Intraoperative Margin Techniques for Esophagogastric Junction Adenocarcinoma: A Controlled Study

Официальное название

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

Обзор

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.

Вмешательства

• Устройство 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.

Первичные конечные точки

• Accuracy [Срок оценки: intraoperative]

Вторичные конечные точки (8)

• Evaluation of R0 resection rate [Срок оценки: 7days after the surgery]
• Positive margin rate [Срок оценки: 7days after the surgery]
• Evaluation of the actual resection margin distance during ES-assisted AEG [Срок оценки: 7days after the surgery]
• Evaluate the sensitivity, specificity, PPV, and NPV of ES technology [Срок оценки: 7days after the surgery]
• Evaluation of the consistency between ES technique and frozen pathology [Срок оценки: 7days after the surgery]
• Postoperative recurrence: evaluate the anastomotic recurrence rate at 6, 12 months, and 2 years after surgery [Срок оценки: 6, 12 months, and 2 years after surgery]
• Evaluation of the time efficiency of ES and frozen pathology [Срок оценки: 7days after the surgery]
• Evaluate the number of timely adjustments to the resection range due to the interpretation of ES technology; [Срок оценки: 7days after the surgery]

Критерии участия

Критерии включения

• 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;

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07095699 · 20250308

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