Chronic pancreatitis or obstructive pancreatitis with pain Chronic pancreatitis obstructive pancreatitis
Conditions
Interventions
Sponsors
masayuki shimoda
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age is between 20 and 70 years old. 2. A written consent can be obtained. 3. The protocol procedures in this clinical trial can be followed. 4. Diagnosed as chronic pancreatitis or obstructive pancreatitis. 5. Pain due to chronic pancreatitis or obstructive pancreatitis. 6. Previous conservative treatment, celiac plexus block, endoscopic pancreatic duct decompression / opening, endopancreatic stenting 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. Untreated retinopathy 6. Systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg 7. eGFR 1g / day 9. Pregnancy or breastfeeding 10. Active infections: Hepatitis B, hepatitis C, HIV infection, HTLVI infection or mycobacteriosis including tuberculosis. 11. Pulmonary fibrosis 12. Malignant tumor. 13. Alcoholism or drug dependency 14. Anemia, lymphopenia (<700 / uL), neutropenia (<1,500 / uL), or thrombocytopenia (platelets <100,000 / uL) . 15. Coagulopathy 16. Severe heart disease 17. Liver dysfunction 18. Portal vein hypertension or liver fibrosis 19. Symptomatic cholelithiasis 20. Peptic ulcer 21. Gastrointestinal disorders with impair oral drug absorption 22. Participant in another clinical trial 23. Patients who are unable to make regular outpatient visits 24. Mental illness 25. Patients who are judged to be inappropriate by clinical trial investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| At 1 year after the treatment (365 days), The percentage of patients who improve the pancreatic pain (Izbicki pain score decreased by more than 50% from the preoperative value) and do not experience severe hypoglycema event and have good glycemic control. Good glycemic control is defined as HbA1c value (NGSP value) <7.4%, or HbA1c value (NGSP value) is less than preoperative value plus 1.0% if the patient was originally diabetic, and no severe hypoglycemia occur between 30 days and 1 year. | — |
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) Evaluation of QOL by SF36 and QLQPAN28 (CP) 5) Pain score by numerical rating scale (average of last 7 days) 6) Body weight 7) Fat stool 8) Pancreatic exocrine function 9) Dosage of digestive enzymes 10) Percentage of insulin depencent cases 11) Reduction rate of required insulin amount compared to pre-treatement (applicable cases only) 12) HbA1c value (NGSP value) 13) Ryan hypoglycemia severity (HYPO) score 14) Fasting blood glucose level and C-peptide level 15) stimulated serum C-peptide level 16) Beta-score 17) SUITO Index 18) OGTT 120 minutes value 19) Insulinogenic Index value 20) Presence of hypoglycemia unawareness 21) Presence of severe hypoglycema 22) Adverse event rate | — |
Countries
Japan, none
Contacts
Public ContactMiyuki Tsuchida
National Center for Global Health and Medicine
Outcome results
None listed