Trial of Pancreatic Enzyme Supplements (Pancrelipase) for Treating Pain in Patients With Chronic Pancreatitis

• Status: Withdrawn
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The study purpose is to characterize the effect of pancreatic enzyme supplementation on chronic pancreatitis type pain.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dartmouth-Hitchcock Medical Center
• Treatments: Pancreatin; Pancrelipase

Criteria

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