Pancreatic Endoscopic Ultrasound-guided RadioFrequency for Inoperable Carcinoma Treatment

NCT07850336 | Not Yet Recruiting DMC

• 1 other identifier: 16-0302-148
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

Brief 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. 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)

Keywords

EUS-RFA; Endoscopic Ultrasound-Guided Radiofrequency Ablation; Locally Advanced Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Progression- and metastatic-free survival

  From index date until progression, metastasis, or last follow-up, assessed up to approximately 4 years

• Local tumor control at 6 and 12 months

  At 6 and 12 months after index date

• Procedure-related adverse events

  At 30 days after each EUS-RFA procedure

• Time to biliary/duodenal intervention

  From index date until intervention or last follow-up, assessed up to approximately 4 years

• Pain score change compared to baseline

  Baseline and at 6, 12 and 18 months after inclusion

Study Arms (1)

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.

Procedure: Endoscopic ultrasound-guided radiofrequency ablation

Interventions

Endoscopic ultrasound-guided radiofrequency ablation PROCEDURE

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.

Also known as: EUS-RFA

EUS-RFA plus standard oncological treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bojan Kovacevic: lead

Study Officials

• Bojan Kovacevic, MD, PhD

  Herlev Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clara Søndersted, MD

CONTACT

45 38683868; clara.theodora.soendersted@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Consultant Surgeon, Surgical Gastroenterology, Sponsor-Investigator

Model Details: A historical control group will be used as a comparitor.

Study Record Dates

• First Submitted: September 17, 2026
• First Posted: September 30, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: September 30, 2026

Record last verified: 2026-07