[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04048278":3,"trial-entities:NCT04048278":133,"trial-summary:NCT04048278":137},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":31,"interventions":34,"primary_outcomes":48,"secondary_outcomes":60,"sex":65,"minimum_age":66,"maximum_age":67,"healthy_volunteers":15,"eligibility_criteria":68,"std_ages":72,"locations":75,"central_contacts":111,"overall_officials":115,"references":118,"see_also_links":132},"NCT04048278","2017-1365","Lidocaine Infusion in Pancreatic Cancer","Lidocaine Infusion in Pancreatic Cancer: Translational Studies in a Preclinical Model And Human Subjects","RECRUITING","2028-01-01","2026-06","2026-06-15","2018-11-08","University of Illinois at Chicago","OTHER",false,"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.","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.",[19],"Pancreatic Cancer",[21,19,22,23,24,25,26],"Pancreas","Lidocaine","Enzymatic Activity","Cytokines","Chemokines","Gene Expression","INTERVENTIONAL","TREATMENT",[30],"EARLY_PHASE1",{"count":32,"type":33},46,"ESTIMATED",[35,42],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"DRUG","Lidocaine Hydrochloride","IV Lidocaine a 1.0 - 1.5 mg\u002Fkg loading infusion for perioperative pain control",[37],[41],"Xylocaine",{"type":36,"name":43,"description":44,"armGroupLabels":45,"otherNames":46},"Saline Solution for Injection","IV Saline a 1.0 - 1.5 mg\u002Fkg loading infusion for perioperative pain control",[43],[47],"Sodium Chloride",[49,53,55,57],{"measure":50,"description":51,"timeFrame":52},"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":50,"description":54,"timeFrame":52},"Cytokine Levels in Serum (pg\u002Fml)",{"measure":50,"description":56,"timeFrame":52},"Chemokine levels in serum (pg\u002Fml)",{"measure":58,"description":59,"timeFrame":52},"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",[61],{"measure":62,"description":63,"timeFrame":64},"Specimen outcome measure","CTCs Enumeration","Perioperatively","ALL","18 Years",null,{"inclusion":69,"exclusion":70,"raw_text":71},[],[],"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",[73,74],"ADULT","OLDER_ADULT",[76],{"facility":77,"status":8,"city":78,"state":79,"zip":80,"country":81,"contacts":82,"geoPoint":108},"University of Illnois at Chicago","Chicago","Illinois","60612","United States",[83,88,92,95,98,100,102,104,106],{"name":84,"role":85,"phone":86,"email":87},"Gina E Votta-Velis, MD PhD","CONTACT","(312)996-4020","ginavot@uic.edu",{"name":89,"role":85,"phone":90,"email":91},"Alexandra Barabanova, MS","(312)355-5733","barabano@uic.edu",{"name":93,"role":94},"E. Gina Votta-Velis, MD PhD","PRINCIPAL_INVESTIGATOR",{"name":96,"role":97},"Ajay Rana, PhD","SUB_INVESTIGATOR",{"name":99,"role":97},"Pier C. Giulianotti, MD",{"name":101,"role":97},"Alain A. Borgeat, MD",{"name":103,"role":97},"Sandeep Kumar, PhD",{"name":105,"role":97},"Antonio Gangemi, MD",{"name":107,"role":97},"Valentina Valle, MD",{"lat":109,"lon":110},41.85003,-87.65005,[112,113],{"name":89,"role":85,"phone":86,"email":91},{"name":114,"role":85,"phone":86,"email":91},"Gina E. Votta-Velis, MD PhD",[116],{"name":114,"affiliation":117,"role":94},"Associate Professor",[119,123,126,129],{"pmid":120,"type":121,"citation":122},"14527919","BACKGROUND","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\u002Faso.2003.02.007.",{"pmid":124,"type":121,"citation":125},"10744945","Mokbel 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\u002Fejso.1999.0771. No abstract available.",{"pmid":127,"type":121,"citation":128},"30640648","Missair 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\u002FESRA special article. Reg Anesth Pain Med. 2019 Jan;44(1):13-28. doi: 10.1136\u002Frapm-2018-000001.",{"pmid":130,"type":121,"citation":131},"24218336","Han 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\u002Fs13277-013-1327-5. Epub 2013 Nov 12.",[],{"nct_id":4,"conditions":134,"biomarkers":136},[135],"Pancreatic Carcinoma",[],{"nct_id":4,"found":138,"summary":139,"prompt_version":149},true,{"design":140,"status":141,"heading":142,"summary":143,"follow_up":144,"word_count":145,"commitments":146,"compensation":147,"drugs_mentioned":148},"This is a randomized, controlled, double-blinded study with a planned enrollment of 46 participants. Participants will be randomly assigned to one of two groups.","completed","Lidocaine Infusion for Pancreatic Cancer","This study is looking at how an intravenous (IV) infusion of Lidocaine Hydrochloride affects pancreatic cancer cells circulating in the blood (CTCs) during surgery. You might be eligible if you have pancreatic cancer that can be removed by surgery, including adenocarcinoma or other types of pancreatic cancer. Participants will receive either Lidocaine Hydrochloride or Saline Solution for Injection during their robotic pancreatectomy. Researchers will collect blood samples to see how these treatments affect the cancer cells. The goal is to understand if Lidocaine Hydrochloride can change the activity and number of these circulating cancer cells. The current status of this study is unclear.","Outcomes will be evaluated perioperatively (around the time of surgery).",103,"Participants will receive a 24-hour infusion of either Lidocaine Hydrochloride or Saline Solution for Injection during robotic pancreatectomy. Blood samples will be collected at different times around the surgery.","Not stated in the trial record.",[37,43],"v2"]