Skip to content

Quality of Life Assessment of Chronic Pancreatitis Endoscopic Interventions

Quality of Life Evaluation of Endoscopic Interventions in Chronic Pancreatitis

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03632616
Acronym
QOLAPI
Enrollment
500
Registered
2018-08-15
Start date
2017-07-01
Completion date
2026-08-01
Last updated
2024-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pancreatitis

Keywords

chronic pancreatitis, quality of life

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.

Interventions

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.

Sponsors

University of Colorado, Denver
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
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 useThe 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026