A Prospective, Multicenter Cohort Study on the Efficacy and Safety of Laparoscopic Resection of 5cm or Larger Gastric Gastrointestinal Stromal Tumors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 194
- 试验地点
- 1
- 主要终点
- Overall postoperative morbidity
研究概览
简要总结
The purpose of this study is to explore the safety of laparoscopic resection of 5cm or larger gastric gastrointestinal stromal tumors
详细描述
There is a lack of high-quality evidence on the efficacy and safety of laparoscopic resection of gastric GIST over 5cm. A multicenter, prospective cohort study was conducted to evaluate the clinical efficacy of laparoscopic resection of 5cm or larger gastric gastrointestinal stromal tumors (GIST) compared to laparoscopic resection of GIST of less than 5cm. The primary evaluation parameter is overall postoperative morbidity.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years < age < 75 years
- •Primary gastric lesion diagnosed as gastric GSIT by endoscopic biopsy histopathology or suspected gastric GIST by preoperative endoscopy, ultrasound endoscopy, or CT or MR, and confirmed as primary gastric GIST by postoperative pathology
- •Patient informed consent and willingness to undergo laparoscopic resection
- •Expected laparoscopic outcome of R0 resection
- •Performance status: Eastern Cooperative Oncology Group (ECOG) ≤ 2, Preoperative American Society of Anesthesiologists（ASA） score I-III
排除标准
- •Women during pregnancy or breast-feeding
- •Severe mental disorder
- •History of upper abdominal surgery (except the history of laparoscopic cholecystectomy)
- •History of gastric surgery (except ESD/EMR for gastric cancer)
- •History of other malignant diseases within the past five years
- •History of unstable angina or myocardial infarction within the past six months
- •History of a cerebrovascular accident within the past six months
- •History of continuous systematic administration of corticosteroids within one month
- •Requirement of simultaneous surgery for other diseases
- •Emergency surgery due to complications (bleeding, obstruction, or perforation) caused by gastric cancer
结局指标
主要结局
Overall postoperative morbidity
时间窗: 30 days after surgery or the first discharge ( if over 30 days hospital stay)
This is for the incidence of early postoperative complications, which defined as the event observed within 30 days after surgery.
次要结局
- The variation of white blood cell count(Preoperative 7 days and postoperative 1, 3, and 5 days)
- Positive surgical margin rate(1 day)
- The variation of hemoglobin(Preoperative 7 days and postoperative 1, 3, and 5 days)
- Time to first flatus(30 days)
- intraoperative morbidity rates(1 day)
- Conversion to open surgery rate(1 day)
- The variation of C-reactive protein(Preoperative 7 days and postoperative 1, 3, and 5 days)
- 3-year recurrence pattern(36 months)
- Time to first ambulation(30 days)
- Time to first liquid diet(30 days)
- Duration of postoperative hospital stay(30 days)
- overall postoperative serious morbidity rates(30 days after surgery or the first discharge ( if over 30 days hospital stay))
- Time to first soft diet(30 days)
- 3-year disease free survival rate(36 months)
- 3-year overall survival rate(36 months)
研究者
Chang-Ming Huang, Prof.
Director, Head of Department of Gastric Surgery, Principal Investigator, Clinical Professor
Fujian Medical University