Gastric NeoplasmsEPI-DILUTENCT07920068
Epinephrine 1:100,000 Versus 1:500,000 During Gastric Endoscopic Submucosal Dissection
A study testing Epinephrine 1:100,000 and Epinephrine 1:500,000 in people with Gastric Neoplasms and Gastric Dysplasia, run by Unidade Local de Saúde do Alto Ave, EPE at 1 site in Portugal.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Neoplasms, Gastric Dysplasia
- What is being tested?
- Epinephrine 1:100,000 and Epinephrine 1:500,000
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePortugal
- Study dates
- 30 Jul 2025to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site, 1 recruiting
- Recruiting
Unidade Local de Saúde do Alto Ave
Guimarães, Braga District, 4835-044
Mariana Souto, MD, +351914114648, mariana.souto9@gmail.com
mariana.souto9@gmail.com
About this study
Official title: Optimal Epinephrine Concentration in Gastric Endoscopic Submucosal Dissection: A Prospective Randomized Trial
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.
Read the detailed description
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.
- Conditions
- Gastric Neoplasms, Gastric Dysplasia
- Being tested
- Epinephrine 1:100,000, Epinephrine 1:500,000
- Keywords
- Gastric endoscopic submucosal dissection, Epinephrine, Adrenaline, Gastric neoplasia, Gastric dysplasia
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epinephrine 1:100,000Drug
Also called Adrenaline 1:100,000
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.
Epinephrine 1:500,000Drug
Also called Adrenaline 1:500,000
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - Active Comparator: Epinephrine 1:100,000 | Active comparator | Submucosal injection solution containing epinephrine at a final concentration of 1:100,000 in Gelofusine with methylene blue, administered during gastric ESD. Receives: Drug: Epinephrine 1:100,000 |
| Arm 2 - Experimental: Epinephrine 1:500,000 | Experimental | Submucosal injection solution containing epinephrine at a final concentration of 1:500,000 in Gelofusine with methylene blue, administered during gastric ESD. Receives: Drug: Epinephrine 1:500,000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the ESD procedure.
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 30 days after gastric ESD
Injected solution volume
Total volume of submucosal injection solution administered during gastric ESD, expressed in milliliters.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: During the gastric ESD procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start30 Jul 2025
- Primary completion27 Feb 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unidade Local de Saúde do Alto Ave, EPE
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariana Marques Souto, Unidade Local de Saúde do Alto Ave, EPE
- Investigators
- Mariana Souto, MD, Principal investigator, Unidade Local de Saúde do Alto Ave
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07920068
- Sponsor's protocol ID
- CIC20260089
- Acronym
- EPI-DILUTE
- Status last verified
- Oct 2026
- First submitted
- 31 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No formal plan has been established to share individual participant data with external researchers.
Publications
Inoue S, Uedo N, Tabuchi T, Nakagawa K, Ohmori M, Iwagami H, Matsuno K, Iwatsubo T, Nakahira H, Matsuura N, Shichijo S, Maekawa A, Kanesaka T, Takeuchi Y, Higashino K, Ishihara R. Usefulness of epinephrine-added injection solution to reduce procedure time for gastric endoscopic submucosal dissection. Endosc Int Open. 2020 Aug;8(8):E1044-E1051. doi: 10.1055/a-1192-4202. Epub 2020 Jul 21.
PubMed 32743058
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Epinephrine Concentration in Gastric Endoscopic Submucosal Dissection: A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT07920068
- Acronym / sponsor ID
- EPI-DILUTE / CIC20260089
- Conditions
- Gastric Neoplasms, Gastric Dysplasia
- Keywords
- Gastric endoscopic submucosal dissection, Epinephrine, Adrenaline, Gastric neoplasia, Gastric dysplasia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Unidade Local de Saúde do Alto Ave, EPEUniversity, hospital or other
- Study start
- 30 Jul 2025 (actual)
- Primary completion
- 27 Feb 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 5 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - Active Comparator: Epinephrine 1:100,000 | Active comparator | Drug: Epinephrine 1:100,000Submucosal injection solution containing epinephrine at a final concentration of 1:100,000 in Gelofusine with methylene blue, administered during gastric ESD. |
| Arm 2 - Experimental: Epinephrine 1:500,000 | Experimental | Drug: Epinephrine 1:500,000Submucosal injection solution containing epinephrine at a final concentration of 1:500,000 in Gelofusine with methylene blue, administered during gastric ESD. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epinephrine 1:100,000Also: Adrenaline 1:100,000Epinephrine 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. | Drug | Arm 1 - Active Comparator: Epinephrine 1:100,000 |
| Epinephrine 1:500,000Also: Adrenaline 1:500,000Epinephrine 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. | Drug | Arm 2 - Experimental: Epinephrine 1:500,000 |
Primary outcome
Gastric ESD procedure time
Time frame: During the ESD procedure.
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.
9 secondary outcomes
Any intraprocedural bleeding requiring hemostatic treatment
Time frame: During the gastric ESD procedure
Immediate post-procedural pain
Time frame: Immediately after the gastric ESD procedure
Hemoglobin decrease
Time frame: Within 24 hours after gastric ESD
Delayed bleeding
Time frame: Up to 30 days after gastric ESD
Injected solution volume
Time frame: During the gastric ESD procedure
Intraprocedural cardiovascular adverse events
Time frame: During the gastric ESD procedure
Post-procedural cardiovascular adverse events
Time frame: Up to 30 days after gastric ESD
Intraprocedural bleeding requiring hemostatic modalities other than knife coagulation
Time frame: During the gastric ESD procedure
Total administered epinephrine dose
Time frame: During the gastric ESD procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Background: PubMed 32743058Inoue S, Uedo N, Tabuchi T, Nakagawa K, Ohmori M, Iwagami H, Matsuno K, Iwatsubo T, Nakahira H, Matsuura N, Shichijo S, Maekawa A, Kanesaka T, Takeuchi Y, Higashino K, Ishihara R. Usefulness of epinephrine-added injection solution to reduce procedure time for gastric endoscopic submucosal dissection. Endosc Int Open. 2020 Aug;8(8):E1044-E1051. doi: 10.1055/a-1192-4202. Epub 2020 Jul 21.
- Individual participant dataSharing planned: No. No formal plan has been established to share individual participant data with external researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mariana Souto, MD principal investigator
Unidade Local de Saúde do Alto Ave
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epinephrine 1:100,000 and Epinephrine 1:500,000 in people with Gastric Neoplasms and Gastric Dysplasia, run by Unidade Local de Saúde do Alto Ave, EPE at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mariana Souto, MD (+351914114648, mariana.souto9@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastric ESD procedure time (time frame: During the ESD procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07920068, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.