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Total Intravenous Anesthesia and Recurrence Free Survival

NCT ID: NCT04513808

Last Updated: 2024-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

1614 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-15

Study Completion Date

2027-12-31

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.

Conditions

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Esophageal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Propofol-based total intravenous anesthesia

Intervention Type DRUG

Propofol-based total intravenous anesthesia, titrated to clinical need.

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

Group Type ACTIVE_COMPARATOR

Sevoflurane intravenous anesthesia

Intervention Type DRUG

Sevoflurane intravenous anesthesia, titrated to clinical need.

Interventions

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Propofol-based total intravenous anesthesia

Propofol-based total intravenous anesthesia, titrated to clinical need.

Intervention Type DRUG

Sevoflurane intravenous anesthesia

Sevoflurane intravenous anesthesia, titrated to clinical need.

Intervention Type DRUG

Other Intervention Names

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Propofol Sevoflurane

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Cleveland Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yuwei Oui, MD

Role: PRINCIPAL_INVESTIGATOR

Shahai Hospital

Locations

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Shanhai Chest Hospital

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Daniel I Sessler, MD

Role: CONTACT

[email protected]
216-870-2620

Fabio Rodriquez Patarroyo, MD

Role: CONTACT

[email protected]
‭(216) 444-9674‬

Facility Contacts

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Yuwei Qui, MD

Role: primary

[email protected]

Yuwei

Role: backup

Other Identifiers

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VICTORY

Identifier Type: -

Identifier Source: org_study_id