Epiphora Due to Insufficient Drainage, Left Side Clinical Trial
Official title:
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
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.
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. Main end points: The rate of anastomotic leakage within 3 months after operation. Secondary endpoint: 1. Incidence rate and occurrence time of anastomotic stenosis after operation; 2. Reflux esophagitis; 3. R0 resection rate, minimally invasive conversion rate, operation time, bleeding volume, number of lymph nodes cleaned, number of lymph node cleaning stations, positive rate of lymph nodes, pathological stage, chest drainage volume, drainage tube placement time, gastric tube removal time, time to start eating after operation, and hospital stay. 4. Incidence rate of intraoperative accidents 5. Incidence rate of perioperative complications (pulmonary infection, cardiovascular complications, bleeding, chylothorax, pulmonary embolism, incision infection, etc.), rate of ICU transfer, and 30 day and 90 day mortality rate; 6. Quality of life (EORTC QLQ-C30, EORTC QLQ-OES18), nutritional status score and pain score in January, March, June and year after year; 7. Patient compliance, adverse event (AE) related to treatment, incidence and severity of serious adverse events; 8. 1, 2 and 3 year Progression free survival (PFS) and Overall survival (OS). ;