Feasibility Trial of EUS-PCA in IPMN Pancreatic Cysts

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 intraductal papillary mucinous neoplasms (IPMN) in two New Zealand tertiary interventional endoscopy centres.

Interventions

• Endoscopic ultrasound-guided pancreatic cyst chemoablation (EUS-PCA) using gemcitabine and paclitaxel · PROCEDURE

  EUS-PCA using gemcitabine and paclitaxel

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

Inclusion Criteria:

* 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 Criteria:

* Presence of known or suspected pancreatic cancer or pathologic lymphadenopathy.
* Radiological diagnosis of IPMN with any of the following:

  1. Main pancreatic duct dilation of \>10 mm
  2. Cytology with high grade dysplasia or "suspicious for malignancy"
  3. Common bile duct obstruction causing jaundice
  4. Septated cysts with \> 4 compartments
  5. Epithelial type mural nodules (\> 2mm)
  6. Lesions with thick wall/septation (\> 2mm)
  7. High-grade communication with the main pancreatic duct
  8. Previous aspiration failure due to excessive cyst fluid viscosity
* Clinically significant laboratory abnormalities

  1. INR \>= 1.7
  2. APTT \> 80 secs
  3. Platelet count \< 100 x 10E9/L
  4. ALT \> 500 U/L
  5. 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.

Sites (2)

• Te Whatu Ora Waitematā, Auckland, New Zealand
• Te Whatu Ora Waikato, Hamilton, New Zealand