Total Intravenous Anesthesia and Recurrence Free Survival

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

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.

Study Overview

• Status: Recruiting
• Conditions: Esophageal Cancer
• Intervention / Treatment: Drug: Propofol-based total intravenous anesthesia; Drug: Sevoflurane intravenous 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.

• Study Type: Interventional
• Enrollment (Estimated): 1614
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Fabio Rodriquez Patarroyo, MD; Phone Number: ‭(216) 444-9674‬; Email: Rodrigf3@ccf.org
• Study Contact Backup: Name: Daniel I Sessler, MD; Phone Number: 216-870-2620; Email: DS@CCF.org

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Shanhai Chest Hospital
    • Contact: Yuwei Qui, MD; Email: qqiuyuweixk@163.com
    • Contact: Yuwei

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Propofol-based total intravenous anesthesia; 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; Propofol-based total intravenous anesthesia, titrated to clinical need.; Other Names: Propofol
Active Comparator: Sevoflurane intravenous anesthesia; 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; Sevoflurane intravenous anesthesia, titrated to clinical need.; Other Names: Sevoflurane

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Yuwei Oui, MD, Shahai Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2020
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: May 12, 2020
• First Submitted That Met QC Criteria: August 12, 2020
• First Posted (Actual): August 14, 2020

Study Record Updates

• Last Update Posted (Actual): November 15, 2023
• Last Update Submitted That Met QC Criteria: November 13, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Disease Attributes; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Recurrence; Esophageal Neoplasms; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Platelet Aggregation Inhibitors; Hypnotics and Sedatives; Anesthetics, Inhalation; Anesthetics; Propofol; Sevoflurane
• Other Study ID Numbers: VICTORY

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be shared collaboratively with appropriate approvals and contracts.
• IPD Sharing Time Frame: 2 years after publication of the main paper.
• IPD Sharing Access Criteria: Contact investigators.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No