Intraoperative Margin Techniques for Esophagogastric Junction Adenocarcinoma: A Controlled Study

NCT07095699 | Not Yet Recruiting

• 1 other identifier: 20250308
• Study Type: interventional
• Target: 314
• Locations: 0 countries
• Sites: N/A

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

Keywords

AEG resection; fluorescent; microscope

Outcome Measures

Primary Outcomes (1)

• 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.

  intraoperative

Secondary Outcomes (8)

• Evaluation of R0 resection rate

  7days after the surgery

• Positive margin rate

  7days after the surgery

• Evaluation of the actual resection margin distance during ES-assisted AEG

  7days after the surgery

• Evaluate the sensitivity, specificity, PPV, and NPV of ES technology

  7days after the surgery

• Evaluation of the consistency between ES technique and frozen pathology

  7days after the surgery

Other Outcomes (1)

• Accuracy of ES interpretation in different Siewert classifications (type II vs. type III)

  7days after the surgery

Study Arms (2)

ES group

EXPERIMENTAL

ES-assisted surgery

Device: EndoSCell System

FS Group

NO INTERVENTION

Frozen Section without ES scanning

Interventions

EndoSCell System 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.

ES group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: senior doctor

Study Record Dates

• First Submitted: July 23, 2025
• First Posted: July 31, 2025
• Study Start: August 15, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): June 30, 2028
• Last Updated: July 31, 2025

Record last verified: 2025-06