Endoscopic Ultrasound-guided RadioFrequency Ablation for the Treatment Pancreatic NeuroEndocrine Neoplasms
NCT03834701 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2024-02-13
Summary
This study evaluates the possibility and the safety of performing local therapy for Pancreatic neuroendocrine neoplasms (PanNENs) using radiofrequency ablation of the tumor under ultrasonography (EUS) guidance.
Conditions
- Neuroendocrine Tumors
- Neuroendocrine Carcinoma
- Pancreas Neoplasm
- Neuroendocrine Tumor Gastrointestinal, Hormone-Secreting
Interventions
- DEVICE
-
EUS guided radiofrequency ablation
The EUS-RFA system (Taewoong, Seoul, Korea) utilized for EUS-RFA consists of an 19-gauge needle electrode (140-cm long), a radiofrequency generator, and an inner cooling system that circulates chilled saline solution during the RFA procedure. The inner metal part is insulated over its entire length, with the exception of the terminal 5 to 20mm for energy delivery. The needle electrode is attached to a radio frequency current generator (VIVA RF generator; Taewoong) and to a cooling pump. The generator, in addition to providing radio frequency current, allows the control of physical power and impedance parameters.
Sponsors & Collaborators
-
Catholic University of the Sacred Heart
lead OTHER
Principal Investigators
-
Alberto Larghi, PhD · Fondazione Policlinico Universitario Agostino Gemelli
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-09-01
- Primary Completion
- 2024-01-01
- Completion
- 2024-02-01
Countries
- Italy
Study Locations
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