EUS-guided radiofrequency ablation for pancreatic neuroendocrine neoplasms

JRCT ID: jRCTs062230014

Registered date:12/05/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Pancreatic neuroendocrine neoplasms
• Date of first enrollment: 17/08/2023
• Target sample size: 5
• Study type: Interventional
• Intervention(s): Radiofrequency ablation for tumor under EUS-guidance

Outcome(s)

• Primary Outcome: Safety

Secondary Outcome

1. Efficacy(1 and 6 months after procedure)
2. Detail of procedure
3. Failure of procedure equipment
4. Development or exacerbation of diabetes mellitus(6 months after procedure)
5. Survival at 6 months after procedure

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Age more than 18 years old
2. Patient who have been fully informed consent.
3. Pathologically confirmed PNEN with grade by EUS-FNA (WHO 2017 classification)
4. Tumor size 15 mm or less on CE-CT
5. non-functionnal PNEN or insulinom

Exclude criteria

1. Allergy for contrast medium
2. Placement of a cardiac pacemaker
3. Within 2 mm of the distance between tumor and main pancreatic duct on radiographic images
4. Suspect of lymph node metastasis or distant metastasis on CE-CT.
5. Less than 50% of PT or less than 1.5 of INR
6. Less than 50,000 per microliter of PLT
7. Less than 30 mL/min/1.73m2 of eGFR
8. Administeration of more than 2 antithrombotic agents
9. Not less than 2 of performance status
10. Being pregnant or possibly pregnant
11. Less than 5 years of estimated prognosis
12. Patients judged as inappropriate candidate by the chief medical examiner

Related Information

• Primary Sponsor: Matsumoto Kazuyuki
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development