Adenocarcinoma of the Esophagogastric JunctionNCT07095699
Intraoperative Margin Techniques for Esophagogastric Junction Adenocarcinoma: A Controlled Study
A study testing EndoSCell System in people with Adenocarcinoma of the Esophagogastric Junction, run by Fudan University.
Trial summary
The goal of this clinical trial is to learn if the EndoScell Scanner (ES) imaging system can accurately assess tumor-free surgical margins during surgery for adenocarcinoma of the esophagogastric junction (AEG), compared with standard frozen-section pathology. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Adenocarcinoma of the Esophagogastric Junction
- What is being tested?
- EndoSCell System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 314 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2025to 30 Jun 2028
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients clinically diagnosed with adenocarcinoma of the esophagogastric junction (AEG):
- Including patients with Siewert type II and III AEG; Including patients in cT1 stage (recommended esophageal resection margin distance ≥1.5cm) and cT2 and above (recommended esophageal resection margin distance ≥3cm);
- Plan to receive surgical resection of AEG;
- Patients voluntarily participated in this study and signed the informed consent form;
Who cannot join
- Patients who are allergic to methylene blue and fluorescein sodium;
- Patients with severe cardiovascular or circulatory system diseases and cannot tolerate surgery;
- Participated in other clinical trials of research drugs or devices in the past month;
- Unable to understand the test requirements or unable to complete the study follow-up plan;
- Pregnant and lactating women;
- Patients who are unable to complete follow-up due to mental illness, cognitive or emotional disorders;
- Subjects who are considered by the researchers to be unsuitable for participating in the study.
About this study
Official title: An Exploratory, Parallel Controlled Study to Explore the Effectiveness of Intraoperative Margin Exploration Techniques for Adenocarcinoma of the Esophagogastric Junction
The goal of this clinical trial is to learn if the EndoScell Scanner (ES) imaging system can accurately assess tumor-free surgical margins during surgery for adenocarcinoma of the esophagogastric junction (AEG), compared with standard frozen-section pathology.
The main questions it aims to answer are:
Read more
- Is ES non-inferior to intraoperative frozen-section pathology in identifying positive or negative tumor margins?
- Does ES shorten the time needed for margin assessment and reduce the number of additional tissue resections required?
Researchers will compare an ES-assisted surgical arm with a conventional frozen-section arm to see if ES improves margin accuracy, shortens operative time, and increases the rate of complete (R0) tumor removal.
Participants will
- undergo standard AEG resection with randomized assignment to either ES or frozen-section margin checks;
- allow collection of margin tissue samples for ES, frozen-section, and final paraffin pathology;
- attend routine follow-up visits for up to 2 years to monitor for local recurrence.
- Being tested
- EndoSCell System
- Keywords
- AEG resection, fluorescent, microscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndoSCell SystemDevice
EndoSCell Scaner (ES) is a new type of intraoperative cell-level fluorescence-guided imaging technology that can be used for direct and rapid intraoperative tissue cell interpretation. This technology uses a handheld cell microscope system to magnify local tissue by about 1280 times, and can perform rapid real-time scanning and imaging of in vivo or excised ex vivo tissue.
| Study group | Role | What they receive |
|---|---|---|
| ES group | Experimental | ES-assisted surgery Receives: Device: EndoSCell System |
| FS Group | No intervention | Frozen Section without ES scanning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy
Using paraffin pathology as the gold standard, the accuracy of ES system and frozen pathology for AEG resection margin was evaluated: Accuracy Rate = true positive + true negative/total number of samples.
Measured: intraoperative
Secondary outcomes (8)
Evaluation of R0 resection rate
The proportion of surgical resection specimens without residual tumor at the resection margin using paraffin pathology as the gold standard.
