NCT06162468

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 Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
3mo left

Started May 2025

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress80%
May 2025Jul 2026

First Submitted

Initial submission to the registry

November 20, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

December 8, 2023

Completed
1.5 years until next milestone

Study Start

First participant enrolled

May 31, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Last Updated

April 23, 2025

Status Verified

April 1, 2025

Enrollment Period

1.1 years

First QC Date

November 20, 2023

Last Update Submit

April 21, 2025

Conditions

Intraductal Papillary Mucinous Neoplasm of Pancreas

Outcome Measures

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.

    2 years

Secondary Outcomes (1)

  • The IPMN complete response rate in the injected lesion(s) on imaging 3 months post-EUS-PCA.

    2 years

Study Arms (1)

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

Procedure: Endoscopic ultrasound-guided pancreatic cyst chemoablation (EUS-PCA) using gemcitabine and paclitaxel

Interventions

Endoscopic ultrasound-guided pancreatic cyst chemoablation (EUS-PCA) using gemcitabine and paclitaxelPROCEDURE

EUS-PCA using gemcitabine and paclitaxel

Single-arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Te Whatu Ora Waitematā

Auckland, New Zealand

Location

Te Whatu Ora Waikato

Hamilton, New Zealand

Location

MeSH Terms

Conditions

Pancreatic Intraductal Neoplasms

Interventions

Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms, Ductal, Lobular, and MedullaryNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsPancreatic NeoplasmsDigestive System NeoplasmsNeoplasms by SiteEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Michael B Jameson, PhD

    University of Auckland, New Zealand

    STUDY CHAIR

Central Study Contacts

Eibhlin Corrigan

CONTACT

+64 (0)9 923 9643eibhlin.corrigan@auckland.ac.nz

Sarah Benge

CONTACT

+64276045647s.benge@auckland.ac.nz

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 20, 2023

First Posted

December 8, 2023

Study Start

May 31, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

July 31, 2026

Last Updated

April 23, 2025

Record last verified: 2025-04

Locations

NZ(2)