Evaluation of Intra-operative Photographs for the Assessment of a Proper Lymphadenectomy in Minimally-invasive Gastric Cancer Surgery (PhotoNodes)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 326
- 试验地点
- 8
- 主要终点
- PhotoNode Score interobserver agreement
研究概览
简要总结
Even after the wide introduction of chemo/radiotherapy in the treatment algorithm, adequate surgery remains the cornerstone of gastric cancer treatment with curative intent. A proper D2 lymphadenectomy is associated with improved cancer specific survival as confirmed in Western countries by fifteen-year follow-up results of Dutch and Italian randomized trials.
In clinical practice, the total number of harvested lymph nodes is often considered as a surrogate marker for adequate D2 lymphadenectomy; nonetheless, the number of retrieved nodes does not necessarily correlate with residual nodes, which intuitively could represent a more reliable marker of surgical adequacy. The availability of an efficient tool for evaluating the absence of residual nodes in the operative field at the end of node dissection could better correlate with survival outcomes.
The goal of this multicentric observational prospective study is to test the reliability of a new score (PhotoNodes Score) created to rate the quality of the lymphadenectomy performed during minimally invasive gastrectomy for gastric cancer. The score is assigned by assessing the absence of residual nodes at the end of node dissection on a set of laparoscopic/robotic high quality intraoperative images collected from each patient undergoing a minimally invasive gastrectomy with D2 node dissection.
Ideally, this tool could be a new indicator of the quality of D2 dissection and could assume a prognostic role in the treatment of gastric cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •All patients undergoing minimally invasive curative-intent surgery for gastric adenocarcinoma with D2 lymphadenectomy
- •Patients undergoing upfront surgery or treated with a neoadjuvant/perioperative chemotherapy
- •Total or Subtotal Gastrectomy
- •Laparoscopic or Robotic approach
排除标准
- •Age less than 18 year old
- •Esophago-gastric junction cancer Siewert type I, II or III
- •Metastatic disease
- •Lymphadenectomy less than D2
- •Open surgery
- •Conversion to open surgery
- •Palliative gastrectomy
- •R1 or R2 resection
- •Multivisceral resection except for cholecystectomy
- •Surgical procedures other than subtotal or total gastrectomy
- •A single node station rated as unevaluable by more than one reviewer
结局指标
主要结局
PhotoNode Score interobserver agreement
时间窗: At the end of enrollment period
A PhotoNode Score for each patient will be obtained from each reviewer and the interobserver agreement among the reviewers will be analyzed. The range of the PhotoNodes Score will go from a minimum of 7 (poor lymphadenectomy) to a maximum of 24 (excellent lymphadenectomy)
次要结局
- Association between PhotoNode Score and disease-free, 1-year and 3-year overall survival(Data for follow up will be extracted through a 6-monthly medical chart review until 3 years after the end of enrollment period)
研究者
Federico Marchesi
Associate Professor of General Surgery - University of Parma
Azienda Ospedaliero-Universitaria di Parma