[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100366208":3},{"organization":4,"outcomesModule":7,"designInfo":26,"detailedDescription":37,"studyPopulation":25,"armGroups":38,"interventions":51,"overallOfficials":63,"centralContacts":68,"locations":75,"responsibleParty":111,"collaborators":25,"id":113,"slug":25,"hasResults":114,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":25,"eligibilityCriteria":118,"healthyVolunteers":114,"sex":119,"minAge":120,"maxAge":25,"enrollmentInfo":121,"targetDuration":25,"studyType":124,"phases":125,"briefSummary":127,"conditions":128,"keywords":130,"overallStatus":78,"whyStopped":25,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":146},{"fullName":5,"class":6},"University of Illinois at Chicago","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":20,"otherOutcomes":25},[9,13,15,17],{"measure":10,"description":11,"timeFrame":12},"Specimen outcome measure.","Src Tyrosine Kinase Enzymatic activity in CTCs. Fluorescence intensity will be used to measure Src phosphorylation in circulating tumor cells.","Outcomes will be evaluated perioperatively",{"measure":10,"description":14,"timeFrame":12},"Cytokine Levels in Serum (pg\u002Fml)",{"measure":10,"description":16,"timeFrame":12},"Chemokine levels in serum (pg\u002Fml)",{"measure":18,"description":19,"timeFrame":12},"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",[21],{"measure":22,"description":23,"timeFrame":24},"Specimen outcome measure","CTCs Enumeration","Perioperatively",null,{"allocation":27,"interventionModel":28,"interventionModelDescription":29,"primaryPurpose":30,"observationalModel":25,"timePerspective":25,"maskingInfo":31},"RANDOMIZED","PARALLEL","A prospective randomized placebo-controlled double blinded trial design will be used for the proposed study.","TREATMENT",{"masking":32,"maskingDescription":33,"whoMasked":34},"DOUBLE","Both patients and the physicians performing the cases will be unaware of who receives lidocaine or placebo.",[35,36],"PARTICIPANT","CARE_PROVIDER","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.\n\nA prospective randomized controlled double blinded trial design will be used for the proposed study.\n\nPatients 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.",[39,45],{"label":40,"type":41,"description":42,"interventionNames":43},"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\u002Fkg loading infusion over 5 minutes followed by a 1.0 - 1.5 mg\u002Fkg\u002Fh infusion for 24 h",[44],"Drug: Lidocaine Hydrochloride",{"label":46,"type":47,"description":48,"interventionNames":49},"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\u002Fkg\u002Fhr)",[50],"Drug: Saline Solution for Injection",[52,58],{"type":53,"name":40,"description":54,"armGroupLabels":55,"otherNames":56},"DRUG","IV Lidocaine a 1.0 - 1.5 mg\u002Fkg loading infusion for perioperative pain control",[40],[57],"Xylocaine",{"type":53,"name":46,"description":59,"armGroupLabels":60,"otherNames":61},"IV Saline a 1.0 - 1.5 mg\u002Fkg loading infusion for perioperative pain control",[46],[62],"Sodium Chloride",[64],{"name":65,"affiliation":66,"role":67},"Gina E. Votta-Velis, MD PhD","Associate Professor","PRINCIPAL_INVESTIGATOR",[69,74],{"name":70,"role":71,"phone":72,"phoneExt":25,"email":73},"Alexandra Barabanova, MS","CONTACT","(312)996-4020","barabano@uic.edu",{"name":65,"role":71,"phone":72,"phoneExt":25,"email":73},[76],{"facility":77,"status":78,"city":79,"state":80,"zip":81,"country":82,"countryCode":83,"cosmosGeoPoint":84,"geoPoint":89,"contacts":90},"University of Illnois at Chicago","RECRUITING","Chicago","Illinois","60612","United States","US",{"type":85,"coordinates":86},"Point",[87,88],-87.65005,41.85003,{"lat":88,"lon":87},[91,94,96,98,101,103,105,107,109],{"name":92,"role":71,"phone":72,"phoneExt":25,"email":93},"Gina E Votta-Velis, MD PhD","ginavot@uic.edu",{"name":70,"role":71,"phone":95,"phoneExt":25,"email":73},"(312)355-5733",{"name":97,"role":67,"phone":25,"phoneExt":25,"email":25},"E. Gina Votta-Velis, MD PhD",{"name":99,"role":100,"phone":25,"phoneExt":25,"email":25},"Ajay Rana, PhD","SUB_INVESTIGATOR",{"name":102,"role":100,"phone":25,"phoneExt":25,"email":25},"Pier C. Giulianotti, MD",{"name":104,"role":100,"phone":25,"phoneExt":25,"email":25},"Alain A. Borgeat, MD",{"name":106,"role":100,"phone":25,"phoneExt":25,"email":25},"Sandeep Kumar, PhD",{"name":108,"role":100,"phone":25,"phoneExt":25,"email":25},"Antonio Gangemi, MD",{"name":110,"role":100,"phone":25,"phoneExt":25,"email":25},"Valentina Valle, MD",{"type":67,"investigatorFullName":112,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Effrossyni Votta-Velis","100366208",false,"NCT04048278","Lidocaine Infusion in Pancreatic Cancer","Lidocaine Infusion in Pancreatic Cancer: Translational Studies in a Preclinical Model And Human Subjects","Inclusion Criteria:\n\n1. 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)\n2. Has measurable disease, defined as at least 1 tumor that fulfills the criteria\n3. Patients diagnosed with resectable cancer, but upon initial phase of surgical exploration found to have metastatic disease\n4. Has read, understood and signed the informed consent form (ICF) approved by the Independent Review Board\u002FIndependent Ethics Committee (IRB\u002FIEC)\n5. Prior systemic treatments for metastatic disease are permitted, including targeted therapies, biologic response modifiers, chemotherapy, hormonal therapy, or investigational therapy.\n\nExclusion Criteria:\n\n1. Has American Society of Anesthesiologists (ASA) physical status \\> 3\n2. Has hypersensitivity or allergy to amide-linked local anesthetics\n3. Has a second or third degree heart block\n4. Has severe sinoatrial block\n5. Is currently being treated with any of the following class I antiarrhythmic drugs; quinidine, flecainide, disopyramide, or procainamide\n6. Has been treated with amiodarone in the past\n7. Has Adams-Stoke syndrome\n8. Has Wolff-Parkinson-White syndrome\n9. Has a history of blood clots, pulmonary embolism, or deep vein thrombosis unless controlled by anticoagulant treatment\n10. Has a known history of human immunodeficiency virus (HIV) positivity or untreated and uncontrolled hepatitis B or C","ALL","18 Years",{"count":122,"type":123},46,"ESTIMATED","INTERVENTIONAL",[126],"EARLY_PHASE1","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.\n\nA prospective randomized controlled double blinded trial design will be used for the proposed study.",[129],"Pancreatic Cancer",[131,129,132,133,134,135,136],"Pancreas","Lidocaine","Enzymatic Activity","Cytokines","Chemokines","Gene Expression","2026-06-11",{"date":139,"type":140},"2026-06-15","ACTUAL",{"date":142,"type":140},"2018-11-08",{"date":144,"type":123},"2028-01-01",{"name":5,"class":6},1]