Esophageal carcinoma
Conditions
Interventions
Group A:Thoraco-laparoscopic Esophagectomy
Group B:Single-port Inflatable Mediastinoscopic Esophagectomy
Group C:Robot-assisted Minimally Invasive Esophagectomy
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Age: 18-75 years old, gender is not limited; 2) Locally advanced esophageal cancer after neoadjuvant therapy: (pre-treatment stage: T2N0M0, T1b-2N+M0, T3-4aNanyM0, resectable after treatment evaluation) 3)ECOG score :0-1; 4) ASA: Level I-III 5) Major organ function is normal, that is, meet the following criteria: (1) Blood routine examination: a.HB=90g/L; b.ANC=1.5×109/L; C. PLT =80×109/L; (2) Biochemical examination: A.LB =30g/L; B.lt and AST=2.5ULN; C.bil =1.5ULN; d. Plasma Cr=1.5ULN or creatinine clearance (CCr)=60ml/min; 6) Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) = the lower limit of normal value (50%); 7) Women of reproductive age should agree to use contraceptives (such as Iuds, contraceptives or condoms) during the study period and for 6 months after the study ends; Have a negative serum or urine pregnancy test within 7 days prior to study enrollment and must be a non-lactating patient; Men should consent to patients who must use contraception during the study period and for 6 months after the end of the study period; 8) The subjects voluntarily joined the study, signed the informed consent, had good compliance, and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1) Patients with contraindications related to neoadjuvant therapy. Such as: allergy to paclitaxel and platinum or metabolic disorders; Present with any active autoimmune disease or history of autoimmune disease (e.g., but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; The patient had vitiligo; Those with complete remission of asthma in childhood can be included without any intervention in adulthood; Patients with asthma requiring medical intervention with bronchodilators are not included); Patients who are taking immunosuppressants or systemic hormone therapy for immunosuppressive purposes (dose >10mg/ day of prednisone or other therapeutic hormone) and continue to use within 2 weeks prior to enrollment; Patients with any severe and/or uncontrolled disease, including: patients with unsatisfactory blood pressure control (systolic =150mmHg or diastolic =100 mmHg); Suffering from grade I or above myocardial ischemia or myocardial infarction, arrhythmias (including QT interval =480ms) and grade I cardiac insufficiency; Active or uncontrolled severe infection; Liver diseases such as decompensated liver disease, active hepatitis B (HBV-DNA=104 copy numbers /ml or 2000IU/ml), or hepatitis C (hepatitis C antibody positive and HCV-RNA above the lower detection limit of analytical methods); Urine routine indicated urine protein =++, and confirmed 24-hour urine protein quantity > 1.0g; 2) Pregnant or lactating women; 3) Patients who have had other malignancies within 5 years (except basal cell carcinoma of the skin and carcinoma in situ of the cervix that has been cured); 4) Patients who have a history of psychotropic drug abuse and cannot quit or have mental disorders; 5) Patients who have participated in clinical trials of other drugs within four weeks; 6) History of abdominal surgery; 7) Preoperative planning should be combined with excision of other organs, such as gallbladder, thyroid, liver, etc 8) Severe spinal deformity; 9) Patients with concomitant diseases (such as acute myocardial infarction, cerebral infarction, pulmonary embolism, etc.) that, according to the judgment of the investigator, seriously endanger the safety of the patient or affect the completion of the study; 10) Those deemed unsuitable for inclusion by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Perioperative complications;DFS;Intraoperative condition; | — |
Countries
China
Contacts
Public ContactLi Xiangnan
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed