A Study of Pancreatectomy with Autologous Islet Transplantation for Treatment of Chronic Pancreatitis
- Conditions
- Chronic pancreatitis and pancreatic arteriovenous malformation
- Registration Number
- JPRN-jRCTc030220161
- Lead Sponsor
- Shimoda Masayuki
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 10
1. A written consent can be obtained. 2. Age is between 18 and 70 years old. 3. Diagnosis of chronic pancreatitis or pancreatic arteriovenous malformation 4.Previous conservative treatment, celiac plexus block, endoscopic treatment or surgical treatment were ineffective.
1. BW >100kg or BMI >30 kg/m2. 2. Insulin requirement >0.8IU/kg/day or >55U/day. 3. Type 1 diabetes. 4. HbA1c>10%. 5. Systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg. 6. eGFR >30ml/min/1.73m2. 7. Pregnancy or breastfeeding. 8. Active infections, Hepatitis B, hepatitis C or mycobacteriosis including tuberculosis. 9. Malignant tumor. However, those who have been diagnosed as recurrence-free after treatment are not excluded. 10. Alcoholism or drug dependency 11. Hb<10 g/dL. However, this does not exclude cases where blood transfusion is planned during surgery. 12. Coagulopathy. 13. Severe heart disease. 14. Liver dysfunction. 15. Portal vein hypertension or liver fibrosis. 16. Pancreatic tumor. 17. Gastrointestinal disorders with impair oral drug absorption. 18. Participant in another clinical trial. 19. Patients who are unable to make regular outpatient visits. 20. Mental illness. 21. Patients who are judged to be inappropriate by clinical trial investigators.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The ratio of patients with good glycemic control 6 months after treatment (180 +/- 14 days). blood glucose control is defined as satisfying all of the following 1, 2 and 3. 1. Fasting blood c-peptide >= 0.1 ng / mL. 2. HbA1c value <7.4% or HbA1c value <preoperative value + 1.0% in case of diabetes before treatment 3. No severe hypoglycemic attack from 30 days to 6 months after treatment
- Secondary Outcome Measures
Name Time Method