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Safety and efficacy of EUS-guided radiofrequency ablation for pancreatic neuroendocrine neoplasms: Pilot study

EUS-guided radiofrequency ablation for pancreatic neuroendocrine neoplasms

5

The median age was 64 years (range: 46-71), with three males and two females. The median tumor size was 10 mm (range: 7-12). The lesion locations were the head (n=1), body (n=2), and tail (n=2). The median distance from the main pancreatic duct was 2.5 mm (range: 2.0-2.5), indicating that only cases with a sufficient distance were included.

Informed consent was obtained from six patients; however, one case was not enrolled in the study because a definitive diagnosis of pancreatic neuroendocrine neoplasm (NEN) could not be made by EUS-FNA during the screening examination. As a result, five patients were enrolled and underwent the treatment. Some patients were referred specifically for this treatment, and enrollment progressed more smoothly than initially expected. Consequently, the study was completed approximately one year earlier than originally planned. According to the study protocol, all five participants were followed up for six months after the treatment, with all patients visiting as scheduled, allowing follow-up to be completed. Planned number of cases: 5, Number of patients who provided consent: 6, Number of patients treated: 5 (Number of cases completed: 5, Number of cases discontinued: 0)

Mild acute pancreatitis occurred in one case, and pancreatic pseudocysts developed in two cases (one case overlapped). The acute pancreatitis improved with conservative treatment, and the patient was discharged after a two-day extension of hospitalization. The pancreatic pseudocysts were detected on CT one month after treatment, and both cases were asymptomatic. Therefore, they were managed with observation. By six months after treatment, the pseudocysts showed a tendency to shrink, suggesting a high likelihood of spontaneous resolution, and further follow-up was deemed unnecessary. There were no severe adverse events in this study.

The primary endpoint of this study was safety. Procedure-related adverse events were assessed based on the criteria of the ASGE Workshop 2010, with events classified as moderate or more severe defined as serious adverse events. No serious adverse events occurred, and the incidence of adverse events during the study period was 40% (2 out of 5 cases). For the secondary endpoint of efficacy, it was defined as the complete disappearance of contrast enhancement in the tumor on contrast-enhanced CT. Evaluation was performed using 1-2 mm slice images in the arterial phase, and two diagnostic physicians with expertise in pancreatobiliary diseases (excluding the treatment operator) made the final judgment through discussion. At both one and six months after treatment, tumor ablation was successful in all cases, with an efficacy rate of 100% (5/5). Regarding treatment procedure details, the median tumor size was 10 mm (range: 7-12), with lesion locations in the head (n=1), body (n=2), and tail (n=2) of the pancreas. The median distance from the main pancreatic duct was 2.5 mm (range: 2.0-2.5). The median procedure time was 16 minutes (range: 9-21). Ablation settings included 10 W for 25 seconds in one case, 20 W for 20, 40, and 97 seconds in three cases, and 30 W for 67 seconds in one case. No intraoperative complications were observed. The number of total ablation sessions per procedure was once in three cases and three times in two cases. The median hospitalization period was 5 days (range: 5-7). Device-related malfunctions were not observed in any cases, and there were no occurrences or exacerbations of diabetes mellitus. All patients were alive at 6 months post-treatment, with a 6-month survival rate of 100% (5/5).

EUS-RFA for PNENs less than or equal to 15 mm demonstrated a high complete ablation rate without severe complications, suggesting its potential as a minimally invasive treatment for small, low-grade PNENs. Further studies with a larger number of cases are needed.

July. 08, 2025

Jan. 22, 2025

https://pubmed.ncbi.nlm.nih.gov/39885893/

No

none

https://jrct.mhlw.go.jp/latest-detail/jRCTs062230014

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

Complete

May. 12, 2023

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

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

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

Both

Pancreatic neuroendocrine neoplasms

Radiofrequency ablation for tumor under EUS-guidance

Safety

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

+81-86-235-7133

April. 25, 2023

none