Intraoperative Margin Techniques for Esophagogastric Junction Adenocarcinoma: A Controlled Study

ConditionAdenocarcinoma of the Esophagogastric Junction

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-65

SponsorFudan University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Plan to receive surgical resection of AEG;

Patients voluntarily participated in this study and signed the informed consent form;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

314 Participants

are divided into 2 treatment groups

Group A: ES groupExperimental treatment 1 intervention

Group B: FS GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

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.

Time frame

intraoperative

Secondary outcomes

Evaluation of R0 resection rate

The proportion of surgical resection specimens without residual tumor at the resection margin using paraffin pathology as the gold standard.

Time frame

7days after the surgery

Positive margin rate

Using paraffin pathology as the gold standard, the proportion of ES interpretation as positive but frozen pathology showing negative

Time frame

7days after the surgery

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

Time frame

7days after the surgery

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

Time frame

7days after the surgery

Other outcomes

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

Time frame

7days after the surgery

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fudan University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: