Status:
RECRUITING
Total Intravenous Anesthesia and Recurrence Free Survival
Lead Sponsor:
The Cleveland Clinic
Conditions:
Esophageal Cancer
Eligibility:
All Genders
18-90 years
Phase:
PHASE3
Brief Summary
The investigators propose to compare recurrence-free survival in patients having potentially curative (Stages 1-3) surgery for esophageal cancer who will be randomly assigned to propofol-based total i...
Detailed Description
The investigators will test the primary hypothesis that recurrence-free survival after esophageal cancer surgery is longer in patients randomized to propofol-based total intravenous anesthesia than to...
Eligibility Criteria
Inclusion
- Primary esophageal cancer without known extension beyond the esophagus. (i.e. believed to be Tumor Stage 1-3).
- Scheduled for potentially curative esophageal cancer surgery.
- Written informed consent, including willingness to be randomized to intravenous versus volatile anesthesia.
Exclusion
- Previous surgery for esophageal cancer (except diagnostic biopsies) Age \<18 or \>85 years old.
- ASA Physical Status ≥4.
- Any contraindication to propofol or sevoflurane.
- Other cancer not believed by the attending surgeon to be in long-term remission.
- Systemic disease believed by the attending surgeon to present ≥25% two- year mortality.
Key Trial Info
Start Date :
August 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
1614 Patients enrolled
Trial Details
Trial ID
NCT04513808
Start Date
August 15 2020
End Date
December 1 2027
Last Update
December 4 2024
Active Locations (1)
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1
Shanhai Chest Hospital
Shanghai, China