COmpletion Sentinel Node Resection With or Without Minimally invAsive and Endoscopic Cooperative Surgery Following noncuRative Endoscopic Submucosal Dissection for Early Gastric Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Severe complications defined as Clavien-Dindo >/= III
研究概览
简要总结
For patients with non-curative resection after endoscopic submucosal dissection (ESD) for early gastric cancer (EGC), complementary surgery is generally recommended. However, about 2/3 of patients have no remaining tumor in the stomach or regional lymph nodes. In this trial, Indocyanine Green (ICG)-guided lymphadenectomy with or without laparoscopic and endoscopic cooperative surgery (LECS) will be tested as a less invasive alternative in such cases. For patients with a primary radically resected EGC, ICG-guided lymphadenectomy alone will be performed. For patients with deep-margin positive EGC, ICG-guided lymphadenectomy and LECS will be performed, in order to ensure both local tumor control in the stomach and in regional nodes.
详细描述
Endoscopic submucosal dissection (ESD) is the recommended treatment for early gastric cancer (EGC) who are fullfillling the criteria based on international guidelines. After ESD, some resections are classified as non-curative because of factors such as non radicality (especially when the deep margin is positive for cancer), lymphovascular invasion or deep submucosal invasion Sm>1. In such cases, guidelines recommend complementary gastrectomy and lymphadenectomy. Gastrectomy is known to carry a risk for severe complications in about 9-22 % of cases. Furthermore, up to 2/3 of patients are found to have no remaining tumor in the stomach or regional nodes after surgery.
In this trial, Indocyanine Green (ICG)-guided lymphadenectomy including sentinel node resection, with or without complementary laparoscopic and endoscopic cooperative surgery (LECS) will be tested as a less invasive treatment option. For patients with radically resected EGC, ICG-guided lymphadenectomy alone will be performed. In patients with deep margin positive EGC, ICG-guided lymphadenectomy and LECS will be performed.
ICG-guided lymphadenectomy is performed by first injecting 100 times diluted ICG in four quadrants in the submucosa around the tumor scar with gastroscopy. After 15 minutes, the draining nodes will be visualized with laparoscopy, and locally resected. LECS is performed by endoscopic marking of the scar followed circumferential mucosal cutting, trimming, and perforation of the stomach followed by full-thickness resection of the scar with laparoscopy. After resection, the resected specimen will be taken out and the stomach defect sutured laparoscopically.
After the procedure, the patient will be presented at a multidisciplinary tumor board. If only clinical follow-up is recommended, the patient will be followed closely with gastroscopy and computer tomography (CT) scan every 3 months for the first year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •EGC previously treated with ESD according to current guidelines (differentiated adenocarcinoma, not ulcerative, of any size, differentiated adenocarcinoma ulcerative </=3cm, undifferentiated adenocarcinoma not ulcerative </=2cm)
- •Non curative resection
- •Lymphovascular invasion
- •Non-radical resection vertical margin
- •deep submucosal invasion
- •Signed informed consent
排除标准
- •Location within 2 cm from cardia or pylorus
- •Non-curative resection with only non-radicality horizontal margin
- •Inoperative because of severe comorbidities
- •Previous radiotherapy to the upper abdomen
- •Pregnancy
- •Allergy to ICG
- •Inability to provide informed consent due to cognitive impairment, language barrier, or other reasons impairing understanding and autonomous decision-making.
结局指标
主要结局
Severe complications defined as Clavien-Dindo >/= III
时间窗: Periprocedural
Safety of the procedure, defined as Clavien-Dindo complication grade \>/= III
次要结局
- Operation time(Periprocedural)
- Any complications(Periprocedural)
- Postoperative bleeding(Periprocedural)
- Leakage(Periprocedural)
- Pathological tumor (T)-stage(Up to 2 months post procedure)
- Tumor-free resection margins(Up to 2 months post procedure)
- Number of lymph nodes(Periprocedural)
- Number of positive lymph nodes(Up to 2 months post procedure)
- Hospital-stay(From the day of the procedure until patient is discharged from the hospital, assessed up to 12 weeks post procedure)
- Health-related quality of life (HQL) score QLQ-30(Preoperatively, after 30 days and 1 year)
- Health-related quality of life (HQL) score OG25(Preoperatively, after 30 days and 1 year)
- 30-day mortality(From procedure to maximum 30 days postoperatively)
- In-hospital mortality(From the day of the procedure until patient is discharged from the hospital, assessed up to 12 weeks post procedure)
- 1-year disease-free survival(Until 1 year after the procedure)
研究者
Ioannis Rouvelas
Principal Investigator, MD, PhD
Region Stockholm