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Procedure

Pancreatectomy + Islet Transplant for Benign Pancreatic Conditions

Phase 1 & 2
Waitlist Available
Led By Brett C Sheppard
Research Sponsored by OHSU Knight Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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, 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
Be older than 18 years old
Must not have
Prior allogenic or autologous islet cell transplantation
Cytology or biopsy of a pancreatic neoplasm diagnostic for malignancy prior to the time of IAT
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a surgery to remove the pancreas and transplant the cells that produce insulin, to treat people with chronic pancreatitis or benign pancreatic tumors.

Who is the study for?
This trial is for adults with chronic pancreatitis or benign pancreatic tumors who need their pancreas removed but want to avoid diabetes. They must not have diabetes, be able to consent, and have no untreated cancers or liver disease. Pregnant individuals and those using alcohol or tobacco recently are excluded.
What is being tested?
The safety and effectiveness of total pancreatectomy combined with islet cell autotransplantation are being tested. This procedure aims to prevent diabetes after the removal of the pancreas by transplanting the patient's own insulin-producing cells into their liver.
What are the potential side effects?
Potential side effects include risks associated with major surgery such as infection, bleeding, blood clots, and anesthesia complications. There may also be a risk of developing diabetes if not all insulin-producing cells function after transplantation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
Criterion: You have chronic pancreatitis-related pain and meet specific criteria for surgery. You also need to meet certain health requirements like having a good performance status, life expectancy of more than 2 years, and not having certain active infections. If you are of reproductive age, you need to use birth control before the surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had a previous islet cell transplant.
Select...
My pancreatic tumor was confirmed malignant before therapy.
Select...
I am not pregnant, as the study involves risky abdominal surgery.
Select...
I have a cancer that started in a part of my body other than the pancreas and it has not been treated.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of patients that are free of metastatic disease to the liver from a pancreatic primary
Secondary study objectives
Insulin free rate
Opiates free rate
Time to overall survival (OS)
Other study objectives
Incidence of adverse events (AEs)
Pain
Quality of life (QOL)

