Long Outcome of Endoscopic Submucosal Dissection for Small Gastrointestinal Stromal Tumors (<2cm) :a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 90
- 主要终点
- progression-free survival
研究概览
简要总结
Data are currently insufficient to guide the management of very small gastrointestinal stromal tumors（GISTs）（< 2 cm) discovered incidentally on endoscopy,this study is designed to collect the medical records of patients in different treatment group with long-term follow-up data,and attempts to evaluate the usefulness of regular endoscopic ultrasound（EUS）surveillance and the necessity,safety and feasibility of endoscopic submucosal dissection（ESD）for small GISTs,thus provide evidence for the revision of the guideline.
详细描述
OBJECTION:to evaluate the usefulness of regular endoscopic ultrasound（EUS） surveillance and the necessity,safety and feasibility of endoscopic submucosal dissection（ESD） for small GISTs(<2cm),thus providing evidences for the revision of the guideline.
OUTLINE:This is a randomized controlled trial. Eligible patients are divided into 2 group with 45 in each.The experimental group undergo ESD for GISTs,while the investigators do no treatment to the control group.Then,the 2 groups will be follow up for 5 years.All data are analysed with the Statistical Product and Service Solutions（SPSS）statistical software.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female chinese patients of 18-70 years old.
- •Patients with very small gastric GISTs (< 2 cm) with no high-risk EUS features.
- •Patients voluntarily join this study with informed consents.
排除标准
- •Patients with the tumors involving the serosa layer or grow outside the lumen obviously that are not eligible for endoscopic treatment.
- •Patients with distant metastasis on computed tomography(CT)scan.
- •patients with an extremely poor general condition or a very short life expectancy.
- •Patients presenting with severe gastrointestinal tract bleeding that require immediate surgery.
结局指标
主要结局
progression-free survival
时间窗: 5 years
It is the time that passes from a patient is enrolled in this clinical trial to the date on which disease "progresses" or the date on which the patient dies, from any cause.
次要结局
- Operation time(At surgery)
- Peri-operative bleeding(At surgery)
- Complications rate(At surgery)
- tumor recurrence rate(5 years)
- success rate of operations(At surgery)
- Tumor progression rates(5 years)
- Duration of hospitalization and the total hospital costs(through the whole recovery, an average of 10 days)
- Histological curative resection(At surgery)
- patient satisfaction scores(5 years)