Pancreatic Adenocarcinoma
Conditions
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 2 years.
Interventions
PROCEDUREAnesthesia Procedure
Given TIVA
DRUGGeneral Anesthesia Procedure
Given inhaled volatile anesthetics
PROCEDUREResection
Undergo surgical resection
Sponsors
Ohio State University Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Impact of Anesthetic Agent on Inflammation and Immunosuppression | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Impact of Anesthetic Choice on Short-term Anesthetic and Surgical Outcomes | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm I (Surgical Resection With TIVA) Patients undergo surgical resection with TIVA.
Anesthesia Procedure: Given TIVA
Resection: Undergo surgical resection | 5 |
| Arm II (Surgical Resection With Inhaled Volatile Anesthetics) Patients undergo surgical resection with inhaled volatile anesthetics.
General Anesthesia Procedure: Given inhaled volatile anesthetics
Resection: Undergo surgical resection | 3 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 1 |
| Overall Study | Study terminated early due to principal investigator departing sponsoring organization | 5 | 2 |
Baseline characteristics
| Characteristic | Arm I (Surgical Resection With TIVA) | Arm II (Surgical Resection With Inhaled Volatile Anesthetics) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 2 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 1 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 3 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 3 Participants | 8 Participants |
| Region of Enrollment United States | 5 participants | 3 participants | 8 participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Male | 4 Participants | 2 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 1 / 3 |
| other Total, other adverse events | 3 / 5 | 2 / 3 |
| serious Total, serious adverse events | 0 / 5 | 0 / 3 |
Outcome results
Primary
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.
Time frame: Up to 2 years
Population: Due to the early termination of the study, only one participant underwent surgery and received treatment and that participant did not stay on study long enough to have data collected for the primary or secondary outcome measure. Therefore, there is no collected data to report for this outcome measure.
Secondary
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.
Time frame: Up to 2 years
Population: Due to the early termination of the study, only one participant underwent surgery and received treatment and that participant did not stay on study long enough to have data collected for the primary or secondary outcome measure. Therefore, there is no collected data to report for this outcome measure.