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Enrolling By InvitationNCT03632616

Quality of Life Assessment of Chronic Pancreatitis Endoscopic Interventions

Quality of Life Evaluation of Endoscopic Interventions in Chronic Pancreatitis

Status
Enrolling By Invitation
Phase
Study type
Observational
Enrollment
500 (estimated)
Sponsor
University of Colorado, Denver · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers

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.

Conditions

Interventions

TypeNameDescription
OTHERPANQOLI (quality of life instrument)A quality of life instrument, the PANQOLI, will be administered prior to endoscopic intervention, and at 1,3, 6 and 12 months post-intervention.

Timeline

Start date
2017-07-01
Primary completion
2025-08-01
Completion
2026-08-01
First posted
2018-08-15
Last updated
2024-05-22

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT03632616. Inclusion in this directory is not an endorsement.