Pancreatic CancerEarly Phase 1NCT04048278
Lidocaine Infusion in Pancreatic Cancer
A Early Phase 1 study testing Lidocaine Hydrochloride and Saline Solution for Injection in people with Pancreatic Cancer, run by University of Illinois Chicago at 1 site in United States.
Trial summary
This study elucidates the effects of the intravenous (IV) lidocaine infusion on the biology of pancreatic circulating tumor cells (CTCs) isolated from patients undergoing robotic pancreatectomy for all types of pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Lidocaine Hydrochloride and Saline Solution for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2018to 1 Jan 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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
- Has histologically or cytologically confirmed adenocarcinoma of the pancreas that is considered resectable as well as other types of pancreatic cancer (malignant endocrine and exocrine tumors)
- Has measurable disease, defined as at least 1 tumor that fulfills the criteria
- Patients diagnosed with resectable cancer, but upon initial phase of surgical exploration found to have metastatic disease
- Has read, understood and signed the informed consent form (ICF) approved by the Independent Review Board/Independent Ethics Committee (IRB/IEC)
- Prior systemic treatments for metastatic disease are permitted, including targeted therapies, biologic response modifiers, chemotherapy, hormonal therapy, or investigational therapy.
Who cannot join
- Has American Society of Anesthesiologists (ASA) physical status > 3
- Has hypersensitivity or allergy to amide-linked local anesthetics
- Has a second or third degree heart block
- Has severe sinoatrial block
- Is currently being treated with any of the following class I antiarrhythmic drugs; quinidine, flecainide, disopyramide, or procainamide
- Has been treated with amiodarone in the past
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- Has Adams-Stoke syndrome
- Has Wolff-Parkinson-White syndrome
- Has a history of blood clots, pulmonary embolism, or deep vein thrombosis unless controlled by anticoagulant treatment
- Has a known history of human immunodeficiency virus (HIV) positivity or untreated and uncontrolled hepatitis B or C
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Illnois at Chicago
Chicago, Illinois, 60612
Gina E Votta-Velis, MD PhD, (312)996-4020, ginavot@uic.edu
Alexandra Barabanova, MS, (312)355-5733, barabano@uic.edu
About this study
Official title: Lidocaine Infusion in Pancreatic Cancer: Translational Studies in a Preclinical Model And Human Subjects
This study elucidates the effects of the intravenous (IV) lidocaine infusion on the biology of pancreatic circulating tumor cells (CTCs) isolated from patients undergoing robotic pancreatectomy for all types of pancreatic cancer.
A prospective randomized controlled double blinded trial design will be used for the proposed study.
Read the detailed description
The primary objective of this study is to determine the effect of IV lidocaine infusion on various enzymatic activities and associated pathways in isolated CTCs as well as the number of CTCs during the perioperative period in patients undergoing robotic pancreatectomy for pancreatic cancer. It is expected that by downregulating the pathways by lidocaine might affect the enzymatic activity in those CTCs as well as the number of CTCs in the circulation.
A prospective randomized controlled double blinded trial design will be used for the proposed study.
Patients undergoing robotic pancreatectomy for pancreatic cancer will be randomized (ratio 1:1) into two groups: one group will receive a 24-h normal saline infusion and the second group will receive a 24-h lidocaine infusion. Blood samples will be collected in different times perioperatively in order to evaluate the objectives of the study.
- Conditions
- Pancreatic Cancer
- Being tested
- Lidocaine Hydrochloride, Saline Solution for Injection
- Keywords
- Pancreas, Pancreatic Cancer, Lidocaine, Enzymatic Activity, Cytokines, Chemokines, Gene Expression
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine HydrochlorideDrug
Also called Xylocaine
IV Lidocaine a 1.0 - 1.5 mg/kg loading infusion for perioperative pain control
Saline Solution for InjectionDrug
Also called Sodium Chloride
IV Saline a 1.0 - 1.5 mg/kg loading infusion for perioperative pain control
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine Hydrochloride | Experimental | The IV bolus and infusions of lidocaine to those patients assigned to the lidocaine group will be started in the operating room and will continue until 24 h later. The group receiving the lidocaine infusion will first be administered a 1.0 - 1.5 mg/kg loading infusion over 5 minutes followed by a 1.0 - 1.5 mg/kg/h infusion for 24 h Receives: Drug: Lidocaine Hydrochloride |
| Saline Solution for Injection | Placebo comparator | The group receiving the saline infusion will be administered an equivalent volume of saline infused over 5 min followed by a saline infusion at the same flow rate as that used in the lidocaine group for 24 h (1.0 - 1.5 mg/kg/hr) Receives: Drug: Saline Solution for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specimen outcome measure.
