Pancreatic CancerNCT06371716
Ex-vivo Ultrasound Guided Radiofrequency Ablation on Pancreatic Solid Lesions
A study of Pancreatic Cancer and Endoscopic Ultrasound, run by IRCCS San Raffaele at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pancreatic Cancer, Endoscopic Ultrasound, Radiofrequency Ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteItaly
- Study dates
- 12 Sep 2019to 12 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Application of a New System of Ultrasound (US) Guided - Radiofrequency Ablation (RFA) on Explanted Pancreas From Patients With Solid Pancreatic Masses: Study of Efficacy
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).
Read the detailed description
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
- Being tested
- ex-vivo RFA under US control at 10 Watts (W) of power in 3 differents arms of lesions, ex-vivo RFA under US control at 30 Watts (W) of power in 3 differents arms of lesions, ex-vivo RFA under US control at 50 Watts (W) of power in 3 differents arms of lesions
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ex-vivo RFA under US control at 10 Watts (W) of power in 3 differents arms of lesionsProcedure or surgery
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 lesionsProcedure or surgery
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 lesionsProcedure or surgery
5 PDAC with neoadjuvant chemotherapy 5 PDAC without previous neoadjuvant chemotherapy 5 NETs
| Study group | Role | What they receive |
|---|---|---|
| resected PDAC without neoadjuvant chemotherapy treatment | Experimental | Subgroup A: 10 W (5 patients) Subgroup B: 30 W (5 patients) Subgroup C: 50 W (5 patients) Receives: 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 |
| resected PDAC with neoadjuvant chemotherapy treatment | Experimental | Subgroup A: 10 W (5 patients) Subgroup B: 30 W (5 patients) Subgroup C: 50 W (5 patients) Receives: 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 |
| resected neuroendocrine tumors | Experimental | Subgroup A: 10 W (5 patients) Subgroup B: 30 W (5 patients) Subgroup C: 50 W (5 patients) Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
diameter (millimeters) of coagulative necrosis obtained by RadioFrequency Ablation
assesses by two blinded pathologists
Measured: within 15-20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start12 Sep 2019
- Primary completion12 Jun 2020
- Study completion12 Jun 2020
Why it stopped: resectable pancreatic adenocarcinoma and neuroendocrine pancreatic neoplasms are difficult to be enrolled. Pancreatic resectable cancers are treated nowadays with chemotherapy and big neuroedocrine pancreatic lesions rare
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 15 resected PDAC without neoadjuvant treatment 15 resected PDAC with neoadjuvant treatment 15 resected neuroendocrine tumors Each group (15 patients each) Subgroup A: 10 W (5 patients) Subgroup B: 30 W (5 patients) Subgroup C: 50 W (5 patients)
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paolo Giorgio Arcidiacono, MD, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06371716
- Sponsor's protocol ID
- EUS-RFA ex-vivo 2016
- Status last verified
- Apr 2024
- First submitted
- 25 Mar 2024
- Last updated
- 17 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of a New System of Ultrasound (US) Guided - Radiofrequency Ablation (RFA) on Explanted Pancreas From Patients With Solid Pancreatic Masses: Study of Efficacy
- ClinicalTrials.gov ID
- NCT06371716
- Acronym / sponsor ID
- EUS-RFA ex-vivo 2016
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: resectable pancreatic adenocarcinoma and neuroendocrine pancreatic neoplasms are difficult to be enrolled. Pancreatic resectable cancers are treated nowadays with chemotherapy and big neuroedocrine pancreatic lesions rare
- Enrolment
- 45 participants (actual)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 12 Sep 2019 (actual)
- Primary completion
- 12 Jun 2020 (actual)
- Study completion
- 12 Jun 2020 (actual)
- First posted
- 17 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- 15 resected PDAC without neoadjuvant treatment 15 resected PDAC with neoadjuvant treatment 15 resected neuroendocrine tumors Each group (15 patients each) Subgroup A: 10 W (5 patients) Subgroup B: 30 W (5 patients) Subgroup C: 50 W (5 patients)
| Arm | Type | Receives |
|---|---|---|
| resected PDAC without neoadjuvant chemotherapy treatment | Experimental | 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 lesionsSubgroup A: 10 W (5 patients) Subgroup B: 30 W (5 patients) Subgroup C: 50 W (5 patients) |
| resected PDAC with neoadjuvant chemotherapy treatment | Experimental | 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 lesionsSubgroup A: 10 W (5 patients) Subgroup B: 30 W (5 patients) Subgroup C: 50 W (5 patients) |
| resected neuroendocrine tumors | Experimental | 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 lesionsSubgroup A: 10 W (5 patients) Subgroup B: 30 W (5 patients) Subgroup C: 50 W (5 patients) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ex-vivo RFA under US control at 10 Watts (W) of power in 3 differents arms of lesions5 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 or surgery | resected PDAC with neoadjuvant chemotherapy treatment, resected PDAC without neoadjuvant chemotherapy treatment, resected neuroendocrine tumors |
| ex-vivo RFA under US control at 30 Watts (W) of power in 3 differents arms of lesions5 PDAC with neoadjuvant chemotherapy 5 PDAC without previous neoadjuvant chemotherapy 5 NETs | Procedure or surgery | resected PDAC with neoadjuvant chemotherapy treatment, resected PDAC without neoadjuvant chemotherapy treatment, resected neuroendocrine tumors |
| ex-vivo RFA under US control at 50 Watts (W) of power in 3 differents arms of lesions5 PDAC with neoadjuvant chemotherapy 5 PDAC without previous neoadjuvant chemotherapy 5 NETs | Procedure or surgery | resected PDAC with neoadjuvant chemotherapy treatment, resected PDAC without neoadjuvant chemotherapy treatment, resected neuroendocrine tumors |
Primary outcome
diameter (millimeters) of coagulative necrosis obtained by RadioFrequency Ablation
Time frame: within 15-20 days
assesses by two blinded pathologists
Results and safety
The study was stopped early (reason given: resectable pancreatic adenocarcinoma and neuroendocrine pancreatic neoplasms are difficult to be enrolled. Pancreatic resectable cancers are treated nowadays with chemotherapy and big neuroedocrine pancreatic lesions rare). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Pancreatic Cancer and Endoscopic Ultrasound, run by IRCCS San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: resectable pancreatic adenocarcinoma and neuroendocrine pancreatic neoplasms are difficult to be enrolled. Pancreatic resectable cancers are treated nowadays with chemotherapy and big neuroedocrine pancreatic lesions rare). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diameter (millimeters) of coagulative necrosis obtained by RadioFrequency Ablation (time frame: within 15-20 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.