Quality of Life Assessment of Chronic Pancreatitis Endoscopic Interventions (QOLAPI)
May 20, 2024 updated by: University of Colorado, Denver
Quality of Life Evaluation of Endoscopic Interventions in Chronic Pancreatitis
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.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Estimated)
500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- University of Colorado Anschutz Medical Center
-
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Maryland
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Baltimore, Maryland, United States, 21287
- Johns Hopkins
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
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.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Quality of Life using the PANQOLI (PANcreatitis Quality of Life Instrument)
Time Frame: 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.
|
The outcome will be measured at 1, 3, and 6 months post-intervention.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in pain level using the Visual Analog Scale (VAS) for pain.
Time Frame: 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
|
The outcome will be measured at 1, 3, and 6 months post-intervention.
|
|
Change in pain medication use
Time Frame: 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.
|
The outcome will be measured at 1, 3, and 6 months post-intervention.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Raj J Shah, MD, Professor of Medicine; Director, Pancreas and Biliary Endoscopy
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2017
Primary Completion (Estimated)
August 1, 2025
Study Completion (Estimated)
August 1, 2026
Study Registration Dates
First Submitted
August 10, 2018
First Submitted That Met QC Criteria
August 13, 2018
First Posted (Actual)
August 15, 2018
Study Record Updates
Last Update Posted (Actual)
May 22, 2024
Last Update Submitted That Met QC Criteria
May 20, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-1816
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.