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

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Brief Title

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

Official Title

Total Pancreatectomy With Islet Cell Autotransplantation in Patients With Benign Pancreatic Neoplasms: A Pilot Study

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.

Detailed Description


      I. To evaluate the oncologic safety of total pancreatectomy with islet cell
      autotransplantation (TPIAT) in chronic pancreatitis patients with benign pancreatic


      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.


      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.


      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.

Study Phase

Phase 1/Phase 2

Study Type


Primary Outcome

Proportion of patients that are free of metastatic disease to the liver from a pancreatic primary

Secondary Outcome

 Insulin free rate


Benign Pancreatic Neoplasm



Study Arms / Comparison Groups

 Treatment (pancreatectomy, autologous islet cell transplant)
Description:  Patients undergo total pancreatectomy and autologous islet cell transplant IV over 15-60 minutes on day 1.


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status


Estimated Enrollment


Start Date

November 1, 2022

Completion Date

November 1, 2029

Primary Completion Date

November 1, 2027

Eligibility Criteria

        Inclusion Criteria:

          -  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

          -  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

                         -  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

                    -  Pain resulting in impaired quality of life, which may include: inability to
                       attend school, recurrent hospitalizations, or inability to participate in
                       usual, age-appropriate activities.

               -  Complete evaluation with no reversible cause of pancreatitis present or untreated

               -  Failure to respond to maximal medical and endoscopic therapy

          -  If clinical, radiologic, or biochemical evidence suggestive of cirrhosis or metabolic
             syndrome (defined in exclusion criteria), the participant has undergone hepatology
             evaluation and been exonerated of a cirrhosis diagnosis or otherwise deemed to be at
             low hepatic risk from IAT

          -  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

        Exclusion Criteria:

          -  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

          -  Cytology or biopsy of a pancreatic neoplasm diagnostic for malignancy prior to the
             time of IAT

          -  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:

               -  Obstructive jaundice in a patient with a pancreatic cystic neoplasm in the head
                  of the pancreas

               -  Enhancing mural nodule of any size

               -  Main pancreatic duct >= 5mm

               -  Acute pancreatitis with cystic lesion as the only potentially identifiable cause

               -  Cyst >= 3cm, if lesion is a mucinous neoplasm

               -  Thickened/enhancing cyst walls

               -  Abrupt change in caliber of pancreatic duct with distal pancreatic atrophy on

               -  Celiac/portal lymphadenopathy

               -  Serum CA19-9 above the institutional upper limit of normal

               -  Pancreatic cyst growth rate >= 5mm every 2 years

               -  Cytology suspicious for malignancy

               -  Clinical suspicion for main duct involvement based on imaging

          -  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:

               -  Waist circumference more than 40 inches in men and 35 inches in women

               -  Elevated triglycerides 150 milligrams per deciliter of blood (mg/dL) or greater

               -  Reduced high-density lipoprotein cholesterol (HDL) less than 40 mg/dL in men or
                  less than 50 mg/dL in women

               -  Elevated fasting glucose of 100 mg/dL or greater

               -  Blood pressure values of systolic 130 mmHg or higher and/or diastolic 85 mmHg or

          -  Multifocal or large pancreatic neoplasms such that an insufficient volume of remnant
             pancreas would remain for the patient to benefit from IAT following resection of the
             neoplasms in the opinion of the multi-disciplinary chronic pancreatitis board

          -  History of allergic reaction to human albumin preparations

          -  Demonstrated medical non-compliance

          -  Patient unsafe to undergo the required pancreatectomy procedure in the opinion of the
             attending surgeon and/or anesthesiologist

          -  Patients deemed not suitable for the IAT follow-up protocol by any member of the
             multi-disciplinary IAT care team

          -  Any alcohol or tobacco use within 6 months of study enrollment

          -  Financial, logistic, or insurance constraints preventing adequate and timely
             pre-operative evaluation, case scheduling, or post-operative monitoring/follow-up

          -  Pregnant individuals are excluded from this study because invasive abdominal surgical
             procedures such as pancreatectomy have the known potential to cause pregnancy loss




18 Years - N/A

Accepts Healthy Volunteers



Brett C Sheppard, , 

Location Countries

United States

Location Countries

United States

Administrative Informations



Organization ID


Secondary IDs


Responsible Party

Principal Investigator

Study Sponsor

OHSU Knight Cancer Institute


 Oregon Health and Science University

Study Sponsor

Brett C Sheppard, Principal Investigator, OHSU Knight Cancer Institute

Verification Date

July 2022