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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of patients that are free of metastatic disease to the liver from a pancreatic primary
Secondary outcome measures
Insulin free rate
Opiates free rate
Time to overall survival (OS)
Other outcome measures
Incidence of adverse events (AEs)
Pain
Quality of life (QOL)
Side effects data
From 2022 Phase 2 trial • 147 Patients • NCT0256271677%
Fatigue
74%
Diarrhea
72%
Nausea
60%
Anemia
53%
Peripheral sensory neuropathy
47%
Hypoalbuminemia
47%
Alkaline phosphatase increased
47%
Neutrophil count decreased
45%
Anorexia
45%
Abdominal pain
43%
Alanine aminotransferase increased
40%
Hypokalemia
40%
Weight loss
40%
Aspartate aminotransferase increased
38%
Platelet count decreased
34%
Hyperglycemia
32%
Vomiting
28%
Constipation
28%
White blood cell decreased
21%
Hyponatremia
21%
Dysgeusia
21%
Hypocalcemia
19%
Fever
19%
Hypomagnesemia
19%
Dizziness
17%
Dehydration
15%
Hypotension
15%
Hypertension
15%
Chills
13%
Generalized muscle weakness
13%
Mucositis oral
13%
Headache
13%
Anxiety
13%
Pain
11%
Paresthesia
11%
Thromboembolic event
11%
Lymphocyte count decreased
11%
Dyspepsia
11%
Blood bilirubin increased
11%
Back pain
11%
Depression
9%
Infusion related reaction
9%
Cough
9%
Nervous system disorders-Other
9%
Skin infection
9%
Insomnia
9%
Dyspnea
9%
Rash maculo-papular
9%
Alopecia
8%
Gastrointestinal disorders-Other
8%
Allergic reaction
8%
Blurred vision
8%
Peripheral motor neuropathy
8%
Flatulence
8%
Creatinine increased
8%
Investigations-Other
8%
Arthralgia
6%
Malaise
6%
Non-cardiac chest pain
6%
Infections and infestations-Other
6%
Edema limbs
6%
Sinus tachycardia
6%
Bloating
6%
Hemorrhoids
6%
Postnasal drip
6%
Dysphagia
6%
Weight gain
6%
Eye disorders-Other
6%
Bone pain
6%
Neck pain
6%
Skin and subcutaneous tissue disorders - Other
6%
Upper respiratory infection
6%
Wound infection
6%
Fall
4%
Abdominal distension
4%
Neck edema
4%
Gastroparesis
4%
Myocardial infarction
4%
Dry eye
4%
Gastroesophageal reflux disease
4%
Dysesthesia
4%
Pain of skin
4%
Dry skin
4%
Myalgia
4%
Hoarseness
4%
Tinnitus
4%
Vertigo
4%
Flu like symptoms
4%
Pain in extremity
4%
Skin ulceration
4%
Watering eyes
4%
Confusion
4%
Dry mouth
4%
Urinary tract infection
2%
Fracture
2%
Mucosal infection
2%
Pancreatitis
2%
Oral pain
2%
Anal pain
2%
Irritability
2%
Pancreatic enzymes decreased
2%
Lung infection
2%
Pruritus
2%
Localized edema
2%
Malabsorption
2%
Hypernatremia
2%
Cardiac arrest
2%
Dysphasia
2%
Hearing impaired
2%
Hypermagnesemia
2%
Abdominal infection
2%
Sepsis
2%
Colitis
2%
Colonic perforation
2%
Memory impairment
2%
Injury, poison and procedural complications - Other
2%
Hyperkalemia
2%
General disorders and admin site conditions - Other
2%
Pancreatic anastomotic leak
2%
Flank pain
2%
Purpura
2%
Gait disturbance
2%
Hypothermia
2%
Hypoglycemia
2%
Metabolism and nutrition disorders - Other, specify
2%
Hypertriglyceridemia
2%
Hypophosphatemia
2%
Flushing
2%
Movements involuntary
2%
Wheezing
2%
Pleuritic pain
2%
Tremor
2%
Sore throat
2%
Hyperhidrosis
2%
Hot flashes
2%
Esophagitis
2%
Bile duct stenosis
2%
Ataxia
2%
Hepatobiliary disorders-Other
2%
Sinus bradycardia
2%
Leukocytosis
2%
Eye pain
2%
Dental caries
2%
Toothache
2%
Upper gastrointestinal hemorrhage
2%
Cholesterol high
2%
Muscle weakness lower limb
2%
Dysarthria
2%
Renal and urinary disorders-Other
2%
Renal calculi
2%
Renal colic
2%
Urinary incontinence
2%
Urinary retention
2%
Nasal congestion
2%
Bruising
2%
Wound complication
2%
Activated partial thromboplastin time prolonged
100%
80%
60%
40%
20%
0%
Study treatment Arm
mFOLFIRINOX->Surg->mFOLFIRINOX
Gem/Nab-P->Surg->Gem/Nab-P
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
230 Previous Clinical Trials
2,090,714 Total Patients Enrolled
Oregon Health and Science UniversityOTHER
973 Previous Clinical Trials
6,846,017 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is it possible to sign up for this test right now?
"Unfortunately, this trial is no longer recruiting patients. The clinicaltrials.gov website reports that the posting date was November 1st, 2022 and the last update was July 7th, 2022. Although this particular study isn't looking for more participants, there are 3 thousand and 79 other trials currently enrolling candidates."
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