A Clinical Study of EUS-RFA for Inoperable Pancreatic Ductal Adenocarcinoma (EUS-RFA)
A Phase II Prospective Randomised Clinical Study of Endoscopic Ultrasound Guided Radiofrequency Ablation (EUS-RFA) for Inoperable Pancreatic Ductal Adenocarcinoma
Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Suspended
There was a voluntary recall from the Habib EUS RFA device manufacturer
This observational or N/A phase trial investigates Pancreatic Ductal Adenocarcinoma and is currently suspended. Centre hospitalier de l'Université de Montréal (CHUM) leads this study, which shows 13 recorded versions since 2019 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.
Study Description(click to expand)The five-year survival for pancreatic ductal adenocarcinoma (PDAC) is less than 5% in spite of the advances in management of cancers in the last few decades. Endobiliary application of radiofrequency (RF) has been developed and used in patients with inoperable bile duct and pancreatic head adenocarcinomas presenting with biliary obstruction. (1, 2) Endoscopic ultrasound (EUS) radiofrequency ablation (RFA) of pancreatic neoplasms has been proven to be well tolerated and safe, inducing a significant reduction in tumour size (3). Various techniques of EUS-guided tumour ablation have been described, including RF ablation, photodynamic therapy, laser ablation, and ethanol injection (4). Kahaleh et al. have demonstrated that Endoscopic ultrasound guided RF ablation (EUS-RFA) of the pancreatic head using Habib EUS-RFA catheter (EMcision Ltd, UK) through a 19-gauge needle was well tolerated in 5 Yucatan pigs and with minimum amount of pancreatitis (5). In a pilot clinical study, Pai et al showed either a complete response or at least a 50% reduction in tumours following application of radiofrequency ablation with the Habib™ EUS-RFA device in a group of eight patients with pancreatic cancers (3).
The five-year survival for pancreatic ductal adenocarcinoma (PDAC) is less than 5% in spite of the advances in management of cancers in the last few decades. Endobiliary application of radiofrequency (RF) has been developed and used in patients with inoperable bile duct and pancreatic head adenocarcinomas presenting with biliary obstruction. (1, 2) Endoscopic ultrasound (EUS) radiofrequency ablation (RFA) of pancreatic neoplasms has been proven to be well tolerated and safe, inducing a significant reduction in tumour size (3). Various techniques of EUS-guided tumour ablation have been described, including RF ablation, photodynamic therapy, laser ablation, and ethanol injection (4). Kahaleh et al. have demonstrated that Endoscopic ultrasound guided RF ablation (EUS-RFA) of the pancreatic head using Habib EUS-RFA catheter (EMcision Ltd, UK) through a 19-gauge needle was well tolerated in 5 Yucatan pigs and with minimum amount of pancreatitis (5). In a pilot clinical study, Pai et al showed either a complete response or at least a 50% reduction in tumours following application of radiofrequency ablation with the Habib™ EUS-RFA device in a group of eight patients with pancreatic cancers (3).
Status Flow
Change History
13 versions recorded-
Apr 28, 2026 — Present [daily]
Suspended
Phase: NA → None
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Sep 2025 — Apr 2026 [monthly]
Suspended NA
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Sep 2024 — Sep 2025 [monthly]
Suspended NA
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Jul 2024 — Sep 2024 [monthly]
Suspended NA
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Nov 2023 — Jul 2024 [monthly]
Suspended NA
▶ Show 8 earlier versions
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Nov 2022 — Nov 2023 [monthly]
Suspended NA
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Sep 2021 — Nov 2022 [monthly]
Suspended NA
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Jan 2021 — Sep 2021 [monthly]
Suspended NA
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Jun 2020 — Jan 2021 [monthly]
Suspended NA
Phase: PHASE2 → NA
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May 2020 — Jun 2020 [monthly]
Suspended PHASE2
Status: Active Not Recruiting → Suspended
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Mar 2019 — May 2020 [monthly]
Active Not Recruiting PHASE2
Status: Not Yet Recruiting → Active Not Recruiting
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Jun 2018 — Mar 2019 [monthly]
Not Yet Recruiting PHASE2
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Mar 2018 — Jun 2018 [monthly]
Not Yet Recruiting PHASE2
First recorded
Eligibility Summary
To assess if endoscopic ultrasound-guided radiofrequency ablation application in patients with inoperable pancreatic cancer confers survival benefit when compared to patients receiving standard medical care.
Contact Information
- Centre hospitalier de l'Université de Montréal (CHUM)
For direct contact, visit the study record on ClinicalTrials.gov .