Pancreatic Ductal Adenocarcinoma (PDAC)PERFECTNCT07850336
Pancreatic Endoscopic Ultrasound-guided RadioFrequency for Inoperable Carcinoma Treatment
A study testing Endoscopic ultrasound-guided radiofrequency ablation in people with Pancreatic Ductal Adenocarcinoma (PDAC), run by Bojan Kovacevic.
Trial summary
The purpose of this study is to evaluate whether endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) affects survival in patients with inoperable pancreatic carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma (PDAC)
- What is being tested?
- Endoscopic ultrasound-guided radiofrequency ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Adult habile patients with a signed informed consent
- Histologically confirmed pancreatic carcinoma ≤5 cm in largest diameter
- ECOG performance status 0-2
- Patients not eligible for curative-intended surgical treatment due to:
- Advanced (unresectable) disease, or Unsuitability for surgery due to comorbidities or poor performance status, or Patient preference to decline surgery
Who cannot join
- Metastatic disease
- Uncorrected coagulopathy (INR ≥1.5 or thrombocyte count < 50 mia/L)
- Altered anatomy or interposition of major vessels precluding safe EUS-RFA
- Active untreated infection or pancreatitis
- Life expectancy <3 months
- Prior local ablative treatment interfering with outcome
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Pancreatic Endoscopic Ultrasound-guided RadioFrequency for Inoperable Carcinoma Treatment (PERFECT Study)
The purpose of this study is to evaluate whether endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) affects survival in patients with inoperable pancreatic carcinoma. By using a prospective single-arm design with historical controls, this study aims to generate clinically relevant data while minimizing the number of patients exposed to experimental treatment. The findings may support future integration of EUS-RFA into standard care for this high-need patient population.
- Conditions
- Pancreatic Ductal Adenocarcinoma (PDAC)
- Being tested
- Endoscopic ultrasound-guided radiofrequency ablation
- Keywords
- EUS-RFA, Endoscopic Ultrasound-Guided Radiofrequency Ablation, Locally Advanced Pancreatic Cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic ultrasound-guided radiofrequency ablationProcedure or surgery
Also called EUS-RFA
A 19G RFA needle (EUSRA, STARMed, Gyeonggi-do, South Korea) is introduced through the working channel of an echoendoscope and advanced into the pancreatic tumor under real-time ultrasound guidance.
The needle is connected to a dedicated RF generator delivering a current of 400-500 kHz, which induces coagulative necrosis in the targeted tissue. Treatment is continued until complete ablation is confirmed ultrasonographically, or until an impedance value of 800 Ω is reached, at which point the generator automatically terminates power output to limit further tissue damage. A cooling pump circulates chilled saline through the needle to reduce charring at the ablation site. The procedure is performed transgastrically or transduodenally under deep sedation or general anesthesia, and may involve one or more ablation cycles per session. Treatment may be repeated at approximately 4-week intervals, depending on radiological response and patient tolerance.
| Study group | Role | What they receive |
|---|---|---|
| EUS-RFA plus standard oncological treatment | Experimental | Participants receive endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) using a 19G RFA needle (EUSRA, STARMed, Gyeonggi-do, South Korea) connected to an RF generator, as a supplement to standard palliative oncological treatment. EUS-RFA is performed under deep sedation or general anesthesia and may be repeated at approximately 4-week intervals contingent on patient condition. All participants continue standard oncological follow-up, including systemic therapy and regular cross-sectional imaging, in parallel with the study intervention. Receives: Procedure: Endoscopic ultrasound-guided radiofrequency ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Time from index date (first day of systemic oncological therapy or first visit at the Department of Oncology (for patients who do not receive systemic therapy)) to death from any cause. Participants alive at the time of last follow-up will be censored at that date.
Measured: From index date until death from any cause, assessed up to 4 years
Secondary outcomes (7)
Progression- and metastatic-free survival
Time from index date to radiological progression of the primary tumor or development of distant metastases, assessed according to RECIST 1.1 on cross-sectional imaging.
Measured: From index date until progression, metastasis, or last follow-up, assessed up to approximately 4 years
Local tumor control at 6 and 12 months
Proportion of participants with local tumor control (absence of local progression) on cross-sectional imaging at 6 and 12 months, assessed according to RECIST 1.1.
Measured: At 6 and 12 months after index date
Procedure-related adverse events
Adverse events occurring within 30 days of each EUS-RFA treatment, graded according to the AGREE classification.
Measured: At 30 days after each EUS-RFA procedure
Time to biliary/duodenal intervention
Time from index date to first biliary or duodenal intervention (e.g., stenting)
Measured: From index date until intervention or last follow-up, assessed up to approximately 4 years
Pain score change compared to baseline
Change from baseline in pain severity, measured using a Numeric Rating Scale (NRS, 0-10)
Measured: Baseline and at 6, 12 and 18 months after inclusion
Opioid consumption change compared to baseline
Change in opioid consumption, converted to total daily oral morphine milligram equivalent (MME).
Measured: Baseline and at 6, 12 and 18 months after inclusion
Quality of Life change compared to baseline (EORTC QLQ-C30)
Change from baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), Global Health Status/Quality of Life scale, ranging from 0 (worst) to 100 (best), with higher scores indicating better quality of life.
