Clinical Trial

Intraoperative Margin Techniques for Esophagogastric Junction Adenocarcinoma: A Controlled Study

Not Yet Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated July 31, 2025 (before its estimated May 31, 2026 completion). Its status may not reflect the trial's current state.
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.
Trial Details
NCT Number NCT07095699
Lead Sponsor Fudan University
Conditions Adenocarcinoma of the Esophagogastric Junction
Enrollment 314 participants
Start Date 2025-08-15
Primary Completion 2026-05-31 (estimated)
Study Completion 2028-06-30 (estimated)
Updated on ClinicalTrials.gov 2025-07-31