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Not yet recruiting NCT07095699

Intraoperative Margin Techniques for Esophagogastric Junction Adenocarcinoma: A Controlled Study

No phase Interventional Adenocarcinoma of the Esophagogastric Junction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: EndoSCell System.
Who it may be relevant to
Registry conditions: Adenocarcinoma of the Esophagogastric Junction. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Device 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.

Primary outcome measures

  • Accuracy [Time frame: intraoperative]
Secondary outcome measures (8)
  • Evaluation of R0 resection rate [Time frame: 7days after the surgery]
  • Positive margin rate [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]
  • Evaluation of the consistency between ES technique and frozen pathology [Time frame: 7days after the surgery]
  • 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]
  • Evaluation of the time efficiency of ES and frozen pathology [Time frame: 7days after the surgery]
  • Evaluate the number of timely adjustments to the resection range due to the interpretation of ES technology; [Time frame: 7days after the surgery]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07095699 · 20250308

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