Efficacy of Narrow Band Imaging Technique for Identifying Resection Margin Status After Gastrectomy for Gastric Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Accuracy for identifying the status of resection margin
研究概览
简要总结
As the proportion of early gastric cancer has been steadily increased in Korea, so has function-preserving surgery. The function preserving surgery is characterized by the minimized extent of gastrectomy, so this implies that bilateral margins are getting shorter than those of standard gastrectomies.
Currently, there is only one way to identify resection margin status in gastric cancer, 'frozen biopsy'. However, it is labor-intensive and time-consuming procedure. In addition, the results rely on the pathologist's expertise, thereby it showed limitation of its accuracy; high false negative rate of signet ring cell carcinoma was reported in a previous study.
Recently, many studies on magnifying endoscopy with narrow band imaging(NBI) demonstrated that this emerging technique is useful to identify the gastric tumor margin more clearly in vivo, compared with conventional indigocarmine chromoendoscopy. So it was hypothesized that NBI may allow reliable delineation of tumor and identification of resection margin status in the specimen after gastrectomy for gastric cancer.
详细描述
- Tumor delineation and identification of resection margin:
After specimen delivery from the abdomen, frozen biopsy is performed before checking tumor margin. After inspection with NBI, the tumor margin is marked with electrocauterization. The tumor size and the lengths of both resection margins are evaluated using a ruler. 2. Pathologic examination:
The specimen is sliced as 4mm interval paralleled to the markings. Tumor size, the status of both resection margins, and microvessel density are evaluated under the 200 magnified view.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient from over 20 to under 90 years
- •The patient who is diagnosed as gastric cancer clinically by endoscopy or computed tomography
- •The patient who is informed and consent about the purpose and contents of this study prior to the participation in this study
排除标准
- •The patient who shows far advanced gastric cancer preoperatively or intraoperatively
- •The patient with previous medical history of other treatment for gastric caner such as endoscopic resection, chemotherapy, radiation, immunotherapy, and so on
结局指标
主要结局
Accuracy for identifying the status of resection margin
时间窗: 2 weeks
The status of resection margin assessed by NBI during the operation is confirmed by the pathologic examination at postoperative 2 weeks
次要结局
- Tumor size(2 weeks)
- Microvessel density(4 weeks)
研究者
Sang-Uk Han
Professor, Department of Surgery, Ajou University School of Medicine
Ajou University School of Medicine