Clinical trial for advanced medical care aiming at the coverage of National Health Insurance of islet autotransplantation following pancreatectomy for chronic pancreatitis

Abstract

Surgical treatment such as pancreatectomy is used for painful and refractory chronic pancreatitis. However, pancreatectomy, especially total pancreatectomy, is highly invasive because it involves loss of pancreatic endocrine function. Therefore, an islet autotransplantation has been developed to maintain endogenous islet function by transplanting islets isolated from the excised pancreas into the patient’s own liver. Total pancreatectomy with islet autotransplantation (TPIAT) is indicated in cases of chronic pancreatitis with non-dilated pancreatic ducts, hereditary pancreatitis, or in cases where previous treatment is ineffective. In Europe and the United States, TPIAT has become a treatment option and a standard of care in the United States. However, the number of TPIATs is limited in Asia, including Japan, and autologous islet transplantation is not covered by public insurance in Japan. Therefore, the authors have initiated a multi-institutional clinical trial for advanced medical care with the aim of making this treatment covered by public insurance in Japan.