto Ave, EPE · Not applicable, Interventional, and Treatment
This prospective, randomized, single-center trial compares two epinephrine concentrations (1:100,000 and 1:500,000) in the submucosal injection solution used during gastric endoscopic submucosal dissection. The study evaluates whether the lower epinephrine concentration can maintain procedural efficiency while reducing epinephrine dose, without compromising hemostatic efficacy or safety. A total of 100 participants are planned.
This is a prospective, single-center, randomized trial evaluating two epinephrine concentrations used in the submucosal injection solution during gastric endoscopic submucosal dissection (ESD).
The study was initiated in July 2025 and remains ongoing. During ongoing recruitment, before completion of the planned enrollment of 100 participants, procedure time was defined as the primary outcome for a non-inferiority analysis comparing epinephrine 1:500,000 with 1:100,000. A non-inferiority margin of 15 minutes was prespecified. Non-inferiority will be concluded if the upper bound of the 95% confidence interval for the difference in procedure time (1:500,000 minus 1:100,000) is below 15 minutes.
3,399 studies on the registry are indexed under Stomach Neoplasms; 992 are open to participants now.
This study's planned enrollment of 100 is above the median of 66 across 2,499 interventional studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →Unidade Local de Saúde do Alto Ave, EPE is the lead sponsor of 4 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Submucosal injection solution containing epinephrine at a final concentration of 1:100,000 in Gelofusine with methylene blue, administered during gastric ESD.
Drug: Epinephrine 1:100,000
Submucosal injection solution containing epinephrine at a final concentration of 1:500,000 in Gelofusine with methylene blue, administered during gastric ESD.
Drug: Epinephrine 1:500,000
Epinephrine at a final concentration of 1:100,000, added to Gelofusine solution stained with methylene blue, administered by submucosal injection during gastric endoscopic submucosal dissection.
Also known as: Adrenaline 1:100,000
Epinephrine at a final concentration of 1:500,000, added to Gelofusine solution stained with methylene blue, administered by submucosal injection during gastric endoscopic submucosal dissection.
Also known as: Adrenaline 1:500,000
Gastric ESD procedure time
Total gastric endoscopic submucosal dissection procedure time, measured in minutes. The primary analysis will assess non-inferiority of epinephrine 1:500,000 compared with epinephrine 1:100,000. The non-inferiority margin is prespecified at 15 minutes. Non-inferiority will be concluded if the upper bound of the 95% confidence interval for the difference in procedure time (1:500,000 minus 1:100,000) is below 15 minutes.
Time frame: During the ESD procedure.
Any intraprocedural bleeding requiring hemostatic treatment
Proportion of participants experiencing intraprocedural bleeding requiring hemostatic treatment during gastric ESD, including knife coagulation, hemostatic forceps, clips, and/or hemostatic powder.
Time frame: During the gastric ESD procedure
Immediate post-procedural pain
Post-procedural pain assessed using a visual analogue scale (VAS) ranging from 0 to 10, where 0 represents no pain and 10 represents the worst imaginable pain.
Time frame: Immediately after the gastric ESD procedure
Hemoglobin decrease
Change in hemoglobin concentration from the pre-procedural value to the first post-procedural measurement, expressed in g/dL.
Time frame: Within 24 hours after gastric ESD
Delayed bleeding
Proportion of participants experiencing delayed bleeding after gastric ESD, defined by hematemesis or melena, a hemoglobin decrease of at least 2 g/dL, need for blood transfusion, or requirement for endoscopic, radiological, or surgical hemostatic treatment.
Time frame: Up to 30 days after gastric ESD
Injected solution volume
Total volume of submucosal injection solution administered during gastric ESD, expressed in milliliters.
Time frame: During the gastric ESD procedure
Intraprocedural cardiovascular adverse events
Proportion of participants experiencing cardiovascular adverse events during gastric ESD, including clinically relevant hypertension, hypotension, tachycardia, bradycardia, arrhythmia, or other cardiovascular events requiring medical intervention.
Time frame: During the gastric ESD procedure
Post-procedural cardiovascular adverse events
Proportion of participants experiencing cardiovascular adverse events after gastric ESD, including clinically relevant hypertension, hypotension, tachycardia, bradycardia, arrhythmia, or other cardiovascular events requiring medical intervention.
Time frame: Up to 30 days after gastric ESD
Intraprocedural bleeding requiring hemostatic modalities other than knife coagulation
Proportion of participants experiencing intraprocedural bleeding requiring additional hemostatic modalities other than knife coagulation, including hemostatic forceps, clips, and/or hemostatic powder.
Time frame: During the gastric ESD procedure
Total administered epinephrine dose
Total dose of epinephrine administered through the submucosal injection solution during gastric ESD, calculated from the total injected volume and the assigned epinephrine concentration, and expressed in milligrams.
Time frame: During the gastric ESD procedure
Plan to share: No — No formal plan has been established to share individual participant data with external researchers.
Started Jul 2025 (actual). Primary completion is estimated for Feb 2027, 18 months after the start.
Of 356 non-industry interventional studies with no phase under Stomach Neoplasms, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 66. This study's planned 18 months is below that.
Counting every sponsor, half of 367 studies reached it within 36 months; a quarter within 17 and three quarters within 63.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Unidade Local de Saúde do Alto Ave, EPE