Intraductal Papillary Mucinous Neoplasm of PancreasNCT06162468
Feasibility Trial of EUS-PCA in IPMN Pancreatic Cysts
A study testing Endoscopic ultrasound-guided pancreatic cyst chemoablation (EUS-PCA) using gemcitabine and paclitaxel in people with Intraductal Papillary Mucinous Neoplasm of Pancreas, run by University of Auckland, New Zealand at 2 sites in New Zealand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intraductal Papillary Mucinous Neoplasm of Pancreas
- What is being tested?
- Endoscopic ultrasound-guided pancreatic cyst chemoablation (EUS-PCA) using gemcitabine and paclitaxel
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesNew Zealand
- Study dates
- 31 May 2025to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 22Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
New Zealand2 sites
Te Whatu Ora Waitematā
Auckland
Eibhlin Corrigan, eibhlin.corrigan@auckland.ac.nz
Te Whatu Ora Waikato
Hamilton
Eibhlin Corrigan, eibhlin.corrigan@auckland.ac.nz
About this study
Official title: 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
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.
Read the 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 cancer range from 7 to 25% at 10 years, depending on risk characteristics. The feasibility and safety of EUS-PCA has been demonstrated in studies, including smaller randomised trials, totaling about 140 participants. EUS-PCA with the chemotherapy drugs being used in this trial has been implemented in several major international centres due to its potential for the minimally-invasive prevention of invasive pancreatic cancer, though it has never been compared to surgery in a clinical trial.
This single-arm intervention trial will evaluate the feasibility of implementing endoscopic ultrasound-guided pancreatic cyst ablation (EUS-PCA) for IPMN in interventional endoscopy units in two New Zealand tertiary centres. Doing so in a clinical trial is consistent with the recommendation of an international expert panel to implement EUS-PCA in the context of a research trial.
A previous US trial reported a complete response rate at 12 months of 59%, with response maintained or further improved at 3 years. Of those with complete response, >95% of patients had not relapsed a median of 6 years after EUS-PCA. About 8% of patients in this trial underwent surgery for persistent cysts.
The trial will recruit patients with concerning IPMN features, for whom a multidisciplinary meeting recommends EUS-PCA as a treatment option. This patient group would usually be recommended to have surgery, but many patients decline surgery due to its high morbidity and significant mortality rates or are not candidates for this due to comorbidities or other issues. If EUS-PCA is successful, then it may ablate these precancerous lesions, treat patients who are not fit for surgery and reduce the incidence of invasive pancreatic adenocarcinoma. This is likely to reduce inequity for Māori, who are at higher risk of being ineligible for surgery for these lesions. While this is a small trial, we will also aim to recruit 50% Māori to further address inequity of opportunity and health outcomes.
- Being tested
- Endoscopic ultrasound-guided pancreatic cyst chemoablation (EUS-PCA) using gemcitabine and paclitaxel
- Medical subject headings
- Pancreatic Intraductal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic ultrasound-guided pancreatic cyst chemoablation (EUS-PCA) using gemcitabine and paclitaxelProcedure or surgery
EUS-PCA using gemcitabine and paclitaxel
| Study group | Role | What they receive |
|---|---|---|
| Single-arm | Experimental | 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 Receives: Procedure: Endoscopic ultrasound-guided pancreatic cyst chemoablation (EUS-PCA) using gemcitabine and paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start31 May 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraductal Papillary Mucinous Neoplasm of PancreasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A single-arm 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.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Auckland, New Zealand
- Sponsor type
- University, hospital or other
- Collaborators
- Gut Cancer Foundation, New Zealand, North Shore Hospital, New Zealand, Waikato Hospital
- Responsible party
- Principal investigator, Michael Jameson, University of Auckland, New Zealand
- Investigators
- Michael B Jameson, PhD, Study chair, University of Auckland, New Zealand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06162468
- Sponsor's protocol ID
- CTNZ-2022-06
- Status last verified
- Apr 2025
- First submitted
- 20 Nov 2023
- Last updated
- 23 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06162468
- Acronym / sponsor ID
- CTNZ-2022-06
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Auckland, New ZealandUniversity, hospital or other
- Collaborators
- Gut Cancer Foundation, New Zealand, North Shore Hospital, New Zealand, Waikato Hospital
- Study start
- 31 May 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 8 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 cancer range from 7 to 25% at 10 years, depending on risk characteristics. The feasibility and safety of EUS-PCA has been demonstrated in studies, including smaller randomised trials, totaling about 140 participants. EUS-PCA with the chemotherapy drugs being used in this trial has been implemented in several major international centres due to its potential for the minimally-invasive prevention of invasive pancreatic cancer, though it has never been compared to surgery in a clinical trial.
This single-arm intervention trial will evaluate the feasibility of implementing endoscopic ultrasound-guided pancreatic cyst ablation (EUS-PCA) for IPMN in interventional endoscopy units in two New Zealand tertiary centres. Doing so in a clinical trial is consistent with the recommendation of an international expert panel to implement EUS-PCA in the context of a research trial.
A previous US trial reported a complete response rate at 12 months of 59%, with response maintained or further improved at 3 years. Of those with complete response, >95% of patients had not relapsed a median of 6 years after EUS-PCA. About 8% of patients in this trial underwent surgery for persistent cysts.
The trial will recruit patients with concerning IPMN features, for whom a multidisciplinary meeting recommends EUS-PCA as a treatment option. This patient group would usually be recommended to have surgery, but many patients decline surgery due to its high morbidity and significant mortality rates or are not candidates for this due to comorbidities or other issues. If EUS-PCA is successful, then it may ablate these precancerous lesions, treat patients who are not fit for surgery and reduce the incidence of invasive pancreatic adenocarcinoma. This is likely to reduce inequity for Māori, who are at higher risk of being ineligible for surgery for these lesions. While this is a small trial, we will also aim to recruit 50% Māori to further address inequity of opportunity and health outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single-arm 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.
| Arm | Type | Receives |
|---|---|---|
| Single-arm | Experimental | Procedure: Endoscopic ultrasound-guided pancreatic cyst chemoablation (EUS-PCA) using gemcitabine and paclitaxelGemcitabine 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (22 listed)
- Presence of known or suspected pancreatic cancer or pathologic lymphadenopathy.
- Radiological diagnosis of IPMN with any of the following:
- Clinically significant laboratory abnormalities
- Evidence of pancreatitis within the last 6 months.
- History of hypersensitivity to gemcitabine or paclitaxel.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic ultrasound-guided pancreatic cyst chemoablation (EUS-PCA) using gemcitabine and paclitaxelEUS-PCA using gemcitabine and paclitaxel | Procedure or surgery | Single-arm |
Primary outcome
The proportion of patients in whom EUS-PCA was completed as planned.
Time frame: 2 years
The proportion of patients in whom the cyst was aspirated and injected with the chemotherapy solution as intended, determined by the interventional endoscopist.
1 secondary outcome
The IPMN complete response rate in the injected lesion(s) on imaging 3 months post-EUS-PCA.
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael B Jameson, PhD study chair
University of Auckland, New Zealand
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic ultrasound-guided pancreatic cyst chemoablation (EUS-PCA) using gemcitabine and paclitaxel in people with Intraductal Papillary Mucinous Neoplasm of Pancreas, run by University of Auckland, New Zealand at 2 sites in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eibhlin Corrigan (+64 (0)9 923 9643, eibhlin.corrigan@auckland.ac.nz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients in whom EUS-PCA was completed as planned. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2025.