Clinical Study of Pancreatectomy with Autologous Islet Transplantation for Treatment of Chronic Pancreatitis

Phase 2

• Conditions: Chronic pancreatitis or obstructive pancreatitis with pain; Chronic pancreatitis obstructive pancreatitis

• Registration Number: JPRN-jRCTc030190233
• Lead Sponsor: masayuki shimoda

Brief Summary

We enrolled 5 patients with chronic pancreatitis who were indicated and consented. All patients underwent protocol treatment (total pancreatectomy + autologous islet transplantation). One year of observation was performed and evaluated. Key endpoints were achieved in 4 cases (80%). Multiple adverse events requiring hospitalization occurred, but all recovered. There were no serious adverse events associated with autologous islet transplantation.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-02
• Study Completion: 2020-06-26
• Results First Posted: 2021-07-29
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 5

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

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 < 60ml / min / 1.73m2 8. Urine protein > 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.