NCT07095699Not yet recruiting
Intraoperative Margin Techniques for Esophagogastric Junction Adenocarcinoma: A Controlled Study
An Exploratory, Parallel Controlled Study to Explore the Effectiveness of Intraoperative Margin Exploration Techniques for Adenocarcinoma of the Esophagogastric Junction
Source: ClinicalTrials.gov · Last updated 31 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 314 (estimated)
- First submitted
- 23 Jul 2025
- Start date
- 15 Aug 2025
- Primary completion date
- 31 May 2026
- Lead sponsor
- Fudan University
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT07095699
What you commit to
- Study type: Interventional
- Planned participants: 314
- From 15 Aug 2025 to the primary completion date, 31 May 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participated in other clinical trials of research drugs or devices in the past month;
Other illness
- Patients with severe cardiovascular or circulatory system diseases and cannot tolerate surgery;
- Patients who are unable to complete follow-up due to mental illness, cognitive or emotional disorders;
Lab values
- Patients who are allergic to methylene blue and fluorescein sodium;
Other
- Unable to understand the test requirements or unable to complete the study follow-up plan;
- Pregnant and lactating women;
- Subjects who are considered by the researchers to be unsuitable for participating in the study.
Who the study is looking for
- 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;
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.