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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06162468




Registration number
NCT06162468
Ethics application status
Date submitted
20/11/2023
Date registered
8/12/2023
Date last updated
8/05/2024

Titles & IDs
Public title
Feasibility Trial of EUS-PCA in IPMN Pancreatic Cysts
Scientific 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
Secondary ID [1] 0 0
CTNZ-2022-06
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intraductal Papillary Mucinous Neoplasm of Pancreas 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Skin 0 0 0 0
Other skin conditions
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Cancer 0 0 0 0
Pancreatic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Endoscopic ultrasound-guided pancreatic cyst chemoablation (EUS-PCA) using gemcitabine and paclitaxel

Experimental: Single-arm - 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


Treatment: Surgery: Endoscopic ultrasound-guided pancreatic cyst chemoablation (EUS-PCA) using gemcitabine and paclitaxel
EUS-PCA using gemcitabine and paclitaxel
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The proportion of patients in whom EUS-PCA was completed as planned.
Timepoint [1] 0 0
2 years
Secondary outcome [1] 0 0
The IPMN complete response rate in the injected lesion(s) on imaging 3 months post-EUS-PCA.
Timepoint [1] 0 0
2 years

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/06/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/08/2025
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Hamilton

Funding & Sponsors
Primary sponsor type
Other
Name
University of Auckland, New Zealand
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Gut Cancer Foundation, New Zealand
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
North Shore Hospital, New Zealand
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Waikato Hospital
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT06162468
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael B Jameson, PhD
Address 0 0
University of Auckland, New Zealand
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Eibhlin Corrigan
Address 0 0
Country 0 0
Phone 0 0
+64 (0)9 923 9643
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06162468