Ex-vivo Ultrasound Guided Radiofrequency Ablation on Pancreatic Solid Lesions
NCT ID: NCT06371716
Last Updated: 2024-04-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
NA
45 participants
INTERVENTIONAL
2019-09-12
2020-06-12
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The study intent is to define the optimal radiofrequency ablation POWER of the system in terms of maximum sizes (diameters) of histological coagulative necrosis obtained at pathological samples. Results will be useful to define the optimal settings to ablate pancreatic solid lesions (PDAC and neuroendocrine tumours).
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
EUS-guided Laser Ablation in Pancreatic Adenocarcinoma
NCT03784417
EUS-RFA for Unresectable Pancreatic Ductal Adenocarcinoma
NCT03772756
EUS-guided RFA for Pancreatic Neoplasms
NCT03218345
Magnetic Resonance-guided High-intensity Focused Ultrasound Treatment of Locally Advanced Pancreatic Cancer
NCT01786850
EUS-RFA for Unresectable Pancreatic Cancer
NCT04310111
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
Each group (15 patients each) Subgroup A: 10 W (5 patients) Subgroup B: 30 W (5 patients) Subgroup C: 50 W (5 patients)
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
resected PDAC without neoadjuvant chemotherapy treatment
Subgroup A: 10 W (5 patients) Subgroup B: 30 W (5 patients) Subgroup C: 50 W (5 patients)
ex-vivo RFA under US control at 10 Watts (W) of power in 3 differents arms of lesions
5 PDAC with neoadjuvant chemotherapy treated at 10 W with ex-vivo RFA 5 PDAC without previous neoadjuvant chemotherapy treated at 10 W with ex-vivo RFA 5 NET treated at 10 W with ex-vivo RFA
ex-vivo RFA under US control at 30 Watts (W) of power in 3 differents arms of lesions
5 PDAC with neoadjuvant chemotherapy 5 PDAC without previous neoadjuvant chemotherapy 5 NETs
ex-vivo RFA under US control at 50 Watts (W) of power in 3 differents arms of lesions
5 PDAC with neoadjuvant chemotherapy 5 PDAC without previous neoadjuvant chemotherapy 5 NETs
resected PDAC with neoadjuvant chemotherapy treatment
Subgroup A: 10 W (5 patients) Subgroup B: 30 W (5 patients) Subgroup C: 50 W (5 patients)
ex-vivo RFA under US control at 10 Watts (W) of power in 3 differents arms of lesions
5 PDAC with neoadjuvant chemotherapy treated at 10 W with ex-vivo RFA 5 PDAC without previous neoadjuvant chemotherapy treated at 10 W with ex-vivo RFA 5 NET treated at 10 W with ex-vivo RFA
ex-vivo RFA under US control at 30 Watts (W) of power in 3 differents arms of lesions
5 PDAC with neoadjuvant chemotherapy 5 PDAC without previous neoadjuvant chemotherapy 5 NETs
ex-vivo RFA under US control at 50 Watts (W) of power in 3 differents arms of lesions
5 PDAC with neoadjuvant chemotherapy 5 PDAC without previous neoadjuvant chemotherapy 5 NETs
resected neuroendocrine tumors
Subgroup A: 10 W (5 patients) Subgroup B: 30 W (5 patients) Subgroup C: 50 W (5 patients)
ex-vivo RFA under US control at 10 Watts (W) of power in 3 differents arms of lesions
5 PDAC with neoadjuvant chemotherapy treated at 10 W with ex-vivo RFA 5 PDAC without previous neoadjuvant chemotherapy treated at 10 W with ex-vivo RFA 5 NET treated at 10 W with ex-vivo RFA
ex-vivo RFA under US control at 30 Watts (W) of power in 3 differents arms of lesions
5 PDAC with neoadjuvant chemotherapy 5 PDAC without previous neoadjuvant chemotherapy 5 NETs
ex-vivo RFA under US control at 50 Watts (W) of power in 3 differents arms of lesions
5 PDAC with neoadjuvant chemotherapy 5 PDAC without previous neoadjuvant chemotherapy 5 NETs
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ex-vivo RFA under US control at 10 Watts (W) of power in 3 differents arms of lesions
5 PDAC with neoadjuvant chemotherapy treated at 10 W with ex-vivo RFA 5 PDAC without previous neoadjuvant chemotherapy treated at 10 W with ex-vivo RFA 5 NET treated at 10 W with ex-vivo RFA
ex-vivo RFA under US control at 30 Watts (W) of power in 3 differents arms of lesions
5 PDAC with neoadjuvant chemotherapy 5 PDAC without previous neoadjuvant chemotherapy 5 NETs
ex-vivo RFA under US control at 50 Watts (W) of power in 3 differents arms of lesions
5 PDAC with neoadjuvant chemotherapy 5 PDAC without previous neoadjuvant chemotherapy 5 NETs
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Exclusion Criteria
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
IRCCS San Raffaele
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Paolo Giorgio Arcidiacono, MD
Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
IRCCS San Raffaele Hospital
Milan, , Italy
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EUS-RFA ex-vivo 2016
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.