A Phase Ⅲ Study of Left Side Thoracotomy Approach (Sweet Procedure) Versus Right Side Thoracotomy Plus Midline Laparotomy Approach (Ivor-Lewis Procedure) Esophagectomy in Middle or Lower Third Intrathoracic Esophageal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Disease free survival
研究概览
简要总结
This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-2001. Esophageal carcinoma is an aggressive disease with a poor prognosis. Surgical resection remains the basic method of management of this malignancy. Although different approaches have been described for the surgical resection of esophageal cancer, there is no statistical evidence based on large scale prospective randomized trials with regard to the issue that which is the optimal surgical approach for esophageal cancer. The purpose of this study is to test two different approach of transthoracic esophagectomy (Right Side Thoracotomy plus Midline Laparotomy Approach: Ivor-Lewis Procedure and Left Side Thoracotomy Approach: Sweet Procedure) in middle or lower third intrathoracic esophageal cancer. This research is being done to see whether one approach is superior than the other approach with better long-term outcome and acceptable postoperative short-term outcome or not.
详细描述
Background :
Esophageal carcinoma is an aggressive disease with a poor prognosis. Surgical resection remains the basic method of management of this malignancy. Although different approaches have been described for the surgical resection of esophageal cancer, there is no statistical evidence based on large scale prospective randomized trials with regard to the issue that which is the optimal surgical approach for esophageal cancer. In middle or lower third intrathoracic esophageal cancer, a great number of thoracic surgeon preferred the Ivor-Lewis Procedure(Right Side Thoracotomy plus Midline Laparotomy Approach), and believe that this approach can get better exposure for the upper mediastinal node dissection so can get the better long-term survival. But some others preferred the Sweet Procedure(Left Side Thoracotomy Approach),especially in china, more than two of the third unit performed the left side approach esophagectomy routinely and the long-term survival was reported equal to even better than the right side approach. The purpose of this study is to conduct a large scale prospective randomized Phase Ⅲ clinical trial to test that based on the long-term outcomes(overall survival and disease free survival )and postoperative short-term outcomes(mortality, morbidity),whether one approach is superior than the other approach or not.
Objectives:
- To compare overall survival after right side approach and left side approach esophagectomy
- To compare locoregional recurrence, disease free survival after right side approach and left side approach esophagectomy
- To compare postoperative morbidity and mortality in the two groups
- To evaluate short and long term quality of life after the two procedures
Design: Prospective randomized controlled
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
- •Patients with histologically proven squamous cell esophageal cancer
- •Patients with cT1-T3/N0-N1 mid or distal third (inferior to carina and 3cm superior to cardia ) operable esophageal lesion. Staging investigations including esophagogastroscopy, chest and abdominal CT scan, barium swallow and selective endoscopic ultrasonography showing no evidence of invading adjacent structure such as spine, bronchus, pericardium , descending aorta and without enlargement cervical and celiac nodes (diameter of short axis greater than 1.5cm) measured at CT scans.
- •Karnofsky performance status greater than or equal to 80%
- •Pulmonary and cardiac function must be acceptable for surgery according to institutional standards.
- •Acceptable hepatic, renal and bone marrow function
排除标准
- •Patients with low performance status(Karnofsky score <80%)
- •Past history of malignancy
- •Stage investigations indicating unresectable advanced disease(T4 or M1a,M1b)
- •Patients with any other serious underlying medical condition that would impair the ability of the patient to receive or comply with protocol treatment
- •Patients medically unfit for surgical resection
- •Patients with pulmonary reserve inadequate to undergo thoracotomy and extensive mediastinal lymphadenectomy.
- •Patients with a significant history of unstable cardiovascular disease that in the opinion of the treating physician should preclude the patient from protocol treatment.
- •Uncontrolled diabetes mellitus or uncontrolled infection, including HIV or interstitial pneumonia or interstitial fibrosis.
- •Significant psychiatric illness that would interfere with patient compliance
- •Patients with severe hepatic cirrhosis or with serious renal disease unacceptable for surgery
- •Patients considered of salvage surgery after definitive chemoradiotherapy
- •Patients after neoadjuvant chemoradiotherapy
- •Patients above the age of 75 years
- •Patients unreliable for follow up
结局指标
主要结局
Disease free survival
时间窗: 6 years
次要结局
- Locoreginal recurrence and recurrence pattern(6 years)
- Overall survival(6 years)
- postoperative morbidity and mortality(3 years)
研究者
Haiquan Chen
Chief, Department of thoracic surgery
Fudan University