Side effects data

From 2022 Phase 2 trial • 147 Patients • NCT02562716
84%
Fatigue
82%
Anemia
69%
Neutrophil count decreased
64%
Nausea
64%
Diarrhea
60%
Platelet count decreased
53%
White blood cell decreased
49%
Anorexia
49%
Abdominal pain
42%
Alopecia
42%
Hypokalemia
42%
Peripheral sensory neuropathy
40%
Hypoalbuminemia
38%
Alanine aminotransferase increased
38%
Aspartate aminotransferase increased
36%
Constipation
36%
Vomiting
36%
Alkaline phosphatase increased
31%
Fever
31%
Hyperglycemia
31%
Myalgia
29%
Pain
29%
Hyponatremia
27%
Insomnia
24%
Weight loss
24%
Hypocalcemia
24%
Depression
24%
Hypertension
22%
Dyspnea
22%
Edema limbs
20%
Chills
18%
Flu like symptoms
18%
Blood bilirubin increased
18%
Cough
18%
Dysgeusia
18%
Headache
18%
Hypotension
16%
Dehydration
16%
Lymphocyte count decreased
16%
Dyspepsia
16%
Creatinine increased
16%
Anxiety
16%
Back pain
16%
Rash maculo-papular
13%
Bloating
13%
Mucositis oral
13%
Sinus tachycardia
13%
Arthralgia
13%
Generalized muscle weakness
13%
Dizziness
11%
Epistaxis
11%
Pruritus
11%
Gastrointestinal disorders-Other
11%
Hypomagnesemia
9%
Sepsis
9%
Malaise
9%
Skin infection
9%
Sore throat
9%
Eye disorders-Other
9%
Lung infection
9%
Wound infection
9%
Bone pain
7%
Investigations-Other
7%
Productive cough
7%
Eye pain
7%
Flatulence
7%
Abdominal distension
7%
Thromboembolic event
7%
Dry mouth
7%
Hyperkalemia
7%
Metabolism and nutrition disorders - Other, specify
7%
Pain in extremity
7%
Peripheral motor neuropathy
7%
Skin and subcutaneous tissue disorders - Other
7%
Hot flashes
7%
Gastroparesis
4%
Cholecystitis
4%
Upper respiratory infection
4%
Respiratory failure
4%
General disorders and admin site conditions - Other
4%
INR increased
4%
Pancreatic enzymes decreased
4%
Genital edema
4%
Vascular disorders-Other
4%
Gastritis
4%
Infections and infestations-Other
4%
Pain of skin
4%
Sinus bradycardia
4%
Gastrointestinal fistula
4%
Febrile neutropenia
4%
Biliary tract infection
4%
Bruising
4%
Urinary frequency
4%
Nasal congestion
4%
Rash acneiform
4%
Localized edema
2%
Sinusitis
2%
Atelectasis
2%
Bile duct stenosis
2%
Scrotal pain
2%
Infusion related reaction
2%
Gum infection
2%
Pleural infection
2%
Gastric anastomotic leak
2%
Glucose intolerance
2%
Hypercalcemia
2%
Hypophosphatemia
2%
Confusion
2%
Delirium
2%
Hoarseness
2%
Sinus disorder
2%
Dry skin
2%
Non-cardiac chest pain
2%
Enterocolitis infectious
2%
Lipase increased
2%
Weight gain
2%
Resp, thoracic and mediastinal disorders - Other
2%
Gastric hemorrhage
2%
Gastroesophageal reflux disease
2%
Hemorrhoids
2%
Ileus
2%
Oral pain
2%
Papulopustular rash
2%
Postoperative hemorrhage
2%
Spasticity
2%
Vasovagal reaction
2%
Hiccups
2%
Hyperhidrosis
2%
Nail discoloration
2%
Cardiac arrest
2%
Ventricular tachycardia
2%
Chest pain - cardiac
2%
Tinnitus
2%
Duodenal ulcer
2%
Dysphagia
2%
Leukocytosis
2%
Supraventricular tachycardia
2%
Ventricular fibrillation
2%
Hearing impaired
2%
Dry eye
2%
Pancreatic fistula
2%
Pancreatitis
2%
Rectal hemorrhage
2%
Abdominal infection
2%
Bronchial infection
2%
Catheter related infection
2%
Biliary anastomotic leak
2%
Fall
2%
Urinary tract infection
2%
Wound complication
2%
Hypernatremia
2%
Hypertriglyceridemia
2%
Hypoglycemia
2%
Arthritis
2%
Flank pain
2%
Muscle weakness lower limb
2%
Dysesthesia
2%
Lethargy
2%
Nervous system disorders-Other
2%
Sinus pain
2%
Somnolence
2%
Hallucinations
2%
Restlessness
2%
Acute kidney injury
2%
Hematuria
2%
Urine discoloration
2%
Hypoxia
2%
Pleural effusion
2%
Pneumonitis
2%
Postnasal drip
2%
Flushing
2%
Superficial thrombophlebitis
2%
Colonic perforation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Gem/Nab-P->Surg->Gem/Nab-P
mFOLFIRINOX->Surg->mFOLFIRINOX

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (pancreatectomy, autologous islet cell transplant)Experimental Treatment3 Interventions
Patients undergo total pancreatectomy and autologous islet cell transplant IV over 15-60 minutes on day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pancreatectomy
2012
Completed Phase 2
~160

Find a Location

Who is running the clinical trial?

OHSU Knight Cancer InstituteLead Sponsor
236 Previous Clinical Trials
2,089,568 Total Patients Enrolled
Oregon Health and Science UniversityOTHER
1,006 Previous Clinical Trials
7,413,960 Total Patients Enrolled
Brett C SheppardPrincipal InvestigatorOHSU Knight Cancer Institute

Media Library

Total Pancreatectomy (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05453851 — Phase 1 & 2
Benign Pancreatic Tumor Research Study Groups: Treatment (pancreatectomy, autologous islet cell transplant)
Benign Pancreatic Tumor Clinical Trial 2023: Total Pancreatectomy Highlights & Side Effects. Trial Name: NCT05453851 — Phase 1 & 2
Total Pancreatectomy (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05453851 — Phase 1 & 2
~8 spots leftby Jul 2029
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