A Single-center, Single-arm Clinical Study Evaluating the Short-term Efficacy of Inflatable Mediastinoscopic-assisted Transhiatal Laparoscopic Esophagectomy for the Radical Resection of Thoracic Esophageal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
研究概览
简要总结
Abstract Background China has a high incidence of esophageal cancer, with surgery being the primary treatment modality. While the right thoracic approach for radical esophagectomy remains the standard surgical method, it is associated with a significant rate of postoperative complications. Given that the esophagus is a posterior mediastinal organ, a mediastinal approach for radical esophagectomy without thoracotomy could potentially reduce postoperative complications. However, this hypothesis has yet to be validated by prospective clinical studies. To explore this further, we conducted a single-center, single-arm clinical study to assess the short-term efficacy of inflatable video-assisted mediastinoscopic transhiatal esophagectomy (IVMTE) combined with laparoscopy for the treatment of thoracic esophageal cancer.
Methods In this prospective, single-arm phase II clinical trial, 35 patients with cTis-3N0M0 thoracic esophageal squamous cell carcinoma (ESCC) were enrolled between March 2021 and September 2023. All patients underwent radical esophagectomy using IVMTE. The primary endpoint of the study was the overall surgical complication rate, while secondary endpoints included the R0 resection rate, the extent and number of lymph nodes dissected, the 1-year disease-free survival (DFS) rate, and the 1-year overall survival (OS) rate. To evaluate the outcomes, propensity score matching (PSM) analysis was performed, comparing the results with 70 cTis-3N0M0 ESCC patients who underwent minimally invasive McKeown esophagectomy (MIME) using a thoracoscopic-laparoscopic approach during the same period (March 2021 to September 2023).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •The patient has not undergone any prior anti-tumor treatment, including chemotherapy, radiotherapy, targeted therapy, immunotherapy, or other anti-tumor treatments;
- •The patient has been histopathologically confirmed and diagnosed with esophageal squamous cell carcinoma, including obtaining pathological specimens through fiberoptic esophagoscopy biopsy, endoscopic mucosal dissection, endoscopic mucosal resection, and other methods, and confirmed by pathological examination as thoracic esophageal squamous cell carcinoma (including adequate diagnosis by immunohistochemical staining);
- •The patient has undergone comprehensive preoperative evaluation (including plain and enhanced computed tomography (CT) scans of the neck, chest, and abdomen, plain and enhanced magnetic resonance imaging (MRI) scans of the chest, endoscopic ultrasonography, fiberoptic bronchoscopy, and neck ultrasound), and the clinical stage, according to the Tumor-node-metastasis Classification (TNM staging), is cT1b-3N0M0 or cTis-1aN0M0, and the patient is not suitable for endoscopic resection (TNM staging according to the American Joint Committee on Cancer 8th edition staging system);
- •The patient is aged between 18 and 70 years;
- •The patient's hematology (including routine blood cell count, routine liver and kidney function tests, blood lipids, blood glucose, electrolyte levels, tumor markers, etc.) and organ function (liver, kidney, heart, etc.) are normal;
- •The patient can understand this study and has signed the informed consent form.
- •The patient has good cardiopulmonary function (left ventricular ejection fraction between 50-80%; forced expiratory volume in one second (FEV1) >80% of predicted value).
排除标准
- •Patients with severe calcification of the aorta;
- •Patients with severe spinal deformities;
- •Female patients during pregnancy or lactation;
- •Patients who have undergone subtotal gastrectomy or total gastrectomy and cannot use the stomach to replace the esophagus;
- •Patients who have undergone anti-tumor treatment (including chemotherapy, radiotherapy, surgery);
- •Patients who have existing or concurrent significant bleeding disorders;
- •Other uncontrollable and inoperable conditions;
- •Patients with cervical spondylosis;
- •Patients who lack informed consent due to psychological, family, social, or other factors;
- •Patients with two or more primary malignant tumors at the same time;
- •Patients who, after thorough evaluation, have severe cardiac, pulmonary, hepatic, renal dysfunction, or other conditions that make surgery intolerable;
- •Patients with a history of diabetes for more than 10 years and whose blood glucose levels are not satisfactorily controlled.
研究者
Qianwen Liu
Professor
Sun Yat-sen University