Total Intravenous Anesthesia and Recurrence Free Survival

Esophageal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04513808
• Other study ID #: VICTORY
• Status: Recruiting
• Phase: Phase 3
• Start date: August 15, 2020
• Est. completion date: December 2027

Study information

• Verified date: November 2023
• Source: The Cleveland Clinic
• Contact: Daniel I Sessler, MD
• Phone: 216-870-2620
• Email: DS[@]CCF.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1614
• Est. completion date: December 2027
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms
• Recurrence

Intervention

Drug:
• Propofol-based total intravenous anesthesia
Propofol-based total intravenous anesthesia, titrated to clinical need.
• Sevoflurane intravenous anesthesia
Sevoflurane intravenous anesthesia, titrated to clinical need.

Locations

Country	Name	City	State
China	Shanhai Chest Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence-free survival	Patients who did not experience cancer recurrence and/or death.	4 years
Secondary	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
Secondary	Hospital duration	Postoperative time spent in hospital during initial admission.	Up to 100 months
Secondary	QoR-15	Quality of Recovery 15 score on postoperative day 2.	2 days