Three Field Radical Esophagectomy Versus Two Field Esophagectomy - a Prospective Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 700
- 试验地点
- 2
- 主要终点
- Overall survival
研究概览
简要总结
Surgery is the standard treatment for esophageal (food pipe) cancer. Esophageal cancer is known to spread to the lymph nodes (glands) adjacent to the esophagus. The extent of lymph nodes that need to be removed along with removal of the esophagus is a controversial topic. The basic surgery will remain the same i.e., the foodpipe in the chest will be removed and a new substitute will be created from the stomach and joined to the foodpipe in the neck. This will involve incisions in the chest, abdomen and neck. We intend to compare two types of lymphadenectomy (removal of lymph nodes) - the two field lymphadenectomy, whereby the lymph nodes in the abdomen and the lower half of the chest will be removed and three field lymphadenectomy, wherein lymph nodes in the abdomen, the whole chest and the lower neck will be removed. Both these procedures are practised widely worldwide and there is no definite scientific evidence showing the superiority of either of them. We are conducting this study to see whether one of these procedures is superior to the other. Seven hundred patients are expected to participate in this study.
详细描述
Three field radical esophagectomy versus two field esophagectomy - a prospective randomized controlled trial
Background Esophageal cancer is a common problem worldwide and is associated with poor prognosis. Surgery is the mainstay of treatment and offers the only realistic possibility of cure and long term survival. Neoadjuvant and adjuvant chemotherapy and radiotherapy have been tried in addition to surgery and have only marginally impacted on survival. In spite of advancements in postoperative care and refinements in surgical technique, overall results with surgery have been disappointing. Moreover studies of neoadjuvant and adjuvant therapy have been confounded by the lack of a uniform surgical approach and extent of lymphadenectomy.
The efficacy of prophylactic radical lymph node dissection in surgical treatment of esophageal cancer has been a topic of major controversy for many years. It has not been studied in a randomized controlled trial with adequate numbers. Non randomized studies have been criticized on the basis of selection bias and stage migration. There is presently no convincing evidence regarding improvement in survival by extensive three field lymphadenectomy.
Objectives
- To compare overall survival after three field and two field esophagectomy
- To compare locoregional recurrence, disease free survival after three field and two field esophagectomy
- To compare postoperative morbidity and mortality in the two groups
- To evaluate short and long term quality of life after the two procedures
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 biopsy or cytology proven (squamous or adenocarcinoma) esophageal cancer
- •Patients with staging investigations showing operability
- •Surgical plan of total transthoracic esophagectomy
排除标准
- •Patients with low performance status (ECOG score>1)
- •Past history of malignancy
- •Staging investigations indicating advanced disease
- •Patients medically unfit for surgical resection
- •Patients with pulmonary reserve inadequate to undergo thoracotomy and extensive mediastinal lymphadenectomy
- •Patients considered for salvage surgery after definitive (radical)chemoradiotherapy
- •Patients with supracarinal lymph node enlargement on CT scan and/or EUS
- •Patients intraoperatively detected to have grossly enlarged supracarinal lymph nodes
- •Patients with Siewert's type III CO junction growths
- •Patients above the age of 70 years
- •Patients unreliable for follow up
结局指标
主要结局
Overall survival
次要结局
- Disease-free survival
- Quality of Life