Intraoperative Margin Techniques for Esophagogastric Junction Adenocarcinoma: A Controlled Study

NCT ID: NCT07095699

Last Updated: 2025-07-31

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 314 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-15
• Study Completion Date: 2028-06-30

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

ES group

ES-assisted surgery

Group Type: EXPERIMENTAL

EndoSCell System

Intervention Type: DEVICE

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.

FS Group

Frozen Section without ES scanning

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Fenglin Liu

senior doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

20250308

Identifier Type: -

Identifier Source: org_study_id