Tests a chemotherapy injection into pancreatic cysts through endoscopy
Tests a drug-based cyst treatment in adults with pancreatic cysts called IPMN.
Plain-language title generated from the registry record
Registry title: Feasibility Trial of EUS-PCA in IPMN Pancreatic Cysts
Key facts
- Where
- Auckland and Hamilton, New ZealandSee the 2 sites
Where in New Zealand
- Te Whatu Ora WaitematāAuckland, New ZealandNo longer taking part
- Te Whatu Ora WaikatoHamilton, New ZealandNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Auckland, New Zealand
- Trial code
- NCT06162468
- Record updated
- 23 April 2025
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: Age ≥ 18 years; Radiological diagnosis of branch duct IPMN; Cyst size of 3cm or worrying growth on serial imaging; Suitable to undergo endoscopy under deep sedation or general anaesthesia; Willing and able to comply with all trial requirements, including treatment, timing and/or nature of required assessments; Signed, written informed consent.
Exclusion: Radiological diagnosis of IPMN with any of the following:; Main pancreatic duct dilation of >10 mm; Cytology with high grade dysplasia or "suspicious for malignancy"; Common bile duct obstruction causing jaundice; Septated cysts with > 4 compartments; Epithelial type mural nodules (> 2mm); Lesions with thick wall/septation (> 2mm); High-grade communication with the main pancreatic duct; Previous aspiration failure due to excessive cyst fluid viscosity; Concurrent illness that may jeopardise the ability of the patient to safely undergo the procedures outlined in this protocol; Presence of known or suspected pancreatic cancer or pathologic lymphadenopathy; History of hypersensitivity to gemcitabine or paclitaxel; Any medical condition that would, at the discretion of the investigator, interfere with the completion of and/or participation in the protocol; 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; Clinically significant laboratory abnormalities; INR >= 1.7; APTT > 80 secs; Platelet count < 100 x 10E9/L; ALT > 500 U/L; Total bilirubin > 25 umol/L; Evidence of pancreatitis within the last 6 months; Pregnancy, lactation, or inadequate contraception.