Esophageal Cancer
Conditions
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 intravenous anesthesia or sevoflurane-based balanced general anesthesia.
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 volatile sevoflurane anesthesia. The investigators will test the secondary hypotheses that propofol-based total intravenous anesthesia: 1) speeds discharge from the ICU; 2) speeds discharge from the hospital; and, 3) improves the quality of recovery, as assessed by QoR-15 on postoperative day 2.
Interventions
DRUGPropofol-based total intravenous anesthesia
Propofol-based total intravenous anesthesia, titrated to clinical need.
DRUGSevoflurane intravenous anesthesia
Sevoflurane intravenous anesthesia, titrated to clinical need.
Sponsors
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Intervention model description
As usual with time-to-event outcomes, enrollment will be based on the number of outcome events, not the number of patients enrolled. We anticipate that about 1614 patients will be required to generate 579 recurrences and/or deaths, but this is only a rough estimate since follow-up duration is a function of when patients are enrolled, not just their number.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence-free survival | 4 years | Patients who did not experience cancer recurrence and/or death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ICU duration | From ICU admission until the date of ICU discharge or date of death from any cause, whichever came first, assessed up to 100 months | Postoperative time in ICU during initial admission. |
| Hospital duration | Up to 100 months | Postoperative time spent in hospital during initial admission. |
| QoR-15 | 2 days | Quality of Recovery 15 score on postoperative day 2. |
Countries
China
Contacts
CONTACTYuwei Qiu, MD
PRINCIPAL_INVESTIGATORYuwei Qiu, MD
Shahai Hospital
Outcome results
None listed