Quality of Life Assessment of Chronic Pancreatitis Endoscopic Interventions

Chronic Pancreatitis Clinical Trial

— QOLAPI  

Official title:

Quality of Life Evaluation of Endoscopic Interventions in Chronic Pancreatitis

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03632616
• Other study ID #: 16-1816
• Status: Enrolling by invitation
• Start date: July 1, 2017
• Est. completion date: August 1, 2026

Study information

• Verified date: May 2024
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 500
• Est. completion date: August 1, 2026
• Est. primary completion date: August 1, 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pancreatitis
• Pancreatitis
• Pancreatitis, Chronic

Intervention

Other:
• PANQOLI (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.

Locations

Country	Name	City	State
United States	University of Colorado Anschutz Medical Center	Aurora	Colorado
United States	Johns Hopkins	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Quality of Life using the PANQOLI (PANcreatitis Quality of Life Instrument)	The primary outcome will be the change in quality of life using the PANQOLI (PANcreatitis Quality of Life Instrument) after endoscopic intervention.	The outcome will be measured at 1, 3, and 6 months post-intervention.
Secondary	Change in pain level using the Visual Analog Scale (VAS) for pain.	The secondary outcome will include the change in pain using the Visual Analog Scale (VAS) for pain after endoscopic intervention	The outcome will be measured at 1, 3, and 6 months post-intervention.
Secondary	Change in pain medication use	The secondary outcome will include the change in pain medication use after endoscopic intervention.	The outcome will be measured at 1, 3, and 6 months post-intervention.