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2019-09-12
2020-06-12
2020-06-12
45
NCT06371716
IRCCS San Raffaele
IRCCS San Raffaele
INTERVENTIONAL
Ex-vivo Ultrasound Guided Radiofrequency Ablation on Pancreatic Solid Lesions
The study investigates the feasibility and the efficacy to treat pancreatic solid lesions as pancreatic adenocarcinomas (PDAC) and neuroendocrine tumors (NET) with ex-vivo radiofrequency ablation (RFA) under ultrasound (US) control. 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).
A probe specifically designed for Endoscopic Ultrasound (EUS) in vivo treatment of human pancreatic solid masses will be used. The probe is connected to a radiofrequency generator on which the power can be set and the tip of the probe (on the tip is present the radiofrequency electrode) is continuously perfused by chilled solution. The generator can stop the power supply when the tissue impedance goes beyond the threshold value to prevent tissue carbonization
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2024-03-25 | N/A | 2024-04-15 |
2024-04-15 | N/A | 2024-04-17 |
2024-04-17 | N/A | 2024-04 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Non Randomized
Interventional Model:
Parallel
Masking:
Double
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: resected PDAC without neoadjuvant chemotherapy treatment Subgroup A: 10 W (5 patients) Subgroup B: 30 W (5 patients) Subgroup C: 50 W (5 patients) | PROCEDURE: ex-vivo RFA under US control at 10 Watts (W) of power in 3 differents arms of lesions
PROCEDURE: ex-vivo RFA under US control at 30 Watts (W) of power in 3 differents arms of lesions
PROCEDURE: ex-vivo RFA under US control at 50 Watts (W) of power in 3 differents arms of lesions
|
| EXPERIMENTAL: resected PDAC with neoadjuvant chemotherapy treatment Subgroup A: 10 W (5 patients) Subgroup B: 30 W (5 patients) Subgroup C: 50 W (5 patients) | PROCEDURE: ex-vivo RFA under US control at 10 Watts (W) of power in 3 differents arms of lesions
PROCEDURE: ex-vivo RFA under US control at 30 Watts (W) of power in 3 differents arms of lesions
PROCEDURE: ex-vivo RFA under US control at 50 Watts (W) of power in 3 differents arms of lesions
|
| EXPERIMENTAL: resected neuroendocrine tumors Subgroup A: 10 W (5 patients) Subgroup B: 30 W (5 patients) Subgroup C: 50 W (5 patients) | PROCEDURE: ex-vivo RFA under US control at 10 Watts (W) of power in 3 differents arms of lesions
PROCEDURE: ex-vivo RFA under US control at 30 Watts (W) of power in 3 differents arms of lesions
PROCEDURE: ex-vivo RFA under US control at 50 Watts (W) of power in 3 differents arms of lesions
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| diameter (millimeters) of coagulative necrosis obtained by RadioFrequency Ablation | assesses by two blinded pathologists | within 15-20 days |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
