Chronic pancreatitis and pancreatic arteriovenous malformation Chronic pancreatitis and pancreatic arteriovenous malformation
Conditions
Interventions
Sponsors
Shimoda Masayuki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 1) Percentage of patients with improved pancreatic pain (Izbicki pain score lower than preoperative value or Pain score lower than preoperative value) 2) Percentage of patients with good glycemic control without severe hypoglycemia. 3) Percentage of patients who do not need analgesics 4) Types and doses of analgesics 5) Evaluation of QOL by SF36 and QLQPAN28 (CP) 6) Pain score by numerical rating scale (average of last 7 days) 7) Body weight and BMI 8) Dosage of digestive enzymes 9) Percentage of insulin depencent cases 10) Insulin dose 11) HbA1c value (NGSP value) 12) Fasting blood glucose level and C-peptide level 13) stimulated serum C-peptide and glucagon level 14) beta-score 15 SUITO Index 16) OGTT 120 minutes value 17) Insulinogenic Index value 18) Presence of hypoglycemia unawareness 19) Presence of severe hypoglycema 20) Nutritional evaluation (serum total protein, albumin, prealbumin, total cholesterol, transferrin, retinol binding protein, vitamin E, hand grip strength) 21) Proportion of secondary registration cases among primary registration cases Adverse event rate | — |
Countries
Japan
Contacts
Public ContactYuki Kuroda
National Center for Global Health and Medicine
Outcome results
None listed