Measured: Baseline and at 6, 12 and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Ductal Adenocarcinoma (PDAC)Studies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- A historical control group will be used as a comparitor.
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bojan Kovacevic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bojan Kovacevic, Herlev Hospital
- Investigators
- Bojan Kovacevic, MD, PhD, Principal investigator, Herlev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07850336
- Sponsor's protocol ID
- 16-0302-148
- Acronym
- PERFECT
- Status last verified
- Jul 2026
- First submitted
- 17 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pancreatic Endoscopic Ultrasound-guided RadioFrequency for Inoperable Carcinoma Treatment (PERFECT Study)
- ClinicalTrials.gov ID
- NCT07850336
- Acronym / sponsor ID
- PERFECT / 16-0302-148
- Conditions
- Pancreatic Ductal Adenocarcinoma (PDAC)
- Keywords
- EUS-RFA, Endoscopic Ultrasound-Guided Radiofrequency Ablation, Locally Advanced Pancreatic Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Bojan KovacevicUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 30 Sep 2026 (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.
The purpose of this study is to evaluate whether endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) affects survival in patients with inoperable pancreatic carcinoma. By using a prospective single-arm design with historical controls, this study aims to generate clinically relevant data while minimizing the number of patients exposed to experimental treatment. The findings may support future integration of EUS-RFA into standard care for this high-need patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A historical control group will be used as a comparitor.
| Arm | Type | Receives |
|---|---|---|
| EUS-RFA plus standard oncological treatment | Experimental | Procedure: Endoscopic ultrasound-guided radiofrequency ablationParticipants receive endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) using a 19G RFA needle (EUSRA, STARMed, Gyeonggi-do, South Korea) connected to an RF generator, as a supplement to standard palliative oncological treatment. EUS-RFA is performed under deep sedation or general anesthesia and may be repeated at approximately 4-week intervals contingent on patient condition. All participants continue standard oncological follow-up, including systemic therapy and regular cross-sectional imaging, in parallel with the study intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult habile patients with a signed informed consent
- Histologically confirmed pancreatic carcinoma ≤5 cm in largest diameter
- ECOG performance status 0-2
- Patients not eligible for curative-intended surgical treatment due to:
- Advanced (unresectable) disease, or Unsuitability for surgery due to comorbidities or poor performance status, or Patient preference to decline surgery
Key exclusion criteria (6 listed)
- Metastatic disease
- Uncorrected coagulopathy (INR ≥1.5 or thrombocyte count < 50 mia/L)
- Altered anatomy or interposition of major vessels precluding safe EUS-RFA
- Active untreated infection or pancreatitis
- Life expectancy <3 months
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 |
|---|---|---|
| Endoscopic ultrasound-guided radiofrequency ablationAlso: EUS-RFAA 19G RFA needle (EUSRA, STARMed, Gyeonggi-do, South Korea) is introduced through the working channel of an echoendoscope and advanced into the pancreatic tumor under real-time ultrasound guidance. The needle is connected to a dedicated RF generator delivering a current of 400-500 kHz, which induces coagulative necrosis in the targeted tissue. Treatment is continued until complete ablation is confirmed ultrasonographically, or until an impedance value of 800 Ω is reached, at which point the generator automatically terminates power output to limit further tissue damage. A cooling pump circulates chilled saline through the needle to reduce charring at the ablation site. The procedure is performed transgastrically or transduodenally under deep sedation or general anesthesia, and may involve one or more ablation cycles per session. Treatment may be repeated at approximately 4-week intervals, depending on radiological response and patient tolerance. | Procedure or surgery | EUS-RFA plus standard oncological treatment |
Primary outcome
Overall survival
Time frame: From index date until death from any cause, assessed up to 4 years
Time from index date (first day of systemic oncological therapy or first visit at the Department of Oncology (for patients who do not receive systemic therapy)) to death from any cause. Participants alive at the time of last follow-up will be censored at that date.
7 secondary outcomes
Progression- and metastatic-free survival
Time frame: From index date until progression, metastasis, or last follow-up, assessed up to approximately 4 years
Local tumor control at 6 and 12 months
Time frame: At 6 and 12 months after index date
Procedure-related adverse events
Time frame: At 30 days after each EUS-RFA procedure
Time to biliary/duodenal intervention
Time frame: From index date until intervention or last follow-up, assessed up to approximately 4 years
Pain score change compared to baseline
Time frame: Baseline and at 6, 12 and 18 months after inclusion
Opioid consumption change compared to baseline
Time frame: Baseline and at 6, 12 and 18 months after inclusion
Quality of Life change compared to baseline (EORTC QLQ-C30)
Time frame: Baseline and at 6, 12 and 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
Bojan Kovacevic, MD, PhD principal investigator
Herlev Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic ultrasound-guided radiofrequency ablation in people with Pancreatic Ductal Adenocarcinoma (PDAC), run by Bojan Kovacevic.
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 5 inclusion and 6 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: opening soon, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clara Søndersted, MD (45 38683868, clara.theodora.soendersted@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: From index date until death from any cause, assessed up to 4 years). 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 30 Sep 2026.