Feasibility Trial of EUS-PCA in IPMN Pancreatic Cysts
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Auckland, New Zealand
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Presence of known or suspected pancreatic cancer or pathologic lymphadenopathy.
Main pancreatic duct dilation of >10 mm
Cytology with high grade dysplasia or "suspicious for malignancy"
Common bile duct obstruction causing jaundice
Trial design
Design model
Single group
Treatments tested in this trial
Endoscopic ultrasound-guided pancreatic cyst chemoablation (EUS-PCA) using gemcitabine and paclitaxel
Procedure/SurgeryEUS-PCA using gemcitabine and paclitaxel
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Single-armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The proportion of patients in whom EUS-PCA was completed as planned.
The proportion of patients in whom the cyst was aspirated and injected with the chemotherapy solution as intended, determined by the interventional endoscopist.
Time frame
2 yearsSecondary outcomes
1
The IPMN complete response rate in the injected lesion(s) on imaging 3 months post-EUS-PCA.
The proportion with a complete response (CR) in the injected lesion on imaging 3 months after EUS-PCA a) in all recruited patients, and b) in those in whom EUS-PCA was successfully completed. * The proportion with CR at 3 months in Māori and non-Māori. * The safety of EUS-PCA in the first 30 days post-procedure. * The additional resource use required for this procedure compared to EUS and cyst aspiration alone. * Cyst characteristics according to radiological features and amylase, CEA, viscosity, and cytology from cyst fluid.
Time frame
2 yearsSponsors and contacts
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University of Auckland, New Zealand
Lead sponsor
Gut Cancer Foundation, New Zealand
Collaborator
North Shore Hospital, New Zealand
Collaborator
Waikato Hospital
Collaborator
Source ClinicalTrials.gov
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