Measured: 7days after the surgery
Positive margin rate
Using paraffin pathology as the gold standard, the proportion of ES interpretation as positive but frozen pathology showing negative
Measured: 7days after the surgery
Evaluation of the actual resection margin distance during ES-assisted AEG
Evaluation of the actual resection margin distance during ES-assisted AEG
Measured: 7days after the surgery
Evaluate the sensitivity, specificity, PPV, and NPV of ES technology
Evaluate the sensitivity, specificity, PPV, and NPV of ES technology
Measured: 7days after the surgery
Evaluation of the consistency between ES technique and frozen pathology
Evaluation of the consistency between ES technique and frozen pathology
Measured: 7days after the surgery
Postoperative recurrence: evaluate the anastomotic recurrence rate at 6, 12 months, and 2 years after surgery
Postoperative recurrence: evaluate the anastomotic recurrence rate at 6, 12 months, and 2 years after surgery
Measured: 6, 12 months, and 2 years after surgery
Evaluation of the time efficiency of ES and frozen pathology
ES real-time interpretation time vs frozen pathology result time
Measured: 7days after the surgery
Evaluate the number of timely adjustments to the resection range due to the interpretation of ES technology;
Evaluate the number of timely adjustments to the resection range due to the interpretation of ES technology;
Measured: 7days after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start15 Aug 2025 (estimated)
- Primary completion31 May 2026 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarcinoma of the Esophagogastric JunctionStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 314 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fenglin Liu, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07095699
- Sponsor's protocol ID
- 20250308
- Status last verified
- Jun 2025
- First submitted
- 23 Jul 2025
- Last updated
- 31 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory, Parallel Controlled Study to Explore the Effectiveness of Intraoperative Margin Exploration Techniques for Adenocarcinoma of the Esophagogastric Junction
- ClinicalTrials.gov ID
- NCT07095699
- Acronym / sponsor ID
- 20250308
- Keywords
- AEG resection, fluorescent, microscope
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 314 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 15 Aug 2025 (estimated)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 31 Jul 2025 (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.
The goal of this clinical trial is to learn if the EndoScell Scanner (ES) imaging system can accurately assess tumor-free surgical margins during surgery for adenocarcinoma of the esophagogastric junction (AEG), compared with standard frozen-section pathology.
The main questions it aims to answer are:
- Is ES non-inferior to intraoperative frozen-section pathology in identifying positive or negative tumor margins?
- Does ES shorten the time needed for margin assessment and reduce the number of additional tissue resections required?
Researchers will compare an ES-assisted surgical arm with a conventional frozen-section arm to see if ES improves margin accuracy, shortens operative time, and increases the rate of complete (R0) tumor removal.
Participants will
- undergo standard AEG resection with randomized assignment to either ES or frozen-section margin checks;
- allow collection of margin tissue samples for ES, frozen-section, and final paraffin pathology;
- attend routine follow-up visits for up to 2 years to monitor for local recurrence.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ES group | Experimental | Device: EndoSCell SystemES-assisted surgery |
| FS Group | No intervention | –Frozen Section without ES scanning |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients clinically diagnosed with adenocarcinoma of the esophagogastric junction (AEG):
- Including patients with Siewert type II and III AEG; Including patients in cT1 stage (recommended esophageal resection margin distance ≥1.5cm) and cT2 and above (recommended esophageal resection margin distance ≥3cm);
- Plan to receive surgical resection of AEG;
- Patients voluntarily participated in this study and signed the informed consent form;
Key exclusion criteria (7 listed)
- Patients who are allergic to methylene blue and fluorescein sodium;
- Patients with severe cardiovascular or circulatory system diseases and cannot tolerate surgery;
- Participated in other clinical trials of research drugs or devices in the past month;
- Unable to understand the test requirements or unable to complete the study follow-up plan;
- Pregnant and lactating women;
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 |
|---|---|---|
| EndoSCell SystemEndoSCell Scaner (ES) is a new type of intraoperative cell-level fluorescence-guided imaging technology that can be used for direct and rapid intraoperative tissue cell interpretation. This technology uses a handheld cell microscope system to magnify local tissue by about 1280 times, and can perform rapid real-time scanning and imaging of in vivo or excised ex vivo tissue. | Device | ES group |
Primary outcome
Accuracy
Time frame: intraoperative
Using paraffin pathology as the gold standard, the accuracy of ES system and frozen pathology for AEG resection margin was evaluated: Accuracy Rate = true positive + true negative/total number of samples.
8 secondary outcomes
Evaluation of R0 resection rate
Time frame: 7days after the surgery
Positive margin rate
Time frame: 7days after the surgery
Evaluation of the actual resection margin distance during ES-assisted AEG
Time frame: 7days after the surgery
Evaluate the sensitivity, specificity, PPV, and NPV of ES technology
Time frame: 7days after the surgery
Evaluation of the consistency between ES technique and frozen pathology
Time frame: 7days after the surgery
Postoperative recurrence: evaluate the anastomotic recurrence rate at 6, 12 months, and 2 years after surgery
Time frame: 6, 12 months, and 2 years after surgery
Evaluation of the time efficiency of ES and frozen pathology
Time frame: 7days after the surgery
Evaluate the number of timely adjustments to the resection range due to the interpretation of ES technology;
Time frame: 7days after the surgery
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 31 Jul 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing EndoSCell System in people with Adenocarcinoma of the Esophagogastric Junction, run by Fudan University.
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 4 inclusion and 7 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: opening soon, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy (time frame: intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jul 2025.