Pancreatic Endoscopic Ultrasound-guided RadioFrequency for Inoperable Carcinoma Treatment (PERFECT)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pancreatic Ductal Adenocarcinoma (PDAC)
• Intervention / Treatment: Procedure: Endoscopic ultrasound-guided radiofrequency ablation

• Study Type: Interventional
• Enrollment (Estimated): 56
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clara Søndersted, MD; Phone Number: 45 38683868; Email: clara.theodora.soendersted@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: EUS-RFA plus standard oncological treatment; 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.

Procedure: Endoscopic ultrasound-guided radiofrequency ablation; 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.; Other Names: EUS-RFA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From index date until death from any cause, assessed up to 4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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)	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)	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).	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.	Baseline and at 6, 12 and 18 months

Collaborators and Investigators

• Sponsor: Bojan Kovacevic
• Investigators: Principal Investigator: Bojan Kovacevic, MD, PhD, Herlev Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: September 17, 2026
• First Submitted That Met QC Criteria: September 24, 2026
• First Posted (Actual): September 30, 2026

Study Record Updates

• Last Update Posted (Actual): September 30, 2026
• Last Update Submitted That Met QC Criteria: September 24, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Locally Advanced Pancreatic Cancer; EUS-RFA; Endoscopic Ultrasound-Guided Radiofrequency Ablation
• Other Study ID Numbers: 16-0302-148

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No