Ethanol injection therapy for patients with pancreatic neuroendocrine neoplasm

JRCT ID: jRCTs061200016

Registered date:30/09/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: pancreatic neuroendocrine neoplasm
• Date of first enrollment: 13/11/2020
• Target sample size: 25
• Study type: Interventional
• Intervention(s): Injection of ethanol into the tumor under EUS-guidance

Outcome(s)

Primary Outcome

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 Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 75age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Kato Hironari