Ethanol injection therapy for patients with pancreatic neuroendocrine neoplasm

Study of endoscopic ultrasonography-guided ethanol injection therapy for patients with pancreatic neuroendocrine neoplasm

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs061200016

Enrollment

Registered

2020-09-30

Start date

2020-11-13

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pancreatic neuroendocrine neoplasm

Interventions

Injection of ethanol into the tumor under EUS-guidance

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. 20 to 75 years old of age 2. Patient who have been fully informed consent. 3. PNEN of which grade was G1 confirmed pathologically by EUS-FNA specimen(WHO 2017 classification) 4. Not less than 15 mm of tumor size and well enhanced tumor at the arterial phase on CE-CT 5. non-functionnal PNEN or insulinoma

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
The percentage of subjects (not less than 15mm of tumor size) who achieved all of the following points. 1. Efficacy: Complete ablation rate at 1 and 6 months, respectively 2. Safety: Avoidance of severe adverse event within 1 month Avoidance of severe pancreatic fistula at 1 month later Avoidance of the incidence and exacerbation of diabetes mellitus 6 months later	—

Secondary

Measure	Time frame
To evaluate following points in each cohort. Cohort 1: Not more than 10mm of tumor size Cohort 2: 10 to 15mm of tumor size Safety: 1. Rate of total adverse event 2. Failure rate of procedure equipment 3. Rate of requiring conversion to surgery 4. Severe adverse event within 1 month 5. Rate of severe pancreatic fistula at 1 month later 6. Incidence of diabetes mellitus 6 months later. Efficacy: 1. Complete ablation rate at 1 month. 2. Complete ablation rate at 6 month 3. 6 month survival Only for patients diagnosed insulinoma 1. Improvement of hypoglycemia 2 Changes of serum levels of fasting blood glucose, insulin, and C peptide pre and post procedure	—

Measure

Time frame

To evaluate following points in each cohort. Cohort 1: Not more than 10mm of tumor size Cohort 2: 10 to 15mm of tumor size Safety: 1. Rate of total adverse event 2. Failure rate of procedure equipment 3. Rate of requiring conversion to surgery 4. Severe adverse event within 1 month 5. Rate of severe pancreatic fistula at 1 month later 6. Incidence of diabetes mellitus 6 months later. Efficacy: 1. Complete ablation rate at 1 month. 2. Complete ablation rate at 6 month 3. 6 month survival Only for patients diagnosed insulinoma 1. Improvement of hypoglycemia 2 Changes of serum levels of fasting blood glucose, insulin, and C peptide pre and post procedure

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Contacts

Public ContactKazuyuki Matsumoto

Okayama University Hospital

katou-h@cc.okayama-u.ac.jp+81-86-235-7219

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026