Multicenter Phase III Trial of Laparoscopic Sentinel Node Biopsy and Stomach Preserving Surgery in Early Gastric Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 580
- 试验地点
- 7
- 主要终点
- 3 year disease free survival rate
研究概览
简要总结
Laparoscopic sentinel lymph node biopsy and stomach preserving surgery in early gastric cancer is less invasive method which can increase quality of life. For last two years, multicenter quality control study (Phase II) has been performed in Korea and tolerable results were observed. Based on these results, multicenter phase III trial is required to validate the clinical role of laparoscopic sentinel lymph node biopsy.
详细描述
The final analyses include the modified intention to treatment analysis (full analysis set) and Per Protocol analysis (including patients who underwent assigned surgery without agreement withdrawal).
- Injection of tracer and sentinel basin dissection
- Tracer: Tc 99m HSA (Human serum albumin, 2ml, 0.1mCi/ml) + ICG (indocyanine green, 2ml, 5mg/ml)
- Endoscopic injection of tracer on 4 sites around gastric cancer
- Identification of sentinel basin using laparoscopic probe (Neoprobe)
- Laparoscopic sentinel basin dissection and identification of sentinel node at back table
- Surgical considerations
- If positive sentinel nodes were diagnosed in frozen section, conventional gastrectomy is performed.
- If micrometastasis or isolate tumor cells in sentinel basin lymph nodes were diagnosed in the permanent pathology, re-operation of conventional gastrectomy is not performed.
- However, re-operation of converntional gastrectomy should be performed in case of macrometastasis, deep and lateral margin positive, more than pT2 lesion in the permanent pathology.
- H.pylori eradication - There was no clear evidence that H.pylori eradication reduced development of metachronous gastric cancer. H.pylori eradication was planned to perform according to physician's decision or patient's need. However, recently, the effect of H.pylori eradication in development of metachronous gastric cancer was published in NEJM (Choi et al. 2018). Therefore, from now on, H. pylori eradication will be recommended to enrolled patients with H.pylori.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •single lesion of adenocarcinoma in preoperative endoscopic biopsy
- •clinical stage T1N0 in the preoperative evaluation of endoscopy and computed tomography
- •tumor size: less than 3cm
- •location: 2cm far from the pylorus or cardia
- •aged 20 to 80
- •ECOG 0 or 1
- •patient who signed the agreement
- •patient who is suspected to underwent laparoscopy assisted gastrectomy
排除标准
- •indication of endoscopic submucosal resection
- •inoperable due to poor cardiac, pulmonary function
- •having allergic reaction, previous upper abdominal surgery except laparoscopic cholecystectomy, previous radiation therapy to upper abdomen
- •diagnosed as malignancy within 5 years except carcinoma in situ of cervix cancer and thyroid cancer
结局指标
主要结局
3 year disease free survival rate
时间窗: 3 years after surgery
A total of enrollment period is suspected to be four years and patients will be followed up for five years. However, primary end point is 3 year disease free survival and we can analyze survival data at three year later from when the last enrolled patients underwent intervention.
次要结局
- 5 year disease free survival rate(5 years after surgery)
- 3 year overall survival rate(3 years after surgery)
- postoperative morbidity and mortality(30 days after surgery)
- 5 year disease specific death rate(5 years after surgery)
- scores of global health status scale, functional scales, and symptom scales/items of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30 and STO22(3 years)
- 5 year overall survival rate(5 years after surgery)
- 3 year recurrence free survival rate(3 years after surgery)
- 5 year recurrence free survival rate(5 years after surgery)
- 3 year disease specific death rate(3 years after surgery)
研究者
Keun Won Ryu
Principal investigator
National Cancer Center, Korea