Anastomotic Leak
Conditions
Interventions
Experimental group:Blood pressure maintenance with norepinephrine after esophageal cancer surgery
Sponsors
JiangSu Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Voluntary participation and written informed consent, good compliance and willingness to cooperate with follow-up; 2. Age >= 18 years and <= 85 years, regardless of gender; 3. Histopathologically confirmed esophageal cancer (Note: pathological diagnosis from other hospitals must be confirmed by our hospital’s pathology consultation); 4. Clinical stage T1-3N0-3M0 based on endoscopy, CT, MRI or PET-CT (including patients who received preoperative neoadjuvant therapy/conversion therapy and were downstaged to meet surgical criteria); 5. Willing to undergo radical resection for esophageal cancer; 6. ECOG performance status score of 0–1; 7. Females of childbearing potential must have a negative urine or serum pregnancy test within 72 hours before the first dose of study medication, and agree to use effective contraception during the study and for 5 months after the last dose. Males whose partners are of childbearing potential must use effective contraception during the study and for 7 months after the last dose.
Exclusion criteria
Exclusion criteria: 1. Patients with severe cardiopulmonary, hepatic, renal or other vital organ diseases who are unable to undergo esophageal cancer surgery; 2. Patients with contraindications to norepinephrine, including arteriosclerosis, hyperthyroidism, occlusive vasculitis, thrombosis, cocaine intoxication, and ischemic heart disease; 3. Patients with a history of esophagus, stomach, or esophagogastric junction surgery; 4. Any condition requiring systemic corticosteroid therapy (prednisone >10 mg/day or equivalent) or other immunosuppressive therapy within =9; 6. Major surgery or severe trauma within 4 weeks before the first dose of study medication; 7. Pregnant or lactating women, and subjects of childbearing potential unwilling or unable to use effective contraception; 8. Any other factors judged by the investigators that may lead to premature discontinuation, including other serious diseases (including mental illnesses) requiring concurrent treatment, recent serious diseases (such as myocardial infarction, cerebrovascular accident) with high recurrence risk, severe abnormal laboratory results, and family or social factors that may affect subject safety or data collection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of anastomotic leakage within 2 weeks after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of pulmonary infection within 2 weeks after surgery; | — |
Countries
China
Contacts
Public ContactRen Binhui
Thoracic Surgery, JiangSu Cancer Hospital
Outcome results
None listed