JPRN-jRCTc030190233已完成2 期
Clinical Study of Pancreatectomy with Autologous Islet Transplantation for Treatment of Chronic Pancreatitis - PAITTCP
masayuki shimoda0 个研究点目标入组 5 人开始时间: 2020年3月2日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 5
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 70age old（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
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