Endoscopic Submucosal Tunnel Dissection Versus Video-assisted Thoracoscopic Surgery for Upper Gastrointestinal Submucosal Tumors: a Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- En bloc resection
研究概览
简要总结
The purpose of this study is to determine the efficacy and safety of endoscopic submucosal tunnel dissection (ESTD) compared with video-assisted thoracoscopic surgery (VATS) in the treatment of upper gastrointestinal submucosal tumors.
详细描述
Most upper gastrointestinal submucosal tumors (SMTs), especially the gastrointestinal stromal tumors (GISTs) and leiomyoma, are regarded as benign if they are less than 3cm in size. Thus, it has been suggested that patients should receive periodic endoscopic follow-up in case of gradual changes in size; however this can be stressful and troublesome for patients. Nevertheless, some of these tumors do have a malignant potential, and management by periodic endoscopic surveillance may lead to delayed diagnosis of malignancy. Therefore, it is necessary to remove the SMTs.
To date, several approaches have been used for the treatment of upper gastrointestinal SMTs, including open, thoracoscopic and laparoscopic surgery, and endoscopic approaches such as band ligation, endoscopic submucosal dissection (ESD), and endoscopic full-thickness resection (EFR). However, the surgical approaches are invasive with a longer hospital stay and greater cost, while the endoscopic approaches were limited by technical difficulty, incomplete resections and risk of perforation.
Recently, the technique of peroral endoscopic myotomy (POEM) for esophageal achalasia was introduced, a procedure in which a submucosal tunnel is created to expose and dissect the circular muscle of the esophagus. Inspired by the POEM approach, we have successfully used a similar method, endoscopic submucosal tunnel dissection (ESTD), to resect SMTs in upper gastrointestinal.
However, the long-term efficacy and safety of ESTD were not determined, and there was no prospective study compared the ESTD with other conventional approaches. Therefore, we plan to conduct this prospective randomized controlled trial, aim to determine the efficacy and safety of ESTD, compared with the pneumatic dilation, in the treatment of upper gastrointestinal SMTs originating from the muscularis propria layer .
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
- 15 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 18 and 75 years of age
- •Patient with upper gastrointestinal submucosal tumor
- •Signed informed consent
排除标准
- •Severe cardio-pulmonary disease or other serious disease leading to unacceptable surgical risk
- •Endoscopic ultrasound (EUS) or CT signs of metastasis
- •Mega-oesophagus (greater than 7 cm) or Oesophageal diverticula in the distal oesophagus
- •Previous oesophageal or gastric surgery
- •Pregnancy or lactation women, or ready to pregnant women
- •Not capable of filling out questionnaires
结局指标
主要结局
En bloc resection
时间窗: During the operation
The En bloc resection was defined as a one-piece resection of the entire lesion without fragmentation
次要结局
- Curative resection(From date of randomization until the date of pathological diagnosis, an expected average of 7 days)
- Procedure related complication(From date of operation until the occurrence of the procedure related complication, which most occur within 7 days after operation, assessed up to 2 years)
- Short-term morbidity(From date of randomization until the date of death from any cause, assessed up to 3 months)
- Local recurrence(From date of randomization until the follow-up ended, assessed up to 2 years)
- Quality of life(From date of randomization until the follow-up ended, assessed up to 2 years)