Feasibility Trial of EUS-PCA in IPMN Pancreatic Cysts

Prior treatment

• 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.

Other illness

• 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.

Lab values

• 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

Other

• Evidence of pancreatitis within the last 6 months.
• Pregnancy, lactation, or inadequate contraception.

• 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.