Minimally Invasive Intrathoracic Esophagogastric Side to Side Anastomosis vs. End to Side Anastom… (NCT05812495) | Clinical Trial Compass
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Minimally Invasive Intrathoracic Esophagogastric Side to Side Anastomosis vs. End to Side Anastomosis
China402 participantsStarted 2023-03-01
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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:
✕. 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;