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Intraoperative Margin Techniques for Esophagogastric Junction Adenocarcinoma: A Controlled Study

NCT07095699 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 314

Last updated 2025-07-31

No results posted yet for this study

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.

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.

Conditions

  • Adenocarcinoma of the Esophagogastric Junction

Interventions

DEVICE

EndoSCell System

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.

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-15
Primary Completion
2026-05-31
Completion
2028-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07095699 on ClinicalTrials.gov