NEN, SPN, HCC
Conditions
Interventions
Radiofrequency ablation for tumors under EUS-guidance
Sponsors
Matsumoto Kazuyuki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 Individuals aged 18 years or older at the time of consent acquisition. 2 Individuals who have provided written consent based on their own free will after receiving sufficient explanation and fully understanding the details of the study. 3 The pancreatic tumor planned for treatment must be confirmed by pathological examination as one of the following: NEN with Grade 1(WHO2017 classification), or Solid Pseudopapillary Neoplasm(SPN). Note. A pathological examination is not required for liver tumors if blood tests and imaging findings are typical of hepatocellular carcinoma(HCC). 4 Tumor diameter must be within 20 mm, as confirmed by contrast enhanced CT. 5 For functional NEN, the tumor must be an insulinoma.
Exclusion criteria
Exclusion criteria: 1 History of allergy to contrast agents (iodine). 2 Presence of a cardiac pacemaker. 3 Distance to the main pancreatic duct is less than 2 mm on imaging (for pancreatic tumors). 4 Lymph node metastasis or distant organ metastasis suspected outside the treatment area on imaging. 5 Coagulation factor PT (prothrombin time) of 50% or less, or an INR (international normalized ratio) of 1.5 or higher. 6 Platelet count of 50.000 per microliter or less. 7 Creatinine clearance (eGFR) of less than 30 mL/min/1.73m2. 8 Oral administration of two or more antithrombotic drugs. 9 ECOG Performance Status (PS) of 2 to 4. 10 Child Pugh classification of C (for liver tumors). 11 Cases where treatment is possible with a percutaneous approach (for liver tumors). 12 Pregnancy or the possibility of being pregnant. 13 Other patients deemed unsuitable for the study by the principal investigator or coinvestigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of complete tumor ablation (at 1 and 6 months) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Response rate 2. Disappearance of hypoglycemic symptoms (for insulinomas only) 3. Safety 4. Failure of procedure equipment 5. Development or exacerbation of diabetes mellitus | — |
Contacts
Public ContactKazuyuki Matsumoto
Okayama University Hospital
Outcome results
None listed