Quality of Life Assessment of Chronic Pancreatitis Endoscopic Interventions (QOLAPI)

University of Colorado Denver (CU Denver) logo

University of Colorado Denver (CU Denver)

Status

Invitation-only

Conditions

Chronic Pancreatitis

Treatments

Other: PANQOLI (quality of life instrument)

Study type

Observational

Funder types

Other

Identifiers

NCT03632616
16-1816

Details and patient eligibility

About

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.

Full 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.

Enrollment

500 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

2

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Central trial contact

Eze Ezekwe, BA; Samuel Y Han, MD

Data sourced from clinicaltrials.gov

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