Intraoperative Margin Techniques for Esophagogastric Junction Adenocarcinoma: A Controlled Study

Fudan University

Status

Not yet enrolling

Conditions

Adenocarcinoma of the Esophagogastric Junction

Treatments

Device: EndoSCell System

Study type

Interventional

Funder types

Other

Identifiers

NCT07095699

20250308

Details and patient eligibility

About

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.

Enrollment

314 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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;

Exclusion criteria

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.