Intraoperative Margin Techniques for Esophagogastric Junction Adenocarcinoma: A Controlled Study

Launched by FUDAN UNIVERSITY · Jul 23, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new imaging tool called the EndoScell Scanner (ES) to see if it can help surgeons better identify cancer-free edges (margins) during surgery for cancer where the esophagus meets the stomach (called adenocarcinoma of the esophagogastric junction, or AEG). The goal is to find out if this new tool works as well as the standard method, which involves quickly freezing and examining tissue during surgery. Researchers also want to know if using ES can speed up the surgery and reduce the need for taking extra tissue to make sure all cancer is removed.

People who may be eligible to join are adults diagnosed with this specific type of cancer and who are planning to have surgery to remove it. To participate, patients must agree to the study and be able to follow-up with doctors for up to two years after surgery. During the trial, participants will have their surgery as usual but will be randomly assigned to have their tissue margins checked either by the new ES system or by the standard frozen-section method. Tissue samples will be collected and studied using several methods to compare results. The study is currently not recruiting, and certain people—such as those allergic to specific dyes used in the study, those with serious heart problems, or pregnant women—will not be eligible. This trial hopes to improve how surgeons ensure all cancer is removed during surgery, which could lead to better outcomes for patients.

Gender

ALL

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.