Ignite Creation Date:
2025-12-24 @ 5:41 PM
Ignite Modification Date:
2026-01-03 @ 11:10 PM
Study NCT ID:
NCT06162468
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-23
First Post:
2023-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility Trial of EUS-PCA in IPMN Pancreatic Cysts
Sponsor:
University of Auckland, New Zealand
Organization:
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: