Intraoperative Margin Techniques for Esophagogastric Junction Adenocarcinoma: A Controlled Study

N/ANot Yet RecruitingNCT07095699

Fudan University314 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

314

Conditions

Adenocarcinoma of the Esophagogastric Junction

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Accuracy

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.

Time frame: intraoperative

Secondary Outcomes

Evaluation of R0 resection rate

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