Pancreatitis
Conditions
Brief summary
The study purpose is to characterize the effect of pancreatic enzyme supplementation on chronic pancreatitis type pain.
Detailed description
Study Type: Interventional, randomized, double-blind, placebo-controlled, crossover design, efficacy study Intervention arm: Pancreatic enzyme replacement (Pancrelipase) with meals and snacks daily, for 4 weeks. Placebo arm: Lactose placebo tablets with meals and snacks, for 4 weeks. Washout Phase: Weeks 4 to 6, there will be cessation of placebo or Pancrelipase use. Crossover Phase: Weeks 6 to 10, initial placebo arm receives Pancrelipase, Pancrelipase arm receives placebo Surveys - Izbicki score and PANQOLI assessment occur at Week 0, 4, 6, and 10. Narcotic and non-narcotic usage will also be noted at these intervals. Patient will also report the tobacco and alcohol use.
Interventions
DRUGPancrelipase
Oral Pancrelipase, 720,000 units spread throughout the day with meals and snacks, taken daily PO for 4 weeks
DRUGplacebo
Placebo will consist of lactose, spread throughout the day with meals and snacks, taken daily PO for 4 weeks
Sponsors
Dartmouth-Hitchcock Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of chronic pancreatitis based on chronic pancreatitis-type pain \> 6 months leading to impaired quality of life AND at least 1 of the following (27): * Confirmed diagnosis of hereditary pancreatitis (PRSS1 gene mutation) * History of recurrent acute pancreatitis (\>1 documented episode of characteristic abdominal pain associated with diagnostic imaging and/or elevated serum amylase or lipase \> 3 times upper limit of normal). * Pancreatic calcifications on CT scan * At least 2 of the following: * Endoscopic Ultrasound (EUS) with = or \> 4 criteria for chronic pancreatitis (hyperechoic foci, strands, or ducts, lobulation, irregular duct margin, visible side - branches, calcifications, cysts, ductal dilatation) (28) * Ductal (changes in side branch morphology) or parenchymal (loss of T1 signal intensity) abnormalities on secretin enhanced Magnetic resonance cholangiopancreatography (MRCP) * Abnormal endoscopic pancreatic secretory function tests (HCO3 \<= 75mmol/L at 30 or 45 minutes or \<= 80mmol/L at 1 hour * Subjects are capable of informed consent
Exclusion criteria
* Pregnancy * Lactation * Active acute pancreatitis or an episode of acute pancreatitis within 2 months of presentation for evaluation * Pancreatic cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain scores based on Izbicki self-assessment score | Measured at weeks 0,4,6 and 10 | Difference in pain scores based on Izbicki self-assessment will be evaluated to determine if pancrelipase improves pain symptoms in patients with chronic pancreatitis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life | Pancreatic Quality of Life Instrument (PANQOLI) assessment at weeks 0, 4, 6 and 10 | Difference in quality of live evaluated on PANQOLI assessment |
| Change in Narcotic Use | 0, 4, 6 and 10 weeks of treatment | Difference in narcotic and non-narcotic use at 0, 4, 6 and 10 weeks of treatment as measured by morphine equivalents |
Countries
United States
Outcome results
None listed