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Efficacy and Safety of EUS-guided radiofrequency ablation for hepaticopancreatic neoplasms

EUS-guided radiofrequency ablation for hepaticopancreatic neoplasms

Matsumoto Kazuyuki

Okayama University Hospital

2-5-1, Shikata-cho, Kita-ku, Okayama city, Okayama

matsumoto.k@okayama-u.ac.jp

Matsumoto Kazuyuki

Okayama University Hospital

2-5-1, Shikata-cho, Kita-ku, Okayama city, Okayama

+81-86-235-7219

matsumoto.k@okayama-u.ac.jp

Recruiting

Mar. 10, 2025

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

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.

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.

Both

NEN, SPN, HCC

Radiofrequency ablation for tumors under EUS-guidance

Proportion of complete tumor ablation (at 1 and 6 months)

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

+81-86-235-6503

Mar. 06, 2025

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