[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100528568":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":35,"responsibleParty":58,"collaborators":62,"id":70,"slug":20,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":20,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":20,"enrollmentInfo":78,"targetDuration":20,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":20,"overallStatus":87,"whyStopped":20,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"University of Auckland, New Zealand","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Single-arm","EXPERIMENTAL","Gemcitabine 19 mg per 1 ml of estimated cyst fluid + paclitaxel 3 mg per 1 ml of estimated cyst fluid + 0.9% sodium chloride solution, given as a single administration",[13],"Procedure: Endoscopic ultrasound-guided pancreatic cyst chemoablation (EUS-PCA) using gemcitabine and paclitaxel",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"PROCEDURE","Endoscopic ultrasound-guided pancreatic cyst chemoablation (EUS-PCA) using gemcitabine and paclitaxel","EUS-PCA using gemcitabine and paclitaxel",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Michael B Jameson, PhD","STUDY_CHAIR",[26,31],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":30},"Eibhlin Corrigan","CONTACT","+64 (0)9 923 9643","eibhlin.corrigan@auckland.ac.nz",{"name":32,"role":28,"phone":33,"phoneExt":20,"email":34},"Sarah Benge","+64276045647","s.benge@auckland.ac.nz",[36,48],{"facility":37,"status":20,"city":38,"state":20,"zip":20,"country":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Te Whatu Ora Waitematā","Auckland","New Zealand",{"type":41,"coordinates":42},"Point",[43,44],174.76349,-36.84853,{"lat":44,"lon":43},[47],{"name":27,"role":28,"phone":20,"phoneExt":20,"email":30},{"facility":49,"status":20,"city":50,"state":20,"zip":20,"country":39,"cosmosGeoPoint":51,"geoPoint":55,"contacts":56},"Te Whatu Ora Waikato","Hamilton",{"type":41,"coordinates":52},[53,54],175.28333,-37.78333,{"lat":54,"lon":53},[57],{"name":27,"role":28,"phone":20,"phoneExt":20,"email":30},{"type":59,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Michael Jameson","Associate Professor",[63,66,68],{"name":64,"class":65},"Gut Cancer Foundation, New Zealand","UNKNOWN",{"name":67,"class":6},"North Shore Hospital, New Zealand",{"name":69,"class":6},"Waikato Hospital","100528568",false,"NCT06162468","Feasibility Trial of EUS-PCA in IPMN Pancreatic Cysts","Single-arm Intervention Trial of the Feasibility of Endoscopic Ultrasound-guided Pancreatic Cyst Chemoablation (EUS-PCA) Using Gemcitabine and Paclitaxel for Intraductal Papillary Mucinous Neoplasms (IPMN) in Two New Zealand Tertiary Interventional Endoscopy Centres","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Radiological diagnosis of branch duct IPMN.\n* Cyst size of 3cm or worrying growth on serial imaging.\n* Suitable to undergo endoscopy under deep sedation or general anaesthesia.\n* Willing and able to comply with all trial requirements, including treatment, timing and\u002For nature of required assessments.\n* Signed, written informed consent.\n\nExclusion Criteria:\n\n* Presence of known or suspected pancreatic cancer or pathologic lymphadenopathy.\n* Radiological diagnosis of IPMN with any of the following:\n\n  1. Main pancreatic duct dilation of \\>10 mm\n  2. Cytology with high grade dysplasia or \"suspicious for malignancy\"\n  3. Common bile duct obstruction causing jaundice\n  4. Septated cysts with \\> 4 compartments\n  5. Epithelial type mural nodules (\\> 2mm)\n  6. Lesions with thick wall\u002Fseptation (\\> 2mm)\n  7. High-grade communication with the main pancreatic duct\n  8. Previous aspiration failure due to excessive cyst fluid viscosity\n* Clinically significant laboratory abnormalities\n\n  1. INR \\>= 1.7\n  2. APTT \\> 80 secs\n  3. Platelet count \\\u003C 100 x 10E9\u002FL\n  4. ALT \\> 500 U\u002FL\n  5. Total bilirubin \\> 25 umol\u002FL\n* Evidence of pancreatitis within the last 6 months.\n* History of hypersensitivity to gemcitabine or paclitaxel.\n* Concurrent illness that may jeopardise the ability of the patient to safely undergo the procedures outlined in this protocol.\n* Any medical condition that would, at the discretion of the investigator, interfere with the completion of and\u002For participation in the protocol.\n* Presence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the trial protocol and follow-up schedule, including alcohol dependence or drug abuse.\n* Pregnancy, lactation, or inadequate contraception.","ALL","18 Years",{"count":79,"type":80},20,"ESTIMATED","INTERVENTIONAL",[83],"NA","The goal of this single-arm intervention trial is to determine the feasibility of implementing endoscopic ultrasound-guided pancreatic cyst chemoablation (EUS-PCA) using gemcitabine and paclitaxel for intraductal papillary mucinous neoplasms (IPMN) in two New Zealand tertiary interventional endoscopy centres.",[86],"Intraductal Papillary Mucinous Neoplasm of Pancreas","NOT_YET_RECRUITING","2025-04-21",{"date":90,"type":91},"2025-04-23","ACTUAL",{"date":93,"type":80},"2025-05-31",{"date":95,"type":80},"2026-07-31",{"name":5,"class":6},2]