Quality of Life Assessment of Chronic Pancreatitis Endoscopic Interventions

• Conditions: Chronic Pancreatitis

• Registration Number: NCT03632616
• Lead Sponsor: University of Colorado, Denver

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.

Study Timeline

• Study Start: 2017-07-01
• Study First Submitted: 2018-08-10
• Study First Submitted QC: 2018-08-13
• Study First Posted: 2018-08-15
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-20
• Last Update Posted: 2024-05-22
• Primary Completion: 2025-08-01
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Quality of Life using the PANQOLI (PANcreatitis Quality of Life Instrument)	The outcome will be measured at 1, 3, and 6 months post-intervention.	The primary outcome will be the change in quality of life using the PANQOLI (PANcreatitis Quality of Life Instrument) after endoscopic intervention.

Secondary Outcome Measures

Name	Time	Method
Change in pain level using the Visual Analog Scale (VAS) for pain.	The outcome will be measured at 1, 3, and 6 months post-intervention.	The secondary outcome will include the change in pain using the Visual Analog Scale (VAS) for pain after endoscopic intervention
Change in pain medication use	The outcome will be measured at 1, 3, and 6 months post-intervention.	The secondary outcome will include the change in pain medication use after endoscopic intervention.

Trial Locations

Locations (2)

University of Colorado Anschutz Medical Center; 🇺🇸 Aurora, Colorado, United States

Johns Hopkins; 🇺🇸 Baltimore, Maryland, United States