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NCT Number: NCT07095699

Intraoperative Margin Techniques for Esophagogastric Junction Adenocarcinoma: A Controlled Study

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.

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Key information

Conditions

Adenocarcinoma of the Esophagogastric Junction

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Accuracy

    Time frame: intraoperative

    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.

Secondary outcomes

  1. Evaluation of R0 resection rate

    Time frame: 7days after the surgery

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

  2. Positive margin rate

    Time frame: 7days after the surgery

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

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

    Time frame: 7days after the surgery

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

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

    Time frame: 7days after the surgery

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

  5. Evaluation of the consistency between ES technique and frozen pathology

    Time frame: 7days after the surgery

    Evaluation of the consistency between ES technique and frozen pathology

  6. Postoperative recurrence: evaluate the anastomotic recurrence rate at 6, 12 months, and 2 years after surgery

    Time frame: 6, 12 months, and 2 years after surgery

    Postoperative recurrence: evaluate the anastomotic recurrence rate at 6, 12 months, and 2 years after surgery

  7. Evaluation of the time efficiency of ES and frozen pathology

    Time frame: 7days after the surgery

    ES real-time interpretation time vs frozen pathology result time

  8. Evaluate the number of timely adjustments to the resection range due to the interpretation of ES technology;

    Time frame: 7days after the surgery

    Evaluate the number of timely adjustments to the resection range due to the interpretation of ES technology;

Other outcomes

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

    Time frame: 7days after the surgery

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

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

An Exploratory, Parallel Controlled Study to Explore the Effectiveness of Intraoperative Margin Exploration Techniques for Adenocarcinoma of the Esophagogastric Junction

Important dates

Study start
2025
Primary completion
2026
Study completion
2028
First posted
Jul 31, 2025
Registry last updated
Jul 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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