A Surgical Procedure (Total Pancreatectomy) With a Transplant Procedure (Islet Cell Autotransplantation) for the Treatment of Chronic Pancreatitis and Benign Pancreatic Tumors

NCT05453851 | Not Yet Recruiting Phase 1 FDA Drug

• 2 other identifiers: STUDY00023937NCI-2022-05134
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Benign Pancreatic Neoplasm; Chronic Pancreatitis; Recurrent Acute Pancreatitis

Outcome Measures

Primary Outcomes (1)

• 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.

  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

Secondary Outcomes (3)

• Insulin free rate

  From date of surgery to 2 years post-surgery or death by any cause

• Opiates free rate

  From date of surgery to 2 years post-surgery or death by any cause

• Time to overall survival (OS)

  From date of surgery to 2 years post-surgery or death by any cause

Other Outcomes (3)

• Quality of life (QOL)

  Up to 2 years

• Pain-related outcomes

  Up to 2 years

• Incidence of adverse events (AEs)

  Up to 2 years

Study Arms (1)

Treatment (pancreatectomy, autologous islet cell transplant)

EXPERIMENTAL

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

Interventions

Pancreatectomy PROCEDURE

Undergo pancreatectomy

Also known as: Excision of the Pancreas, Pancreas Excision

Treatment (pancreatectomy, autologous islet cell transplant)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Treatment (pancreatectomy, autologous islet cell transplant)

Treatment Planning OTHER

Undergo IV autologous islet cell transplant

Treatment (pancreatectomy, autologous islet cell transplant)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Chronic abdominal pain of \> 6-month duration with at least one of the following:
• Pancreatic calcification on computed tomography (CT) scan
• At least two of the following:
• Definite of suggestive diagnosis of chronic pancreatitis on endoscopic ultrasound
• Ductal or parenchymal abnormalities compatible with chronic pancreatitis on secretin magnetic resonance cholangiopancreatography
• Abnormal endoscopic pancreatic function tests (peak HCO2 \< 80mM)
• Histopathology confirmed diagnosis of chronic pancreatitis
• Compatible clinical history and documented hereditary pancreatitis gene mutation OR
• History of recurrent acute pancreatitis (more than one episode of characteristic pain associated with imaging diagnostic of acute pancreatitis and/or elevated serum amylase or lipase \> 3 times upper limit of normal
• At least one of the following:
• Daily narcotic dependence

You may not qualify if:

• 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
• Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
• Patients with a prior or active non-pancreatic malignancy are eligible for this trial
• Invasive abdominal surgical procedures such as pancreatectomy have the known potential to cause pregnancy loss. For this reason, persons of reproductive potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to undergoing pancreatectomy and IAT. Should a participant become pregnant or suspect a pregnancy prior to planned pancreatectomy and IAT, the participant should inform their treating physician immediately
• Prior allogenic or autologous islet cell transplantation
• 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
• Pathologic diagnosis of cirrhosis OR
• Diagnosis of cirrhosis by hepatology following evaluation prompted by clinical, radiographic, or biochemical evidence of cirrhosis
• Hepatic steatosis as defined by pathologic examination of the liver or liver magnetic resonance imaging in the absence of pathologic evidence
• Use of any systemically absorbed steroid (e.g., prednisone but not budesonide) within the prior month
• Untreated malignancy of a non-pancreatic primary

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• Oregon Health and Science University: collaborator

Study Sites (1)

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Pancreatitis, Chronic; Pancreatitis

Interventions

Pancreatectomy

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Brett C Sheppard

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brett C Sheppard, MD

CONTACT

503-494-4373; sheppard@ohsu.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 7, 2022
• First Posted: July 12, 2022
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): July 1, 2030
• Last Updated: November 25, 2025

Record last verified: 2025-11

Locations

US (1)