A Multicenter,Randomized Controlled Clinical Study of Minimally Invasive Intrathoracic Esophagogastric Side to Side Anastomosis vs. End to Side Anastomosis in the Treatment of Lower Esophageal Cancer or Esophageal Gastric Junction Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 402
- 试验地点
- 1
- 主要终点
- The rate of anastomotic leakage within 3 months after operation
研究概览
简要总结
On the basis of minimally invasive Ivor Lewis operation for the treatment of lower thoracic esophageal cancer or esophageal gastric junction cancer, the purpose of this study is to compare the probability of anastomotic leakage and stenosis after esophagogastric side to side anastomosis and esophagogastric end to side anastomosis, combined with the probability of complications, quality of life and survival rate of patients after the two anastomotic methods, To explore which anastomotic method is better than the worse for patients with lower thoracic esophageal cancer or cancer at the junction of esophagus and stomach. This study explored a minimally invasive anastomotic method with lower incidence of complications and higher quality of life for patients during Ivor Lewis surgery, which can increase the clinical benefits of patients, improve the quality of life, and extend the survival period, and has important clinical value.
详细描述
To carry out a multicenter, prospective, randomized controlled, phase III clinical study of minimally invasive Ivor Lewis operation for esophagogastric side to side anastomosis versus esophagogastric end to side anastomosis in the treatment of lower thoracic esophageal cancer or esophageal gastric junction cancer. Before grouping, introduce the similarities and differences of surgical methods to all patients, and group the patients who meet the conditions for inclusion through random control.
The specific groups are as follows:
Test group: intrathoracic esophagogastrostomy with minimally invasive Ivor Lewis operation
Control group: intrathoracic esophagogastric end-to-end anastomosis under minimally invasive Ivor Lewis operation
Each patient will be given a unique study number and will remain unchanged throughout the trial.
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
盲法说明
Esophagogastric Side to Side Anastomosis vs. End to Side Anastomosis
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The clinical staging of pathological and imaging diagnosis was cT1b-4a, N0-2, M0 stage of lower thoracic esophageal squamous cell carcinoma or Siewert type I and Siewert type II esophageal gastric junction adenocarcinoma (8th UICC-TNM staging);
- •The lesion is potentially resectable;
- •CT3-4a and/or N+patients receive neoadjuvant therapy with the informed consent of patients and their families
- •Comprehensive evaluation is suitable for Ivor Lewis operation
- •Aged 18-75 years, both male and female;
- •There was no contraindication in the preoperative examination and evaluation of various organ functions;
- •The following laboratory tests confirmed that the bone marrow, liver and kidney functions and blood coagulation met the requirements for participating in the study:
- •Hemoglobin ≥ 9.0g/L;
- •White blood cell count ≥ 4.0 × 109/L；
- •Absolute neutrophil count (ANC) ≥ 1.5 × 109/L；
- •Platelet count ≥ 100 × 109/L；
- •The international standardized ratio of prothrombin time ≤ 1.5 times the upper limit of normal value, and part of the thromboplastin time is within the range of normal value;
- •Serum creatinine (SCr) ≤ 1.5 times the upper limit of normal value or creatinine clearance ≥ 50 ml/min (Cockcroft Gault formula);
- •Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal value (ULN);
- •The level of AST or ALT ≤ 2.5 times the upper limit of normal value (ULN);
- •Urine protein<2+; If the urine protein ≥ 2+, the 24-hour urine protein quantitative display must be ≤ 1g;
- •Lung function: FEV1 ≥ 1.2L, FEV1% ≥ 50% and DLCO ≥ 50%
- •Estimated lifetime ˃ 12 months.
- •R0 resection is expected;
- •The color Doppler ultrasound of the neck showed no suspicious metastatic lymph nodes;
- •Generally in good condition, individual machine energy meter (Karnofsky score, KPS) ≥ 70; Physical status ECOG 0-2 points;
- •The subjects were fully informed of the purpose of the study, voluntarily joined the study, with good compliance, safety and survival follow-up.
排除标准
- •Patients with cervical and upper middle thoracic esophageal cancer or Siewert III esophageal gastric junction cancer;
- •Patients with T4b stage inoperable, multiple lymph node enlargement (estimated metastasis ≥ 3), multistation lymph node enlargement (estimated lymph node metastasis ≥ 2) or distant metastasis (M1);
- •Those who can not use stomach to replace esophagus in this operation due to previous operation
- •Previous history of other malignant tumors;
- •Pathological examination of non squamous and non adenocarcinoma patients;
- •Preoperative neoadjuvant chemotherapy and radiotherapy;
- •Severe emphysema and pulmonary fibrosis;
- •Confirmed history of congestive heart failure; Angina pectoris with poorly controlled medication; Transmural myocardial infarction confirmed by electrocardiogram (ECG); Poor control of hypertension; Valvular heart disease with clinical significance; Or high risk uncontrollable arrhythmia;
- •Serious uncontrolled systemic diseases, such as active infection or poorly controlled diabetes;
- •Abnormal coagulation function (PT>16s, APTT>43s, TT>21s, Fbg>2g/L), bleeding tendency (such as active peptic ulcer) or receiving thrombolytic or anticoagulant treatment;
- •Those who already have or are associated with hemorrhagic diseases;
- •People with peripheral nervous system disorder or obvious mental disorder and central nervous system disorder
结局指标
主要结局
The rate of anastomotic leakage within 3 months after operation
时间窗: 3 months
The rate of anastomotic leakage within 3 months after operation
次要结局
- Incidence rate and occurrence time of anastomotic stenosis after operation(3 months)
研究者
Peng Tang
Chief Physician, Department Director
Tianjin Medical University Cancer Institute and Hospital