the Prospective, Randomized and Comparative Clinical Study of Laparoscopic and Endoscopic Cooperative Surgery in the Treatment of Gastrointestinal Stromal Tumor
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Tumor recurrence rate
研究概览
简要总结
Gastric stromal tumor is a gastrointestinal mesenchymal tumor with malignant differentiation potential, the incidence increased year by year. The surgical resection is the primary treatment for it. Although laparoscopic GIST resection has many benefits，due to in lack of the delicate sense of touch, it could lead to the incomplete resection and disorders of digestion. More than 33% of postoperative patients have the gastric dysfunction. Laparoscopic endoscopy combined surgery is different from the past technology. It is a new radical resection of GIST presented by Japanese scholars. LECS resects the tumor completely by laparoscopy with the help of the precise positioning and guidance of endoscopy .This method conforms to the idea of the modern minimally invasive surgery, and avoids many problems，such as incomplete resection and disorders of digestion caused by excessive tissue resection. our team will spearhead the GIST treatment of LECS. First of all, the investigators will collect 120 cases of GIST patients, randomly assigned for the laparoscopic group, the LECS, single-arch the LECS surgical treatment. Secondly, to analyzing the basic treatment and follow-up data, including the operation time, blood loss, the number of transfer laparotomy, the number of cut edge positive, the distances of cut edge away from the tumor edge, the cases of anastomotic fistula bleeding, stenosis, average such confinement, the meal time, cost of treatment, tumor recurrence rate, the presence of residual stomach, upset stomach and frequency, reflux esophagitis, bile reflux gastritis and other indicators.The purpose of this subject is to observe the effectivity and safety of LECS and single-arch the LECS, invent serval LECS equipment patents and provide some references for LECS applying to the minimally invasive surgery of the digestive tract tumor and multidisciplinary treatment mode .
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
- Double (Participant, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients without contraindications gastroscope，surgery and anesthesia;
- •Gastroscope found submucosal lesions, qualitative hard;Endoscopic ultrasonography (EUS) confirmed the lesions come from the muscularis propria
- •Tumors diameter > 2 cm;Or tumors had < 2 cm, but the position is located in the stomach wall, after nearly cardia and it is a difficult position for gastroscope ;
- •Tumors diameter < 5 cm, the tumors had complete, no broken feed and bleeding
- •Not found the tumor metastasis
- •There is no history of abdominal surgery, no severe abdominal cavity adhesion
- •Patients signed informed consent
排除标准
- •Patients with preoperative assessment of distant metastasis;
- •Patients with preoperative radiation and chemotherapy or hormone therapy;
- •Patients with acute obstruction, bleeding or perforation of the emergency surgery
- •Patients with a history of abdominal trauma or abdominal surgery.
- •Patients with contraindications gastroscope，surgery and anesthesia;
研究组 & 干预措施
Laparoscopic surgery
Laparoscopic endoscopy combined surgery. This is a kind of traditional surgical method.
干预措施: Laparoscopic endoscopy combined surgery (Procedure)
laparoscopic and endoscopic
LECS resects the tumor completely by laparoscopy with the help of the precise positioning and guidance of endoscopy .
干预措施: laparoscopic and endoscopic cooperative surgery (Procedure)
Single-arch laparoscopic and endoscopic
Single-arch LECS resects the tumor completely by laparoscopy with the help of the precise positioning and guidance of endoscopy
干预措施: Single-arch laparoscopic and endoscopic cooperative surgery (Procedure)
结局指标
主要结局
Tumor recurrence rate
时间窗: 2 years
次要结局
- the operation time(one hour-five hours)
- the all number of postoperative complications（ frequency,reflux esophagitis and bile reflux gastritis）(2 years)