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NOT YET RECRUITING
NCT07850336
NA

Pancreatic Endoscopic Ultrasound-guided RadioFrequency for Inoperable Carcinoma Treatment

Sponsor: Bojan Kovacevic

View on ClinicalTrials.gov

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.

Official title: Pancreatic Endoscopic Ultrasound-guided RadioFrequency for Inoperable Carcinoma Treatment (PERFECT Study)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

56

Start Date

2026-10-01

Completion Date

2030-12

Last Updated

2026-09-30

Healthy Volunteers

No

Interventions

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.