Mid- and Long-term Surgical and Oncological Outcomes of Total Laparoscopic Gastrectomy for Gastric Cancer: A Prospective Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Disease-free survival at three years
研究概览
简要总结
A prospective study of the results of laparoscopic approach of gastric carcinoma in western patients is designed. The working hypothesis proposes obtaining similar results to those obtained in the series reported by eastern hospitals (Japan and Korea) and, at least, equivalent to those recorded in conventional surgery.
详细描述
This is a single-center prospective study. All gastric adenocarcinoma patients operated on between January 2004 and December 2022 who underwent laparoscopic resection with D1-D2 lymphadenectomy were considered.
The exclusion criteria were patients who were lost to follow-up, were unfit for surgery, underwent palliative surgery or had T4b lesions or gastric neoplasms other than adenocarcinoma.
The preoperative evaluation included laboratory tests, upper digestive endoscopy with biopsy, computed tomography scans (chest, abdomen, and pelvis), and endoscopic ultrasound in selected cases.
The tumor node, metastasis (TNM) protocol of the College of American Pathologists was used for staging In the preoperative workup, the patients were classified according to the American Anesthesiology Association (ASA).
Perioperative and postoperative complications will be classified according to the Clavien-Dindo system.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed of gastric adenocarcinoma fit for surgical treatment.
排除标准
- •patients who were lost to follow-up
- •patients unfit for surgery
- •palliative surgery
- •T4b lesions
- •neoplasms other than adenocarcinoma
结局指标
主要结局
Disease-free survival at three years
时间窗: Three years.
Rate of patients who reach this condition
Disease-free survival at five years
时间窗: Five years
Rate of patients who reach this condition
次要结局
- Three years overall survival(Three years.)
- Five years overall survival(Five years)
研究者
Juan Carlos Martín del Olmo
MD, PhD. Associate Professor Valladolid University.
Hospital Medina del Campo