Pancreatic AdenocarcinomaPhase 2NCT04992507
Impact of Total Intravenous Anesthesia Following Cancer Surgery, TIVACS Study
A Phase 2 study testing Anesthesia Procedure, General Anesthesia Procedure and Resection in people with Pancreatic Adenocarcinoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Adenocarcinoma
- What is being tested?
- Anesthesia Procedure, General Anesthesia Procedure and Resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jun 2023to 26 Jan 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults: ≥18 years old on the day of consent
- Non-metastatic pancreatic adenocarcinoma
- Able to provide consent
- ECOG performance status of 0 or 1
- Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test for the patient at the time of surgery.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Previous identified allergy or hypersensitivity to any component of the study treatment
- Allergies to eggs, egg products, soybeans, or soy products
- Personal or first degree relative with a history of malignant hyperthermia
- Has a known additional malignancy that is expected to require active treatment within two years, or is likely to be life-limiting in the opinion of the treating investigator. Superficial bladder cancer, non-melanoma skin cancers, or low-grade prostate cancer not requiring therapy would not exclude participation in this trial.
- Uncontrolled intercurrent illness including, but not limited to: Symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant or lactating females
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- Major surgery within 2 months before enrollment. Complete healing from major surgery must have occurred 1 month before enrollment. Complete healing from minor surgery (eg, simple excision, tooth extraction) must have occurred at least 7 days before enrollment. Subjects with clinically relevant complications from prior surgery are not eligible.
- Patients who undergo reoperation during their initial hospitalization will be censored at the time of reoperation.
- Prisoner status
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
Official title: The Impact of Total Intravenous Anesthesia Following Cancer Surgery (TIVACS) Study
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.
Read the detailed description
PRIMARY OBJECTIVE:
- To evaluate the impact of anesthetic agent on inflammation and immunosuppression among patients undergoing abdominal cancer surgery.
SECONDARY OBJECTIVE:
- 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 2 years.
- Conditions
- Pancreatic Adenocarcinoma
- Being tested
- Anesthesia Procedure, General Anesthesia Procedure, Resection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anesthesia ProcedureProcedure or surgery
Also called Anesthesia
Given TIVA
General Anesthesia ProcedureDrug
Also called General Anesthesia
Given inhaled volatile anesthetics
ResectionProcedure or surgery
Also called Surgical Resection
Undergo surgical resection
| Study group | Role | What they receive |
|---|---|---|
| Arm I (surgical resection with TIVA) | Experimental | Patients undergo surgical resection with TIVA. Receives: Procedure: Anesthesia Procedure; Procedure: Resection |
| Arm II (surgical resection with inhaled volatile anesthetics) | Active comparator | Patients undergo surgical resection with inhaled volatile anesthetics. Receives: Drug: General Anesthesia Procedure; Procedure: Resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 2 years
Secondary outcomes (1)
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.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start2 Jun 2023
- Primary completion26 Jan 2024
- Study completion26 Jan 2024
Why it stopped: Principal investigator departed sponsoring organization
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pancreatic AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aslam Ejaz, MD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04992507
- Sponsor's protocol ID
- OSU-20306
- Other IDs
- NCI-2021-05849
- Status last verified
- Jun 2025
- First submitted
- 28 Jul 2021
- Last updated
- 10 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Total Intravenous Anesthesia Following Cancer Surgery (TIVACS) Study
- ClinicalTrials.gov ID
- NCT04992507
- Acronym / sponsor ID
- OSU-20306
- Conditions
- Pancreatic Adenocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Principal investigator departed sponsoring organization
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 2 Jun 2023 (actual)
- Primary completion
- 26 Jan 2024 (actual)
- Study completion
- 26 Jan 2024 (actual)
- First posted
- 5 Aug 2021 (actual)
- Results
- Posted 10 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To evaluate the impact of anesthetic agent on inflammation and immunosuppression among patients undergoing abdominal cancer surgery.
SECONDARY OBJECTIVE:
- 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 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (surgical resection with TIVA) | Experimental | Procedure: Anesthesia Procedure, Procedure: ResectionPatients undergo surgical resection with TIVA. |
| Arm II (surgical resection with inhaled volatile anesthetics) | Active comparator | Drug: General Anesthesia Procedure, Procedure: ResectionPatients undergo surgical resection with inhaled volatile anesthetics. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults: ≥18 years old on the day of consent
- Non-metastatic pancreatic adenocarcinoma
- Able to provide consent
- ECOG performance status of 0 or 1
- Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test for the patient at the time of surgery.
Key exclusion criteria (9 listed)
- Previous identified allergy or hypersensitivity to any component of the study treatment
- Allergies to eggs, egg products, soybeans, or soy products
- Personal or first degree relative with a history of malignant hyperthermia
- Has a known additional malignancy that is expected to require active treatment within two years, or is likely to be life-limiting in the opinion of the treating investigator. Superficial bladder cancer, non-melanoma skin cancers, or low-grade prostate cancer not requiring therapy would not exclude participation in this trial.
- Uncontrolled intercurrent illness including, but not limited to: Symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anesthesia ProcedureAlso: AnesthesiaGiven TIVA | Procedure or surgery | Arm I (surgical resection with TIVA) |
| General Anesthesia ProcedureAlso: General AnesthesiaGiven inhaled volatile anesthetics | Drug | Arm II (surgical resection with inhaled volatile anesthetics) |
| ResectionAlso: Surgical ResectionUndergo surgical resection | Procedure or surgery | Arm I (surgical resection with TIVA), Arm II (surgical resection with inhaled volatile anesthetics) |
Primary outcome
Impact of Anesthetic Agent on Inflammation and Immunosuppression
Time frame: Up to 2 years
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.
1 secondary outcome
Impact of Anesthetic Choice on Short-term Anesthetic and Surgical Outcomes
Time frame: Up to 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- The JameslineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aslam Ejaz, MD principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anesthesia Procedure, General Anesthesia Procedure and Resection in people with Pancreatic Adenocarcinoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of Anesthetic Agent on Inflammation and Immunosuppression (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2025.