A Phase Ⅲ Study of Respiratory Complications Associated With Esophagectomy Through Either Ivor-Lewis or Sweet Approach for the Treatment of Middle or Lower Third Intrathoracic Esophageal Carcinoma
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- morbidity of postoperative pulmonary complications
研究概览
简要总结
Worldwide, esophageal cancer is the 6th most common cause of cancer-related death. Currently curative resection remains the cornerstone of the therapy. Despite advances in anesthesia, operative techniques and postoperative management, postoperative pulmonary complications (PPCs) occur frequently accounting for about 30% of all postoperative complications. Most importantly, PPCs have much been associated with postoperative mortality. The diaphragm is the most important respiratory muscle and its respiratory function would be inevitably damaged when esophagectomy is performed through the left posterolateral thoracotomy (Sweet procedure) because the diaphragm must be dissected for the purpose of stomach moralization. Meanwhile, Ivor-Lewis approach may effectively avoid diaphragm injury because the stomach can be managed through a laparotomy whereas an additional abdomen incision is needed. Both procedures are routinely used in practice when surgically managing esophageal cancer. The investigators hypothesize that Ivor-Lewis procedure might be superior to the left-thoracotomy route during esophagectomy in preventing PPCs.
详细描述
Background:
Esophageal cancer is a common malignant tumor in China and worldwide with poor prognosis. Although the surgical resection combined with adjuvant therapy constitutes the mainstay of the treatment the esophagectomy-associated complications are still life-threatening. Postoperative pulmonary complications (PPCs), including pulmonary infection, atelectasis, edema and ARDS (acute respiratory distress syndrome) are the leading causes of the eventful postoperative episodes.
The diaphragm is the well known essential respiratory muscle whose normal function guarantees more than 30% of pulmonary function. Esophagectomy through left thoracotomy would inevitably cut off the left diaphragm for the abdominal procedure and thus greatly damage the diaphragmatic function. It has been assumed that Ivor-Lewis esophagectomy would save the pulmonary function to a great extent by retaining the intact diaphragm but the addition of a laparotomy would be unavoidable. However, this hypothesis has not been confirmed by any randomized controlled trial with adequate operation volume. At present, a large part of thoracic surgeons, for example in China, still prefer esophagectomy through Sweet approach believing that it is less traumatic. So far, there is presently no convincing evidence to guide the esophagectomy approach selection on the aspect of prevention of PPCs.
Objectives:
- To compare the PPCs rates after Ivor-Lewis esophagectomy and Sweet esophagectomy
- To compare the degrees of diaphragm function deficiencies between two groups.
- To compare the pulmonary function results between two groups
- To compare the degrees of gastric emptying between two groups
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Biopsy or cytology confirmed esophageal carcinoma.
- •No-contraindication to surgery.
- •Tumor locates at middle or lower thoracic esophagus (e.g. below the level of azygos vein according to AJCC cancer staging manual, esophageal and esophagogastric junctional cancer, 7th edition, 2009), so that the anastomosis could be completed within the thorax
- •Informed consent.
排除标准
- •Patients with low performance status (ECOG score > 1)
- •Refuse to participate
- •History of adjuvant chemo and/or radiotherapy
- •History of malignancy
- •Previous abdominal and/or thoracic surgery
- •History of pleural disease with obvious pleural adhesion on X-ray examination
- •Contraindication to any of the planned intervention procedure
- •Age of ≥ 70 years
结局指标
主要结局
morbidity of postoperative pulmonary complications
时间窗: within 10 postoperative days
次要结局
- diaphragm movement, pulmonary function, stomach emptying(within 10 postoperative days)