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Impact of Total Intravenous Anesthesia Following Cancer Surgery, TIVACS Study

Primary Purpose

Pancreatic Adenocarcinoma

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Anesthesia Procedure
General Anesthesia Procedure
Resection
Sponsored by
Ohio State University Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Adenocarcinoma

Eligibility Criteria

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

Inclusion Criteria:

  • Adults: >= 18 years
  • Diagnosed with pancreatic adenocarcinoma
  • Presented for surgery between January 1, 2021 and December 31, 2023
  • Able to provide consent

Exclusion Criteria:

  • Allergies to study anesthetic - intravenous Propofol, or a history of malignant hyperthermia to volatile inhaled anesthetics
  • Prisoner status

Sites / Locations

  • Ohio State University Comprehensive Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm I (surgical resection with TIVA)

Arm II (surgical resection with inhaled volatile anesthetics)

Arm Description

Patients undergo surgical resection with TIVA.

Patients undergo surgical resection with inhaled volatile anesthetics.

Outcomes

Primary Outcome Measures

Impact of anesthetic agent on inflammation and immunosuppression
All data analysis will use Student's t-test, Chi2 test and multivariable regression analysis using linear mixed model. The incidence of these outcomes will also be associated with NET levels.

Secondary Outcome Measures

Impact of anesthetic choice on short-term anesthetic and surgical outcomes
All data analysis will use Student's t-test, Chi2 test and multivariable regression analysis using linear mixed model. The incidence of these outcomes will also be associated with NET levels.

Full Information

First Posted
July 28, 2021
Last Updated
June 26, 2023
Sponsor
Ohio State University Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT04992507
Brief Title
Impact of Total Intravenous Anesthesia Following Cancer Surgery, TIVACS Study
Official Title
The Impact of Total Intravenous Anesthesia Following Cancer Surgery (TIVACS) Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 2, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University Comprehensive Cancer Center

4. Oversight

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

5. Study Description

Brief Summary
This phase II trials studies the impact of total intravenous anesthesia (TIVA) following cancer surgery. Surgery and the anesthesia delivered causes physiologic stress and trauma resulting in immune suppression. TIVA is an alternative method of general anesthesia that has several benefits over volatile inhalation agents such as reducing nausea, vomiting, and opioid consumption, and promotes earlier return of bowel function following surgery. In addition, TIVA is less immunosuppressive than inhalational agents and has been shown to decrease cancer cell proliferation, migration, and metastasis formation. Giving TIVA during cancer-directed abdominal surgery may decrease the immunosuppressive state in the peri-surgical period.
Detailed Description
PRIMARY OBJECTIVE: I. To evaluate the impact of anesthetic agent on inflammation and immunosuppression among patients undergoing abdominal cancer surgery. SECONDARY OBJECTIVE: I. To determine the impact of anesthetic choice on short-term anesthetic and surgical outcomes. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients undergo surgical resection with TIVA. ARM II: Patients undergo surgical resection with inhaled volatile anesthetics. After completion of study treatment, patients are followed up for up to 5 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Adenocarcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm I (surgical resection with TIVA)
Arm Type
Experimental
Arm Description
Patients undergo surgical resection with TIVA.
Arm Title
Arm II (surgical resection with inhaled volatile anesthetics)
Arm Type
Active Comparator
Arm Description
Patients undergo surgical resection with inhaled volatile anesthetics.
Intervention Type
Procedure
Intervention Name(s)
Anesthesia Procedure
Other Intervention Name(s)
Anesthesia
Intervention Description
Given TIVA
Intervention Type
Drug
Intervention Name(s)
General Anesthesia Procedure
Other Intervention Name(s)
General Anesthesia
Intervention Description
Given inhaled volatile anesthetics
Intervention Type
Procedure
Intervention Name(s)
Resection
Other Intervention Name(s)
Surgical Resection
Intervention Description
Undergo surgical resection
Primary Outcome Measure Information:
Title
Impact of anesthetic agent on inflammation and immunosuppression
Description
All data analysis will use Student's t-test, Chi2 test and multivariable regression analysis using linear mixed model. The incidence of these outcomes will also be associated with NET levels.
Time Frame
Up to 5 years
Secondary Outcome Measure Information:
Title
Impact of anesthetic choice on short-term anesthetic and surgical outcomes
Description
All data analysis will use Student's t-test, Chi2 test and multivariable regression analysis using linear mixed model. The incidence of these outcomes will also be associated with NET levels.
Time Frame
Up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults: >= 18 years Diagnosed with pancreatic adenocarcinoma Presented for surgery between January 1, 2021 and December 31, 2023 Able to provide consent Exclusion Criteria: Allergies to study anesthetic - intravenous Propofol, or a history of malignant hyperthermia to volatile inhaled anesthetics Prisoner status
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
The Ohio State University Comprehensive Cancer Center
Phone
800-293-5066
Email
OSUCCCClinicaltrials@osumc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aslam Ejaz, MD
Organizational Affiliation
Ohio State University Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aslam Ejaz, MD
Phone
614-293-7171
Email
Aslam.Ejaz@osum.edu
First Name & Middle Initial & Last Name & Degree
Aslam Ejaz, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://cancer.osu.edu
Description
The Jamesline

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Impact of Total Intravenous Anesthesia Following Cancer Surgery, TIVACS Study

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