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

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.

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.

• EUS-RFA

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 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.

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.

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

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

Change from baseline in pain severity, measured using a Numeric Rating Scale (NRS, 0-10)

Change in opioid consumption, converted to total daily oral morphine milligram equivalent (MME).

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.