Clinical trial NCT03632616: Quality of Life Assessment of Chronic Pancreatitis Endoscopic Interventions
Official title: Quality of Life Evaluation of Endoscopic Interventions in Chronic Pancreatitis
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Chronic Pancreatitis
Keywords: chronic pancreatitis
quality of life
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2018-08-15
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of patients with painful chronic pancreatitis who are being referred for endoscopic treatment to reduce their pain.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Quality of Life using the PANQOLI (PANcreatitis Quality of Life Instrument)
timeFrame: The outcome will be measured at 1, 3, and 6 months post-intervention.
Secondary outcomes:
measure: Change in pain level using the Visual Analog Scale (VAS) for pain.
timeFrame: The outcome will be measured at 1, 3, and 6 months post-intervention.
measure: Change in pain medication use
timeFrame: The outcome will be measured at 1, 3, and 6 months post-intervention.
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Center
state: Colorado
city: Baltimore
country: United States
facility: Johns Hopkins
state: Maryland
Study officials:
affiliation: Professor of Medicine; Director, Pancreas and Biliary Endoscopy
name: Raj J Shah, MD
role: PRINCIPAL_INVESTIGATOR
References: