Total Intravenous Anesthesia and Recurrence Free Survival

Study Overview
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Brief Summary
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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
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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.

Official Title
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Total IntraVenous AnesthesIa and ReCurrence-free Survival AfTer EsOphageal CanceR SurgerY

Conditions
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Esophageal Cancer

Intervention / Treatment
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* Drug: Propofol-based total intravenous anesthesia
* Drug: Sevoflurane intravenous anesthesia


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Propofol-based total intravenous anesthesia<br>Propofol-based total intravenous anesthesia. A target-controlled infusion will be set to 2-4 µg/ml plasma concentrations, and varied as clinical necessary. | Drug: Propofol-based total intravenous anesthesia<br>* Propofol-based total intravenous anesthesia, titrated to clinical need.<br>* Other names: Propofol;|
| Active Comparator: Sevoflurane intravenous anesthesia<br>Anesthesia will be maintained with sevoflurane, typically at an end-tidal concentration of 0.6-1.0 MAC, but adjusted as clinically necessary | Drug: Sevoflurane intravenous anesthesia<br>* Sevoflurane intravenous anesthesia, titrated to clinical need.<br>* Other names: Sevoflurane;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence-free survival | Patients who did not experience cancer recurrence and/or death. | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU duration | Postoperative time in ICU during initial admission. | From ICU admission until the date of ICU discharge or date of death from any cause, whichever came first, assessed up to 100 months | 
| Hospital duration | Postoperative time spent in hospital during initial admission. | Up to 100 months | 
| QoR-15 | Quality of Recovery 15 score on postoperative day 2. | 2 days |