Status:
NOT_YET_RECRUITING
Feasibility Trial of EUS-PCA in IPMN Pancreatic Cysts
Lead Sponsor:
University of Auckland, New Zealand
Collaborating Sponsors:
Gut Cancer Foundation, New Zealand
North Shore Hospital, New Zealand
Conditions:
Intraductal Papillary Mucinous Neoplasm of Pancreas
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
Detailed Description
Early detection and treatment of pancreatic premalignant lesions, most commonly IPMN, may be the best current strategy to prevent invasive pancreatic cancer. The rates of IPMN progression to invasive ...
Eligibility Criteria
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
- Presence of known or suspected pancreatic cancer or pathologic lymphadenopathy.
- 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
- 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.
- History of hypersensitivity to gemcitabine or paclitaxel.
- Concurrent illness that may jeopardise the ability of the patient to safely undergo the procedures outlined in this protocol.
- 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.
- Pregnancy, lactation, or inadequate contraception.
Key Trial Info
Start Date :
May 31 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06162468
Start Date
May 31 2025
End Date
July 31 2026
Last Update
April 23 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Te Whatu Ora Waitematā
Auckland, New Zealand
2
Te Whatu Ora Waikato
Hamilton, New Zealand