A Phase 1/2 interventional study of Pancreatectomy and Quality-of-Life Assessment in Benign Pancreatic Neoplasm, Chronic Pancreatitis and Recurrent Acute Pancreatitis, sponsored by OHSU Knight Cancer Institute. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-25.
Sponsored by OHSU Knight Cancer Institute · Phase 1/2, Interventional, and Treatment
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.
PRIMARY OBJECTIVE:
I. To evaluate the oncologic safety of total pancreatectomy with islet cell autotransplantation (TPIAT) in chronic pancreatitis patients with benign pancreatic neoplasms.
SECONDARY OBJECTIVES:
I. To evaluate postoperative insulin requirements in patients with presumed benign pancreatic neoplasms undergoing TPIAT.
II. To evaluate postoperative opiate requirements in patients with presumed benign pancreatic neoplasms undergoing TPIAT.
III. To evaluate the postoperative survival of patients with presumed benign pancreatic neoplasms undergoing TPIAT.
EXPLORATORY OBJECTIVES:
I. To evaluate quality of life outcomes in patients undergoing TPIAT with presumed benign pancreatic neoplasms.
II. To evaluate subjective pain-related outcomes in patients undergoing TPIAT with presumed benign pancreatic neoplasms.
OUTLINE:
Patients undergo total pancreatectomy and autologous islet cell transplant intravenously (IV) over 15-60 minutes on day 1.
After completion of study treatment, patients are followed up for 2 years.
264 studies on the registry are indexed under Pancreatitis, Chronic; 73 are open to participants now.
This study's planned enrollment of 12 is below the median of 46 across 140 interventional studies indexed under Pancreatitis, Chronic.
Browse Pancreatitis, Chronic studies →OHSU Knight Cancer Institute is the lead sponsor of 242 studies on the registry; 45 are open to participants now.
Of its 27 completed or terminated interventional studies of FDA-regulated products, 15 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
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
Chronic abdominal pain of > 6-month duration with at least one of the following:
At least two of the following:
At least one of the following:
Exclusion Criteria:
Underlying liver disease, unless participant has undergone hepatology consultation to evaluate hepatic risk from IAT and been deemed low-risk, including:
Cirrhosis, defined by either
A pancreatic neoplasm deemed to be at high risk for harboring occult malignancy as assessed by the multi-disciplinary pancreas tumor board and multi-disciplinary chronic pancreatitis conference after comprehensive evaluation of relevant clinical, radiographic, pathologic, and serologic data. Features of high-risk neoplasms include the following, however the below items are not to be taken as absolute contraindications to TPIAT:
Evidence of metabolic syndrome, as defined by any 3 of the below features, unless the participant has undergone hepatology consultation to evaluate hepatic risk from IAT and been deemed low-risk:
Patients undergo total pancreatectomy and autologous islet cell transplant IV over 15-60 minutes on day 1.
Procedure: Pancreatectomy · Other: Quality-of-Life Assessment · Other: Treatment Planning
Undergo pancreatectomy
Also known as: Excision of the Pancreas, Pancreas Excision
Ancillary studies
Also known as: Quality of Life Assessment
Undergo 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.
Time frame: From date of surgery to time of identification of metastatic disease from a pancreatic primary, assessed up to 2 years post-surgery or date of death due to metastatic disease of a pancreatic origin
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.
Time frame: From date of surgery to 2 years post-surgery or death by any cause
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 frame: From date of surgery to 2 years post-surgery or death by any cause
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.
Time frame: From date of surgery to 2 years post-surgery or death by any cause
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.
Time frame: Up to 2 years
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.
Time frame: Up to 2 years
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.
Time frame: Up to 2 years
This study is not yet recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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OHSU Knight Cancer Institute