Quality of Life Assessment of Chronic Pancreatitis Endoscopic Interventions (QOLAPI)

April 14, 2023 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

Recruiting

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 (Anticipated)

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 Contact

Study Contact Backup

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado Anschutz Medical Center
        • Principal Investigator:
          • Raj J Shah, MD
        • Sub-Investigator:
          • Samuel Y Han, MD
        • Contact:
        • Contact:
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Not yet recruiting
        • Johns Hopkins
        • Principal Investigator:
          • Vikesh Singh, MD, MSc
        • Contact:

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

University of Colorado, Denver

Collaborators

Johns Hopkins University

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 (Anticipated)

August 1, 2025

Study Completion (Anticipated)

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)

April 19, 2023

Last Update Submitted That Met QC Criteria

April 14, 2023

Last Verified

April 1, 2023

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.

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