Src Tyrosine Kinase Enzymatic activity in CTCs. Fluorescence intensity will be used to measure Src phosphorylation in circulating tumor cells.
Measured: Outcomes will be evaluated perioperatively
Specimen outcome measure.
Cytokine Levels in Serum (pg/ml)
Measured: Outcomes will be evaluated perioperatively
Specimen outcome measure.
Chemokine levels in serum (pg/ml)
Measured: Outcomes will be evaluated perioperatively
Upregulation or Downregulation of Gene Expression.
Upregulation or downregulation of gene expression will be measured with the Real Time (RT) square Profiler Polimerase Chain Reaction (PCR )Array Analysis, and Real Time PCR
Measured: Outcomes will be evaluated perioperatively
Secondary outcomes (1)
Specimen outcome measure
CTCs Enumeration
Measured: Perioperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2019
- Study start8 Nov 2018
- Primary completion8 Nov 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective randomized placebo-controlled double blinded trial design will be used for the proposed study.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Effrossyni Votta-Velis, University of Illinois Chicago
- Investigators
- Gina E. Votta-Velis, MD PhD, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04048278
- Sponsor's protocol ID
- 2017-1365
- Status last verified
- Jun 2026
- First submitted
- 18 Jun 2019
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shakhar G, Ben-Eliyahu S. Potential prophylactic measures against postoperative immunosuppression: could they reduce recurrence rates in oncological patients? Ann Surg Oncol. 2003 Oct;10(8):972-92. doi: 10.1245/aso.2003.02.007.
PubMed 14527919Mokbel K, Choy C, Engledow A. The effect of surgical wounding on tumour development. Eur J Surg Oncol. 2000 Mar;26(2):195. doi: 10.1053/ejso.1999.0771. No abstract available.
PubMed 10744945Missair A, Cata JP, Votta-Velis G, Johnson M, Borgeat A, Tiouririne M, Gottumukkala V, Buggy D, Vallejo R, Marrero EB, Sessler D, Huntoon MA, Andres J, Casasola OL. Impact of perioperative pain management on cancer recurrence: an ASRA/ESRA special article. Reg Anesth Pain Med. 2019 Jan;44(1):13-28. doi: 10.1136/rapm-2018-000001.
PubMed 30640648Han L, Chen W, Zhao Q. Prognostic value of circulating tumor cells in patients with pancreatic cancer: a meta-analysis. Tumour Biol. 2014 Mar;35(3):2473-80. doi: 10.1007/s13277-013-1327-5. Epub 2013 Nov 12.
PubMed 24218336
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lidocaine Infusion in Pancreatic Cancer: Translational Studies in a Preclinical Model And Human Subjects
- ClinicalTrials.gov ID
- NCT04048278
- Acronym / sponsor ID
- 2017-1365
- Conditions
- Pancreatic Cancer
- Keywords
- Pancreas, Pancreatic Cancer, Lidocaine, Enzymatic Activity, Cytokines, Chemokines, Gene Expression
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- 8 Nov 2018 (actual)
- Primary completion
- 8 Nov 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 7 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study elucidates the effects of the intravenous (IV) lidocaine infusion on the biology of pancreatic circulating tumor cells (CTCs) isolated from patients undergoing robotic pancreatectomy for all types of pancreatic cancer.
A prospective randomized controlled double blinded trial design will be used for the proposed study.
Detailed description
The primary objective of this study is to determine the effect of IV lidocaine infusion on various enzymatic activities and associated pathways in isolated CTCs as well as the number of CTCs during the perioperative period in patients undergoing robotic pancreatectomy for pancreatic cancer. It is expected that by downregulating the pathways by lidocaine might affect the enzymatic activity in those CTCs as well as the number of CTCs in the circulation.
A prospective randomized controlled double blinded trial design will be used for the proposed study.
Patients undergoing robotic pancreatectomy for pancreatic cancer will be randomized (ratio 1:1) into two groups: one group will receive a 24-h normal saline infusion and the second group will receive a 24-h lidocaine infusion. Blood samples will be collected in different times perioperatively in order to evaluate the objectives of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- A prospective randomized placebo-controlled double blinded trial design will be used for the proposed study.
