Esophageal carcinoma
Conditions
Interventions
Cohort A:Y-shaped hand-sewn layered anti-reflux anastomosis:Y-shaped hand-sewn layered anti-reflux anastomosis. The adventitia and muscular layer of the esophagus, as well as the seromuscular layer of
Cohort B:Circular stapled anastomosis: Circular stapled anastomosis. An end-to-side anastomosis between the esophagus and the gastric tube is performed using a conventional circular stapler.
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age: 18-80 years old, gender is not limited; 2. Esophageal cancer in the middle and lower thoracic segment: the tumor is located below 25cm of the incisor or below the level of the tracheal carina (to ensure sufficient surgical margins); 3. The lesion is resectable after neoadjuvant or translational therapy (no of the following: T4b tumor with aortic, airway, or vertebral body invasion, macromassive fusion lymph nodes, and distant metastasis); 4. Proposed posterior mediastinal tract reconstruction; 5. ECOG score: 0-1 6. Normal function of major organs, that is, meeting the following criteria: (1) Routine blood examination: 1)HB>=90g/L; 2)ANC>=1.5×10^9/L; 3)PLT >=80×10^9/L; (2) Biochemical examination: 1)ALB>=30g/L; 2) ALT and AST=60ml/min; 7. Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) >=low limit of normal (50%); 8. Women of childbearing potential should agree to use contraceptive measures (such as intrauterine devices, birth control pills, or condoms) during the study and for 6 months after the end of the study; Negative serum or urine pregnancy test within 7 days prior to study enrollment and must be non-lactating patients; Men should agree that they must practice contraception during the study and for 6 months after the end of the study period. 9. Subjects voluntarily join this study, sign the informed consent form, have good compliance, and cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Women who are pregnant or breastfeeding; 2. Patients unable to cooperate with quality of life assessments; 3. Patients who have had other malignant tumors within the past 5 years (except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix); 4. Patients with a history of substance abuse of psychiatric medications who are unable to quit, or patients with psychiatric disorders; 5. Patients who have participated in other clinical trials within the past four weeks that may affect the assessment of study data, such as drug trials with potential side effects; 6. Severe spinal deformities; 7. Patients who, in the investigator’s judgment, have serious comorbidities that endanger safety or affect the completion of the study (such as acute myocardial infarction, cerebral infarction, pulmonary embolism, etc.); 8. Patients deemed unsuitable for inclusion by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anastomotic leakage;Incidence of adverse events (AEs) , serious adverse events (SAEs),; | — |
Secondary
| Measure | Time frame |
|---|---|
| Postoperative reflux symptoms;R0 Resection Rate;Operative time (defined as the total duration from the initial surgical incision to the complete suture closure of the final incision),;Intraoperative blood loss; | — |
Countries
China
Contacts
Public ContactLi Xiangnan
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed