Epinephrine 1:100,000 Versus 1:500,000 During Gastric Endoscopic Submucosal Dissection
NCT07920068, Not applicable, Recruiting, Unidade Local de Saúde do Alto Ave, EPE
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Epinephrine 1:100,000 Versus 1:500,000 During Gastric Endoscopic Submucosal Dissection | ClinicalTrials.gov |
| NCT number | NCT07920068 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 100 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Unidade Local de Saúde do Alto Ave, EPE | ClinicalTrials.gov |
| Conditions | Gastric Neoplasms, Gastric Dysplasia | ClinicalTrials.gov |
| Interventions | Epinephrine 1:100,000, Epinephrine 1:500,000 | ClinicalTrials.gov |
| First posted | 2026-11-05 | ClinicalTrials.gov |
| Last updated | 2026-11-05 | ClinicalTrials.gov |
Registered outcomes 10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Gastric ESD procedure time | 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. | ClinicalTrials.gov |
| Secondary | Any intraprocedural bleeding requiring hemostatic treatment | During the gastric ESD procedure | Proportion of participants experiencing intraprocedural bleeding requiring hemostatic treatment during gastric ESD, including knife coagulation, hemostatic forceps, clips, and/or hemostatic powder. | ClinicalTrials.gov |
| Secondary | Immediate post-procedural pain | Immediately after the gastric ESD procedure | 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. | ClinicalTrials.gov |
| Secondary | Hemoglobin decrease | Within 24 hours after gastric ESD | Change in hemoglobin concentration from the pre-procedural value to the first post-procedural measurement, expressed in g/dL. | ClinicalTrials.gov |
| Secondary | Delayed bleeding | Up to 30 days after gastric ESD | 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. | ClinicalTrials.gov |
| Secondary | Injected solution volume | During the gastric ESD procedure | Total volume of submucosal injection solution administered during gastric ESD, expressed in milliliters. | ClinicalTrials.gov |
| Secondary | Intraprocedural cardiovascular adverse events | During the gastric ESD procedure | 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. | ClinicalTrials.gov |
| Secondary | Post-procedural cardiovascular adverse events | Up to 30 days after gastric ESD | 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. | ClinicalTrials.gov |
| Secondary | Intraprocedural bleeding requiring hemostatic modalities other than knife coagulation | During the gastric ESD procedure | Proportion of participants experiencing intraprocedural bleeding requiring additional hemostatic modalities other than knife coagulation, including hemostatic forceps, clips, and/or hemostatic powder. | ClinicalTrials.gov |
| Secondary | Total administered epinephrine dose | During the gastric ESD procedure | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 32743058 | BACKGROUND | PubMed |
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)