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Ex-vivo Ultrasound Guided Radiofrequency Ablation on Pancreatic Solid Lesions

NCT06371716 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2024-04-17

No results posted yet for this study

Summary

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).

Conditions

Interventions

PROCEDURE

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

PROCEDURE

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

PROCEDURE

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

Sponsors & Collaborators

  • IRCCS San Raffaele

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-12
Primary Completion
2020-06-12
Completion
2020-06-12

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06371716 on ClinicalTrials.gov