NCT07095699尚未招募不适用
An Exploratory, Parallel Controlled Study to Explore the Effectiveness of Intraoperative Margin Exploration Techniques for Adenocarcinoma of the Esophagogastric Junction
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 314
- 主要终点
- Accuracy
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
排除标准
- •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.
结局指标
主要结局
Accuracy
时间窗: intraoperative
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.
次要结局
- Evaluation of the consistency between ES technique and frozen pathology(7days after the surgery)
- Postoperative recurrence: evaluate the anastomotic recurrence rate at 6, 12 months, and 2 years after surgery(6, 12 months, and 2 years after surgery)
- Evaluation of the time efficiency of ES and frozen pathology(7days after the surgery)
- Evaluate the number of timely adjustments to the resection range due to the interpretation of ES technology;(7days after the surgery)
- Evaluation of R0 resection rate(7days after the surgery)
- Positive margin rate(7days after the surgery)
- Evaluation of the actual resection margin distance during ES-assisted AEG(7days after the surgery)
- Evaluate the sensitivity, specificity, PPV, and NPV of ES technology(7days after the surgery)
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