Neuroendocrine TumorsRAPNENNCT03834701
Endoscopic Ultrasound-guided RadioFrequency Ablation for the Treatment Pancreatic NeuroEndocrine Neoplasms
A study testing EUS guided radiofrequency ablation in people with Neuroendocrine Tumors and Neuroendocrine Carcinoma, run by Catholic University of the Sacred Heart at 2 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Neuroendocrine Tumors, Neuroendocrine Carcinoma, Pancreas Neoplasm
- What is being tested?
- EUS guided radiofrequency ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Sep 2019to 1 Feb 2024
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For all patients
- Age ≥18 years and <80 years
- Signed written informed consent
- Distance from the main pancreatic duct ≥2mm
- Able to undergo endoscopic ultrasound examination
- Homogeneous enhancement at contrast harmonic EUS (CH-EUS)
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- For patients with functional pancreatic neuroendocrine neoplasms (F-PanNENs), almost all insulinomas
- Definitive diagnosis of a clinical syndrome related to excessive insulin secretion fasting test, insulin blood levels, C-peptide blood levels)
- Single lesion visualized at CT, and/or MRI, and/or EUS
- Size < 20mm
- For patients with non functional pancreatic neuroendocrine neoplasms (NF-PanNENs)
- EUS fine needle biopsy (FNB) proven NF-PanNENs
- 68Ga-DOTATATE PET/CT positive for a pancreatic lesion and negative for lymph nodes, liver, and other distant metastases
- Hyper- or Iso-enhancing pattern at MRI and/or CT with negative lymph nodes, liver, and other distant metastases
- G1 or G2 ≤ 5% on histological examination of EUS-guided biopsy samples utilizing EUS-FNB needles
- Diameter between 15mm and 25mm,
- Absence of symptoms
- Absence of inner calcifications
Who cannot join
- For all patients
- Known bleeding disorder that cannot be sufficiently corrected with co-fact or fresh frozen plasma (FFP)
- Use of anticoagulants that cannot be discontinued
- INR >1.5 or platelet count <50.000
- Previous inclusion in other studies
- Pregnancy
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- Minimal distance from the main pancreatic duct <1mm
- Inability to sign the informed consent
- Heterogeneous enhancement at contrast harmonic EUS (CH-EUS)
- For patients with F-PanNENs (almost all insulinomas)
- Diagnosis work up negative excessive hormone secretion syndrome
- Multiple lesions visualized at CT, and/or MRI, and/or EUS
- Size > 20mm
- For patients with NF-PanNENs
- G2>5% or G3 on histological examination of EUS-guided biopsy samples
- Diameter <15 mm and >25 mm
- Presence of symptoms
- Presence of calcifications
- Hypo-enhancing pattern at MRI and/or CT
- 68Ga-DOTATATE PET/CT positive for lymph nodes, liver, and other distant metastasis
- Diagnosis on multiple endocrine neoplasia type 1 (MEN1) syndrome or Von Hippel Lindau syndrome
- Previous inclusion in other studies
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Fondazione Policlinico Universitario Agostino Gemelli
Roma, RM, 00168
Universita' del Sacro Cuore
Rome, 00136
About this study
Official title: Safety and Efficacy of Endoscopic Ultrasound-guided RadioFrequency Ablation for the Treatment of Functional and Non-functional Pancreatic NeuroEndocrine Neoplasms: A Multicenter Prospective Study
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.
Read the detailed description
Pancreatic neuroendocrine neoplasms (PanNENs) are rare, but their incidence has significantly increased in the last decades. The mainstay treatment of PanNENs is surgery, which is associated with a significant benefit in term of survival but also with significant short- and long-term adverse events.
Based on the above data, less invasive alternative therapeutic interventions to avoid short- and long-term adverse events of surgery are needed.
In this context radiofrequency ablation has been reported to be effective in the treatment of these tumors in absence of major adverse events. However, the available studies on the matter are limited by small sample size and lack of standardized criteria for patient selection.
- Conditions
- Neuroendocrine Tumors, Neuroendocrine Carcinoma, Pancreas Neoplasm, Neuroendocrine Tumor Gastrointestinal, Hormone-Secreting
- Being tested
- EUS guided radiofrequency ablation
- Medical subject headings
- Neuroendocrine Tumors, Carcinoma, Neuroendocrine, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUS guided radiofrequency ablationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| EUS guided radiofrequency ablation | Experimental | Radiofrequency ablation will be performed using a system that 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. Receives: Device: EUS guided radiofrequency ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AEs) after EUS-guided radiofrequency ablation (RFA)
AEs will be classified as procedural when they occur during the procedure; post-procedural when they will occur up to 14 days after the procedure; late when they will occur more than 14 days after the procedure. Minor AEs will be those that need no therapy and have no sequelae (A) or have minor therapy or consequence, including overnight admission (B). Major events include those that require major therapy or hospitalization (24- 48 hours) (C); major therapy, need unplanned increase in level of care, or hospitalization >48 hours (D); or result in permanent adverse sequelae (E) and death (F).
Measured: 1 year
Secondary outcomes (1)
Rates of secondary surgery
Number of patients who will require secondary surgey due to adverse events occurence, no response/failed or partial/recurrence outcome to the RFA treatment
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2019
- Study start1 Sep 2019
- Primary completion1 Jan 2024
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neuroendocrine TumorsStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guido Costamagna, Catholic University of the Sacred Heart
- Investigators
- Alberto Larghi, PhD, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03834701
- Sponsor's protocol ID
- RAPNEN
- Acronym
- RAPNEN
- Status last verified
- Feb 2024
- First submitted
- 4 Feb 2019
- Last updated
- 13 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hofland J, de Herder WW, Kann PH. Turning Up the Heat: Endoscopic Ablation of Pancreatic Neuroendocrine Neoplasms. J Clin Endocrinol Metab. 2019 Nov 1;104(11):5053-5055. doi: 10.1210/jc.2019-00954. No abstract available.
PubMed 31058975
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Endoscopic Ultrasound-guided RadioFrequency Ablation for the Treatment of Functional and Non-functional Pancreatic NeuroEndocrine Neoplasms: A Multicenter Prospective Study
- ClinicalTrials.gov ID
- NCT03834701
- Acronym / sponsor ID
- RAPNEN / RAPNEN
- Conditions
- Neuroendocrine Tumors, Neuroendocrine Carcinoma, Pancreas Neoplasm, Neuroendocrine Tumor Gastrointestinal, Hormone-Secreting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 8 Feb 2019 (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.
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.
Detailed description
Pancreatic neuroendocrine neoplasms (PanNENs) are rare, but their incidence has significantly increased in the last decades. The mainstay treatment of PanNENs is surgery, which is associated with a significant benefit in term of survival but also with significant short- and long-term adverse events.
Based on the above data, less invasive alternative therapeutic interventions to avoid short- and long-term adverse events of surgery are needed.
In this context radiofrequency ablation has been reported to be effective in the treatment of these tumors in absence of major adverse events. However, the available studies on the matter are limited by small sample size and lack of standardized criteria for patient selection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EUS guided radiofrequency ablation | Experimental | Device: EUS guided radiofrequency ablationRadiofrequency ablation will be performed using a system that 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- For all patients
- Age ≥18 years and <80 years
- Signed written informed consent
- Distance from the main pancreatic duct ≥2mm
- Able to undergo endoscopic ultrasound examination
Key exclusion criteria (22 listed)
- For all patients
- Known bleeding disorder that cannot be sufficiently corrected with co-fact or fresh frozen plasma (FFP)
- Use of anticoagulants that cannot be discontinued
- INR >1.5 or platelet count <50.000
- Previous inclusion in other studies
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 |
|---|---|---|
| EUS guided radiofrequency ablationThe 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. | Device | EUS guided radiofrequency ablation |
Primary outcome
Incidence of adverse events (AEs) after EUS-guided radiofrequency ablation (RFA)
Time frame: 1 year
AEs will be classified as procedural when they occur during the procedure; post-procedural when they will occur up to 14 days after the procedure; late when they will occur more than 14 days after the procedure. Minor AEs will be those that need no therapy and have no sequelae (A) or have minor therapy or consequence, including overnight admission (B). Major events include those that require major therapy or hospitalization (24- 48 hours) (C); major therapy, need unplanned increase in level of care, or hospitalization >48 hours (D); or result in permanent adverse sequelae (E) and death (F).
1 secondary outcome
Rates of secondary surgery
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Derived from this study: PubMed 31058975Hofland J, de Herder WW, Kann PH. Turning Up the Heat: Endoscopic Ablation of Pancreatic Neuroendocrine Neoplasms. J Clin Endocrinol Metab. 2019 Nov 1;104(11):5053-5055. doi: 10.1210/jc.2019-00954. No abstract available.
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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.
Alberto Larghi, PhD principal investigator
Fondazione Policlinico Universitario Agostino Gemelli
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EUS guided radiofrequency ablation in people with Neuroendocrine Tumors and Neuroendocrine Carcinoma, run by Catholic University of the Sacred Heart at 2 sites 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 18 inclusion and 22 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: finished, as of the sponsor's last update on 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of adverse events (AEs) after EUS-guided radiofrequency ablation (RFA) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03834701, which also lists 1 linked publication.
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 13 Feb 2024.