Pancreatic Ductal AdenocarcinomaEUS-RFANCT03444948
A Clinical Study of EUS-RFA for Inoperable Pancreatic Ductal Adenocarcinoma
A study testing EUS-RFA using Habib Tm as a probe and EUS in people with Pancreatic Ductal Adenocarcinoma, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma
- What is being tested?
- EUS-RFA using Habib Tm as a probe and EUS
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteCanada
- Study dates
- 14 Feb 2019to 1 Dec 2028
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients above 18 years of age.
- A cytological / histological diagnosis of inoperable PDAC based on multidisciplinary review of cross-sectional imaging and cytology / histology results.
- Patients ought to be fit enough to be considered for the study (ECOG (Eastern Cooperative Oncology Group) performance status 0, 1 or 2)
- Patients who have commenced chemotherapy are not excluded from the study
- Patients capable of giving informed consent
- Negative blood pregnancy test for women of childbearing potential
- Willingness and ability to comply with all protocol requirements including scheduled visits, treatment plans, laboratory tests and other study procedures.
Who cannot join
- ECOG performance status 3 or 4
- Life expectancy less than 3 months (including liver metastases, carcinomatosis)
- Prior investigational drugs within the last 30 days
- Known infection with human immunodeficiency virus (HIV)
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre de recherche du Centre hospitalier de l'université de Montréal
Montreal, Quebec, H2X 0A9
About this study
Official title: A Phase II Prospective Randomised Clinical Study of Endoscopic Ultrasound Guided Radiofrequency Ablation (EUS-RFA) for Inoperable Pancreatic Ductal Adenocarcinoma
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.
Read the detailed description
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).
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Being tested
- EUS-RFA using Habib Tm as a probe, EUS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUS-RFA using Habib Tm as a probeDevice
3 EUS-RFA interventions at 1-month interval
EUSProcedure or surgery
Standard intervention
| Study group | Role | What they receive |
|---|---|---|
| 3 radiofrequency ablation procedures | Experimental | Subject will undergo 3 radiofrequency ablation procedures at 1 month intervals (EUS-RFA using Habib Tm as a probe) Receives: Device: EUS-RFA using Habib Tm as a probe |
| standard medical care | Active comparator | Subject will receive standard medical care, including pain relief drugs Receives: Procedure: EUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Duration of survival
Measured: 1 month
Survival
Duration of survival
Measured: at time of death on average 10months
Secondary outcomes (6)
Quality of life (HEALTH, SOCIAL INTERACTIONS, DAILY ACTIVITIES)
Quality of life questionnaire DDQ15
Measured: 1 month
Quality of life (HEALTH, SOCIAL INTERACTIONS, DAILY ACTIVITIES)
Quality of life questionnaire DDQ15
Measured: Time of death on average 10 months
Pain reduction
Likert Scale
Measured: 1 month
Pain reduction
Likert Scale
Measured: Time of death on average 10months
Tumour Size
Measures during follow-up EUS
Measured: 4 months
Monitoring of Adverse reactions
Number of participants with treatment-related adverse events will be recorded
Measured: At time of death on average 10months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2018
- Study start14 Feb 2019
- Primary completion30 Jun 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Why it stopped: There was a voluntary recall from the Habib EUS RFA device manufacturer
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Ductal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ANAND V SAHAI, MD, Principal investigator, Centre de Recherche du Centre Hospitalier de l'Université de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03444948
- Sponsor's protocol ID
- CE 17.215
- Acronym
- EUS-RFA
- Status last verified
- Apr 2026
- First submitted
- 27 Oct 2017
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Prospective Randomised Clinical Study of Endoscopic Ultrasound Guided Radiofrequency Ablation (EUS-RFA) for Inoperable Pancreatic Ductal Adenocarcinoma
- ClinicalTrials.gov ID
- NCT03444948
- Acronym / sponsor ID
- EUS-RFA / CE 17.215
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: There was a voluntary recall from the Habib EUS RFA device manufacturer
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- 14 Feb 2019 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 26 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3 radiofrequency ablation procedures | Experimental | Device: EUS-RFA using Habib Tm as a probeSubject will undergo 3 radiofrequency ablation procedures at 1 month intervals (EUS-RFA using Habib Tm as a probe) |
| standard medical care | Active comparator | Procedure: EUSSubject will receive standard medical care, including pain relief drugs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients above 18 years of age.
- A cytological / histological diagnosis of inoperable PDAC based on multidisciplinary review of cross-sectional imaging and cytology / histology results.
- Patients ought to be fit enough to be considered for the study (ECOG (Eastern Cooperative Oncology Group) performance status 0, 1 or 2)
- Patients who have commenced chemotherapy are not excluded from the study
- Patients capable of giving informed consent
Key exclusion criteria (4 listed)
- ECOG performance status 3 or 4
- Life expectancy less than 3 months (including liver metastases, carcinomatosis)
- Prior investigational drugs within the last 30 days
- Known infection with human immunodeficiency virus (HIV)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EUS-RFA using Habib Tm as a probe3 EUS-RFA interventions at 1-month interval | Device | 3 radiofrequency ablation procedures |
| EUSStandard intervention | Procedure or surgery | standard medical care |
Primary outcome
Survival
Time frame: 1 month
Duration of survival
Survival
Time frame: at time of death on average 10months
Duration of survival
6 secondary outcomes
Quality of life (HEALTH, SOCIAL INTERACTIONS, DAILY ACTIVITIES)
Time frame: 1 month
Quality of life (HEALTH, SOCIAL INTERACTIONS, DAILY ACTIVITIES)
Time frame: Time of death on average 10 months
Pain reduction
Time frame: 1 month
Pain reduction
Time frame: Time of death on average 10months
Tumour Size
Time frame: 4 months
Monitoring of Adverse reactions
Time frame: At time of death on average 10months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ANAND V SAHAI, MD principal investigator
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EUS-RFA using Habib Tm as a probe and EUS in people with Pancreatic Ductal Adenocarcinoma, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.