Quality of Life Assessment of Chronic Pancreatitis Endoscopic Interventions



Status:Recruiting
Conditions:Gastrointestinal, Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:8/17/2018
Start Date:July 1, 2017
End Date:July 1, 2021
Contact:Samuel Y Han, MD
Email:samuel.han@ucdenver.edu
Phone:617-640-1495

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Quality of Life Evaluation of Endoscopic Interventions in Chronic Pancreatitis

This study seeks to evaluate the effect of endoscopic interventions on quality of life in
patients with chronic pancreatitis. Quality of life will be evaluated using the PANQOLI, a
validated quality of life instrument specific to chronic pancreatitis. Endoscopic
interventions will include pancreatic duct dilation and stenting, celiac plexus block,
lithotripsy and removal of pancreatic duct stones, and pseudocyst drainage.

This is a multicenter prospective cohort study assessing the impact of endoscopic
interventions on patients with chronic pancreatitis. Patients with chronic pancreatitis
referred for endoscopic treatment, including pancreatic duct dilation and stenting,
pseudocyst drainage, celiac plexus blocks, and pseudocyst drainage/necrosectomy will be
enrolled in this study. They will receive a baseline evaluation using the PANQOLI, a chronic
pancreatitis-specific quality of life instrument, in addition to a visual analog scale to
measure their pain. Demographic and endoscopic features will be collected in addition to pain
medication use. Patients will receive follow-up at 1, 3, and 6 months post-intervention
consisting of the PANQOLI, visual analog scale for pain, and pain medication use.

Inclusion Criteria:

- Patients with painful chronic pancreatitis, defined as either 1) the presence of
pancreatic calcifications on cross-sectional imaging, 2) morphologic changes
consistent with the Rosemont criteria on endoscopic ultrasound, or 3) endoscopic
pancreatic function test results consistent with decreased pancreatic function.

Exclusion Criteria:

- Pregnant females

- Prisoners

- Patients under the age of 18

- Patients lacking the capacity to consent
We found this trial at
2
sites
Baltimore, Maryland 21218
(410) 516-8000
Principal Investigator: Vikesh Singh, MD, MSc
Johns Hopkins The Johns Hopkins University opened in 1876, with the inauguration of its first...
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Aurora, Colorado 80045
Principal Investigator: Raj J Shah, MD
Phone: 617-640-1495
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