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Pancreatic Endoscopic Ultrasound-guided RadioFrequency for Inoperable Carcinoma Treatment

ConditionPancreatic Ductal Adenocarcinoma (PDAC)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBojan Kovacevic

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult habile patients with a signed informed consent

Histologically confirmed pancreatic carcinoma ≤5 cm in largest diameter

ECOG performance status 0-2

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Endoscopic ultrasound-guided radiofrequency ablation

    Procedure/Surgery

    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.

Treatment groups

56 Participants
are divided into 1 treatment group
Group A: EUS-RFA plus standard oncological treatmentExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
From index date until death from any cause, assessed up to 4 years

Secondary outcomes

1

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.

Time frame
From index date until progression, metastasis, or last follow-up, assessed up to approximately 4 years
2

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.

Time frame
At 6 and 12 months after index date
3

Procedure-related adverse events

Adverse events occurring within 30 days of each EUS-RFA treatment, graded according to the AGREE classification.

Time frame
At 30 days after each EUS-RFA procedure
4

Time to biliary/duodenal intervention

Time from index date to first biliary or duodenal intervention (e.g., stenting)

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bojan Kovacevic

Lead sponsor

Herlev Hospital

Sponsor institution

Source ClinicalTrials.gov

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