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Enrolling by Invitation

NCT Number: NCT03632616

Quality of Life Assessment of Chronic Pancreatitis Endoscopic Interventions

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Colorado Anschutz Medical Center, Aurora, Colorado, United States

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Visual Analog Scale for pain

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

Quality of Life Evaluation of Endoscopic Interventions in Chronic Pancreatitis

Acronym: QOLAPI

Important dates

Study start
2017
Primary completion
2025
Study completion
2026
First posted
Aug 15, 2018
Registry last updated
May 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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