This phase I/II trial assesses the safety and effectiveness of total pancreatectomy with islet cell autotransplantation for the treatment of patients with long-term pancreatic inflammation (chronic pancreatitis) and non-cancerous (benign) pancreatic tumors. Total removal of the pancreas (pancreatectomy) can be used to treat chronic pancreatitis, but it may result in diabetes. An islet cell autotransplantation involves removing cells from a patient's pancreas (the islet cells) and infusing them into the liver. Islet cells are responsible for producing hormones like insulin, reducing the occurrence of diabetes in patients undergoing total pancreatectomy. Total pancreatectomy with autologous islet cell transplant is an accepted and Food and Drug Administration-approved treatment for patients with chronic pancreatitis. However, patients with chronic pancreatitis and pancreatic tumors have historically not been candidates for this procedure due to concerns of spreading potentially cancerous cells to other parts of the body. This clinical trial evaluates the safety and effectiveness of this treatment in patients with chronic pancreatitis and benign pancreatic tumors.
Participant or legally authorized representative (LAR) must provide written informed consent before any study-specific procedures or interventions are performed
Age>= 18 years. Both men and women and members of all races and ethnic groups will be included. Gender-nonconforming and gender-fluid individuals as members of the general population will also be included
Participants must have adequate islet cell function (non-diabetic or C-peptide positive)
Participants must be indicated for total surgical resection of the pancreas for chronic pancreatitis-associated pain meeting eligibility criteria for TPIAT per University of Minnesota Criteria as defined by all of the following
Eastern Cooperative Oncology Group (ECOG) performance status =< 1
Life expectancy of greater than 2 years
Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
Single group
Pancreatectomy
Procedure/SurgeryUndergo pancreatectomy
Quality-of-Life Assessment
Other interventionAncillary studies
Treatment Planning
Other interventionUndergo IV autologous islet cell transplant
Proportion of patients that are free of metastatic disease to the liver from a pancreatic primary
The 95% confidence interval (CI) will be analyzed using the Clopper-Pearson exact interval method.
Insulin free rate
Defined as proportion not requiring insulin for blood glucose control for at least 14 days prior to the assessment date at 2 years. The 95% CI will be analyzed using Clopper-Pearson exact interval method.
Opiates free rate
Defined as proportion not receiving opiates for at least 14 days prior to the assessment date at 2 years.The 95% CI will be analyzed using Clopper-Pearson exact interval method.
Time to overall survival (OS)
The time to OS distribution will be characterized using the Kaplan-Meier method. Kaplan-Meier curves of OS rate at 2 years will be estimated from the survival curve along with the 95% CI.
Quality of life (QOL)
QOL scores will be collected over time using the Short Form 12. Summary of QOL and its change over time will be presented graphically using box plot and spaghetti plots, in addition to a summary table of QOL over time.
Pain-related outcomes
Subjective pain-related outcomes will be collected using Patient Reported Outcomes Measurement Information System Bank Pain Interference Survey, version 1.1 and will be analyzed similar to the QOL survey.
Incidence of adverse events (AEs)
AEs of grade 3 or greater will be collected and tabulated by the Medical Dictionary for Regulatory Activities version 21.1. By-patient listings will also be provided for the following: patient deaths, serious adverse events, and AEs leading to withdrawal.
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OHSU Knight Cancer Institute
Lead sponsor
Oregon Health and Science University
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
