Prospective Controlled Clinical Trial for Comparison of Tumor Efficacy Safety in Laparoscopic Resection of Gastrointestinal Stromal Tumors Between Favorable and Unfavorable Site（FUGES-016）
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- 3-year disease free survival rate
研究概览
简要总结
Participants with gastrointestinal stromal tumors(GIST) were divided into favorable and unfavorable sites according to the anatomical site of the tumor, and this study aims to validate the overall postoperative morbidity and mortality rates between favorable site receiving laparoscopic resection of GIST and that of unfavorable site under the currently standard surgical therapy.
详细描述
Participants with gastrointestinal stromal tumors(GIST) were divided into favorable and unfavorable sites according to the anatomical site of the tumor, and this study aims to validate the overall postoperative morbidity and mortality rates between favorable site receiving laparoscopic resection of GIST and that of unfavorable site under the currently standard surgical therapy. Main end of study: 3-year disease free survival rate
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Age between 18 and 75 years old
- •Primary gastric lesion confirmed pathologically GIST by endoscopic biopsy. Preoperative endoscopy, ultrasound endoscopy or computer tomography, Magnetic resonance suspected GIST, and then postoperative pathology confirmed as the original GIST
- •Written informed consent
- •Expected R0 resection by laparoscopy
- •Performance status of 0 or 1 on the ECOG (Eastern Cooperative Oncology Group) scale
- •ASA (American Society of Anesthesiology) class I to III
- •Maximum tumor diameter ≤10cm
排除标准
- •Pregnant and lactating women
- •Suffering from a severe mental disorder
- •History of previous upper abdominal surgery (except for laparoscopic cholecystectomy)
- •History of previous gastric surgery (including ESD/EMR for gastric cancer)
- •Rejection of laparoscopic resection
- •History of other malignant disease 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 another disease
- •Emergency surgery due to complications (bleeding, obstruction or perforation) caused by gastric cancer
- •FEV1<50% of the predicted values
- •Maximum tumor diameter >10cm
结局指标
主要结局
3-year disease free survival rate
时间窗: 36 months
Definition of recurrence and recurrence date The following situations are regarded as "recurrence" 1. Recurrence identified by any one image examination (X-ray, ultrasound, computed tomography, magnetic resonance imaging, etc.) and, if there are a variety of imaging examinations, results without contradiction determined "recurrence". The earliest date that the recurrence is found is defined as the "recurrence date". 2. For cases that lack the use of imaging or a pathological diagnosis, the date of diagnosing the occurrence of clinical recurrence based on clinical history and physical examination is defined as the "recurrence date". 3. For cases without imaging or clinical diagnosis but with a cytology or tissue biopsy pathological diagnosis of recurrence, the earliest date confirmed by cytology or biopsy pathology is considered the "recurrence date". 4. A rise in carcinoembryonic antigen or other associated tumor markers alone could not be diagnosed as a relapse.
次要结局
- Intraoperative morbidity rates(30 days)
- Conversion to open surgery rate(30 days)
- Positive surgical margin rate(30 days)
- 3-year overall survival rate(36 months)
- Time to first ambulation(30 days)
- Duration of postoperative hospital stay(30 days)
- Overall postoperative serious complications rates(30 days)
- 3-year recurrence pattern(36 months)
- Overall postoperative morbidity and mortality rates(30 days)
- Time to first flatus(30 days)
- Time to first liquid diet(30 days)
- Intraoperative tumor rupture rates(1 day)
- The variation of album(Preoperative 7 days and postoperative 1 and 5 days)
- The variation of hemoglobin(Preoperative 7 days and postoperative 1 and 5 days)
- Time to first soft diet(30 days)
- The variation of white blood cell count(Preoperative 7 days and postoperative 1 and 5 days)
- The variation of C-reactive protein(Preoperative 7 days and postoperative 1 and 5 days)
研究者
Chang-Ming Huang, Prof.
Professor
Fujian Medical University