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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
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 • NCT0256271684%
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%
Creatinine increased
16%
Dyspepsia
16%
Anxiety
16%
Dehydration
16%
Lymphocyte count decreased
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%
Lung infection
9%
Eye disorders-Other
9%
Sepsis
9%
Malaise
9%
Skin infection
9%
Sore throat
9%
Wound infection
9%
Bone pain
7%
Thromboembolic event
7%
Flatulence
7%
Investigations-Other
7%
Productive cough
7%
Eye pain
7%
Abdominal distension
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%
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%
Cholecystitis
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%
Papulopustular rash
2%
Spasticity
2%
Vasovagal reaction
2%
Hypophosphatemia
2%
Hiccups
2%
Bile duct stenosis
2%
Scrotal pain
2%
Oral pain
2%
Gum infection
2%
Pleural infection
2%
Gastric anastomotic leak
2%
Glucose intolerance
2%
Hypercalcemia
2%
Confusion
2%
Delirium
2%
Hoarseness
2%
Sinus disorder
2%
Dry skin
2%
Non-cardiac chest pain
2%
Enterocolitis infectious
2%
Lipase increased
2%
Atelectasis
2%
Infusion related reaction
2%
Weight gain
2%
Gastric hemorrhage
2%
Gastroesophageal reflux disease
2%
Resp, thoracic and mediastinal disorders - Other
2%
Hemorrhoids
2%
Ileus
2%
Postoperative hemorrhage
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
2,089,560 Total Patients Enrolled
Oregon Health and Science UniversityOTHER
1,008 Previous Clinical Trials
7,414,177 Total Patients Enrolled
Brett C SheppardPrincipal InvestigatorOHSU Knight Cancer Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a previous islet cell transplant.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.My pancreatic cancer is too widespread for surgery to leave enough healthy pancreas.My pancreatic tumor was confirmed malignant before therapy.You have had an allergic reaction to human albumin in the past.I am 18 years or older and understand people of any gender and race can join.You have not followed medical instructions in the past.I meet at least three criteria for metabolic syndrome or have been cleared by a hepatologist.I am not pregnant, as the study involves risky abdominal surgery.I have liver disease but have been deemed low-risk by a hepatologist.My surgeon or anesthesiologist thinks surgery is too risky for me.You must not have diabetes or must have a positive C-peptide test.You have used alcohol or tobacco in the past 6 months before the study.My pancreatic tumor is considered high risk for cancer by a specialized team.I have a cancer that started in a part of my body other than the pancreas and it has not been treated.I haven't taken any steroids like prednisone in the last month.The team of doctors does not think you are a good fit for the follow-up plan after the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (pancreatectomy, autologous islet cell transplant)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.