Clinical trial · Interventional
Feasibility Trial of EUS-PCA in IPMN Pancreatic Cysts
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
NCT06162468CI-TRIAL-00088803not yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Intraductal Papillary Mucinous Neoplasm of Pancreas | Pancreatic Intraductal Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endoscopic ultrasound-guided pancreatic cyst chemoablation (EUS-PCA) using gemcitabine and paclitaxel | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single-arm
- description
- Gemcitabine 19 mg per 1 ml of estimated cyst fluid + paclitaxel 3 mg per 1 ml of estimated cyst fluid + 0.9% sodium chloride solution, given as a single administration
- interventionNames
- Procedure: Endoscopic ultrasound-guided pancreatic cyst chemoablation (EUS-PCA) using gemcitabine and paclitaxel
Primary outcomes (1)
- measure
- The proportion of patients in whom EUS-PCA was completed as planned.
- timeFrame
- 2 years
- description
- The proportion of patients in whom the cyst was aspirated and injected with the chemotherapy solution as intended, determined by the interventional endoscopist.
Secondary outcomes (1)
- measure
- The IPMN complete response rate in the injected lesion(s) on imaging 3 months post-EUS-PCA.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.