Not Yet RecruitingNot Applicable

Intraoperative Margin Techniques for Esophagogastric Junction Adenocarcinoma: A Controlled Study

314 participantsStarted 2025-08-15

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Accuracy

Timeframe: intraoperative

Trial details

NCT IDNCT07095699

SponsorFudan University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05-31