deltatrials
Suspended INTERVENTIONAL NCT03444948

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)

Updated 13 times since 2018 Last updated: Apr 20, 2026 Started: Feb 14, 2019 Primary completion: Jun 30, 2028 Completion: Dec 1, 2028
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

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

~Mar 2018 – ~Jun 2018 · 3 months · monthly snapshot~Jun 2018 – ~Mar 2019 · 9 months · monthly snapshot~Mar 2019 – ~May 2020 · 14 months · monthly snapshot~May 2020 – ~Jun 2020 · 31 days · monthly snapshot~Jun 2020 – ~Jan 2021 · 7 months · monthly snapshot~Jan 2021 – ~Sep 2021 · 8 months · monthly snapshot~Sep 2021 – ~Nov 2022 · 14 months · monthly snapshot~Nov 2022 – ~Nov 2023 · 12 months · monthly snapshot~Nov 2023 – ~Jul 2024 · 8 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – ~Apr 2026 · 8 months · monthly snapshotApr 28, 2026 – present · 2 months · daily API

Change History

13 versions recorded
  1. Apr 28, 2026 — Present [daily]

    Suspended

    Phase: NANone

  2. Sep 2025 — Apr 2026 [monthly]

    Suspended NA

  3. Sep 2024 — Sep 2025 [monthly]

    Suspended NA

  4. Jul 2024 — Sep 2024 [monthly]

    Suspended NA

  5. Nov 2023 — Jul 2024 [monthly]

    Suspended NA

Show 8 earlier versions
  1. Nov 2022 — Nov 2023 [monthly]

    Suspended NA

  2. Sep 2021 — Nov 2022 [monthly]

    Suspended NA

  3. Jan 2021 — Sep 2021 [monthly]

    Suspended NA

  4. Jun 2020 — Jan 2021 [monthly]

    Suspended NA

    Phase: PHASE2NA

  5. May 2020 — Jun 2020 [monthly]

    Suspended PHASE2

    Status: Active Not RecruitingSuspended

  6. Mar 2019 — May 2020 [monthly]

    Active Not Recruiting PHASE2

    Status: Not Yet RecruitingActive Not Recruiting

  7. Jun 2018 — Mar 2019 [monthly]

    Not Yet Recruiting PHASE2

  8. 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

Sponsor contact:
  • Centre hospitalier de l'Université de Montréal (CHUM)
Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations