Endoscopic Ultrasound-guided RadioFrequency Ablation for the Treatment Pancreatic NeuroEndocrine Neoplasms

NCT ID: NCT03834701

Last Updated: 2024-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2024-02-01

Brief 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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

EUS guided radiofrequency ablation

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.

Group Type: EXPERIMENTAL

EUS guided radiofrequency ablation

Intervention Type: DEVICE

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.

Interventions

EUS guided radiofrequency ablation

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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)

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

Exclusion Criteria

• 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
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Catholic University of the Sacred Heart

OTHER

Sponsor Role: lead

Responsible Party

Guido Costamagna

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alberto Larghi, PhD

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Universitario Agostino Gemelli

Locations

Fondazione Policlinico Universitario Agostino Gemelli

Roma, RM, Italy

Universita' del Sacro Cuore

Rome, , Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 31058975 (View on PubMed)

Other Identifiers

RAPNEN

Identifier Type: -

Identifier Source: org_study_id