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Total Intravenous Anesthesia and Recurrence Free Survival

Primary Purpose

Esophageal Cancer

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Propofol-based total intravenous anesthesia
Sevoflurane intravenous anesthesia
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shanhai Chest HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Propofol-based total intravenous anesthesia

Sevoflurane intravenous anesthesia

Arm Description

Propofol-based total intravenous anesthesia. A target-controlled infusion will be set to 2-4 µg/ml plasma concentrations, and varied as clinical necessary.

Anesthesia will be maintained with sevoflurane, typically at an end-tidal concentration of 0.6-1.0 MAC, but adjusted as clinically necessary

Outcomes

Primary Outcome Measures

Recurrence-free survival
The investigators will use the randomized groups to descriptively compared on all baseline variables using summary statistics such as mean and standard deviation, median and quartiles or frequency and percent, as appropriate.

Secondary Outcome Measures

The treatment effect of propofol-based anesthesia versus volatile anesthesia.
The investigators will use a Cox proportional hazards time to event model to assess the treatment effect.

Full Information

First Posted
May 12, 2020
Last Updated
September 7, 2022
Sponsor
The Cleveland Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT04513808
Brief Title
Total Intravenous Anesthesia and Recurrence Free Survival
Official Title
Total IntraVenous AnesthesIa and ReCurrence-free Survival AfTer EsOphageal CanceR SurgerY
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 15, 2020 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Cleveland Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
950 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Propofol-based total intravenous anesthesia
Arm Type
Active Comparator
Arm Description
Propofol-based total intravenous anesthesia. A target-controlled infusion will be set to 2-4 µg/ml plasma concentrations, and varied as clinical necessary.
Arm Title
Sevoflurane intravenous anesthesia
Arm Type
Active Comparator
Arm Description
Anesthesia will be maintained with sevoflurane, typically at an end-tidal concentration of 0.6-1.0 MAC, but adjusted as clinically necessary
Intervention Type
Drug
Intervention Name(s)
Propofol-based total intravenous anesthesia
Intervention Description
Patients will normally be given dexamethasone 10 mg and ramosetron 0.3-0.6 mg prophylaxis for postoperative nausea and vomiting. Rescue treatment will be provided per clinical routine. Post-operative analgesia will be opioid-based, typically sufentanil and dezocine via patient-controlled pump. Analgesic adjuvants will be used per clinician preference.
Intervention Type
Drug
Intervention Name(s)
Sevoflurane intravenous anesthesia
Intervention Description
Patients will normally be given dexamethasone 10 mg and ramosetron 0.3-0.6 mg prophylaxis for postoperative nausea and vomiting. Rescue treatment will be provided per clinical routine. Post-operative analgesia will be opioid-based, typically sufentanil and dezocine via patient-controlled pump. Analgesic adjuvants will be used per clinician preference.
Primary Outcome Measure Information:
Title
Recurrence-free survival
Description
The investigators will use the randomized groups to descriptively compared on all baseline variables using summary statistics such as mean and standard deviation, median and quartiles or frequency and percent, as appropriate.
Time Frame
4 years
Secondary Outcome Measure Information:
Title
The treatment effect of propofol-based anesthesia versus volatile anesthesia.
Description
The investigators will use a Cox proportional hazards time to event model to assess the treatment effect.
Time Frame
up to 2 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Sessler, MD
Phone
216-444-4900
Email
ds@or.org
First Name & Middle Initial & Last Name or Official Title & Degree
Roberta Johnson
Phone
216-444-9950
Email
johnsor13@ccf.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuwei Oui, MD
Organizational Affiliation
Shahai Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanhai Chest Hospital
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roberta Johnson
Phone
216-444-9950
Email
johnsor13@ccf.org
First Name & Middle Initial & Last Name & Degree
Yuwei Qui, MD
Email
qqiuyuweixk@163.com

12. IPD Sharing Statement

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Total Intravenous Anesthesia and Recurrence Free Survival

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