Quality of Life Assessment of Chronic Pancreatitis Endoscopic Interventions

NCT03632616 | Enrolling By Invitation

• 1 other identifier: 16-1816
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Pancreatitis

Keywords

chronic pancreatitis; quality of life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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.

• Change in pain medication use

  The outcome will be measured at 1, 3, and 6 months post-intervention.

Interventions

PANQOLI (quality of life instrument) OTHER

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

Also known as: Visual Analog Scale for pain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of patients with painful chronic pancreatitis who are being referred for endoscopic treatment to reduce their pain.

You may qualify if:

• 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.

You may not qualify if:

• Pregnant females
• Prisoners
• Patients under the age of 18
• Patients lacking the capacity to consent

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (2)

University of Colorado Anschutz Medical Center

Aurora, Colorado, 80045, United States

Location

Johns Hopkins

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Pancreatitis, Chronic

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Raj J Shah, MD

  Professor of Medicine; Director, Pancreas and Biliary Endoscopy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2018
• First Posted: August 15, 2018
• Study Start: July 1, 2017
• Primary Completion: August 1, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: May 22, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)