| Arm | Type | Receives |
|---|---|---|
| Lidocaine Hydrochloride | Experimental | Drug: Lidocaine HydrochlorideThe IV bolus and infusions of lidocaine to those patients assigned to the lidocaine group will be started in the operating room and will continue until 24 h later. The group receiving the lidocaine infusion will first be administered a 1.0 - 1.5 mg/kg loading infusion over 5 minutes followed by a 1.0 - 1.5 mg/kg/h infusion for 24 h |
| Saline Solution for Injection | Placebo comparator | Drug: Saline Solution for InjectionThe group receiving the saline infusion will be administered an equivalent volume of saline infused over 5 min followed by a saline infusion at the same flow rate as that used in the lidocaine group for 24 h (1.0 - 1.5 mg/kg/hr) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Has histologically or cytologically confirmed adenocarcinoma of the pancreas that is considered resectable as well as other types of pancreatic cancer (malignant endocrine and exocrine tumors)
- Has measurable disease, defined as at least 1 tumor that fulfills the criteria
- Patients diagnosed with resectable cancer, but upon initial phase of surgical exploration found to have metastatic disease
- Has read, understood and signed the informed consent form (ICF) approved by the Independent Review Board/Independent Ethics Committee (IRB/IEC)
- Prior systemic treatments for metastatic disease are permitted, including targeted therapies, biologic response modifiers, chemotherapy, hormonal therapy, or investigational therapy.
Key exclusion criteria (10 listed)
- Has American Society of Anesthesiologists (ASA) physical status > 3
- Has hypersensitivity or allergy to amide-linked local anesthetics
- Has a second or third degree heart block
- Has severe sinoatrial block
- Is currently being treated with any of the following class I antiarrhythmic drugs; quinidine, flecainide, disopyramide, or procainamide
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 |
|---|---|---|
| Lidocaine HydrochlorideAlso: XylocaineIV Lidocaine a 1.0 - 1.5 mg/kg loading infusion for perioperative pain control | Drug | Lidocaine Hydrochloride |
| Saline Solution for InjectionAlso: Sodium ChlorideIV Saline a 1.0 - 1.5 mg/kg loading infusion for perioperative pain control | Drug | Saline Solution for Injection |
Primary outcome
Specimen outcome measure.
Time frame: Outcomes will be evaluated perioperatively
Src Tyrosine Kinase Enzymatic activity in CTCs. Fluorescence intensity will be used to measure Src phosphorylation in circulating tumor cells.
Specimen outcome measure.
Time frame: Outcomes will be evaluated perioperatively
Cytokine Levels in Serum (pg/ml)
Specimen outcome measure.
Time frame: Outcomes will be evaluated perioperatively
Chemokine levels in serum (pg/ml)
Upregulation or Downregulation of Gene Expression.
Time frame: Outcomes will be evaluated perioperatively
Upregulation or downregulation of gene expression will be measured with the Real Time (RT) square Profiler Polimerase Chain Reaction (PCR )Array Analysis, and Real Time PCR
1 secondary outcome
Specimen outcome measure
Time frame: Perioperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Background: PubMed 14527919Shakhar G, Ben-Eliyahu S. Potential prophylactic measures against postoperative immunosuppression: could they reduce recurrence rates in oncological patients? Ann Surg Oncol. 2003 Oct;10(8):972-92. doi: 10.1245/aso.2003.02.007.
- Background: PubMed 10744945Mokbel K, Choy C, Engledow A. The effect of surgical wounding on tumour development. Eur J Surg Oncol. 2000 Mar;26(2):195. doi: 10.1053/ejso.1999.0771. No abstract available.
- Background: PubMed 30640648Missair A, Cata JP, Votta-Velis G, Johnson M, Borgeat A, Tiouririne M, Gottumukkala V, Buggy D, Vallejo R, Marrero EB, Sessler D, Huntoon MA, Andres J, Casasola OL. Impact of perioperative pain management on cancer recurrence: an ASRA/ESRA special article. Reg Anesth Pain Med. 2019 Jan;44(1):13-28. doi: 10.1136/rapm-2018-000001.
- Background: PubMed 24218336Han L, Chen W, Zhao Q. Prognostic value of circulating tumor cells in patients with pancreatic cancer: a meta-analysis. Tumour Biol. 2014 Mar;35(3):2473-80. doi: 10.1007/s13277-013-1327-5. Epub 2013 Nov 12.
- 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.
Gina E. Votta-Velis, MD PhD principal investigator
Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Lidocaine Hydrochloride and Saline Solution for Injection in people with Pancreatic Cancer, run by University of Illinois Chicago 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 5 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 15 Jun 2026. 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. Some participants in this study may receive a placebo. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexandra Barabanova, MS ((312)996-4020, barabano@uic.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Specimen outcome measure. (time frame: Outcomes will be evaluated perioperatively). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04048278, which also lists 4 linked publications.
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 15 Jun 2026.