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Trial record 1 of 456 for:    "hereditary pancreatitis" OR "Pancreatitis, Chronic" OR "Pancreatitis"
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Quality of Life Assessment of Chronic Pancreatitis Endoscopic Interventions (QOLAPI)

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ClinicalTrials.gov Identifier: NCT03632616
Recruitment Status : Recruiting
First Posted : August 15, 2018
Last Update Posted : October 3, 2019
Sponsor:
Collaborator:
Johns Hopkins University
Information provided by (Responsible Party):
University of Colorado, Denver

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.

Condition or disease Intervention/treatment
Chronic Pancreatitis Other: PANQOLI (quality of life instrument)

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.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Quality of Life Evaluation of Endoscopic Interventions in Chronic Pancreatitis
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: PANQOLI (quality of life instrument)
    A quality of life instrument, the PANQOLI, will be administered prior to endoscopic intervention, and at 1,3, and 6 months post-intervention.
    Other Name: Visual Analog Scale for pain


Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03632616


Contacts
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Contact: Samuel Y Han, MD 617-640-1495 samuel.han@ucdenver.edu
Contact: Eze Ezekwe, BA Eze.Ezekwe@ucdenver.edu

Locations
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United States, Colorado
University of Colorado Anschutz Medical Center Recruiting
Aurora, Colorado, United States, 80045
Contact: Samuel Han, MD    617-640-1495    samuel.han@ucdenver.edu   
Principal Investigator: Raj J Shah, MD         
Sub-Investigator: Samuel Y Han, MD         
United States, Maryland
Johns Hopkins Not yet recruiting
Baltimore, Maryland, United States, 21287
Contact: Mahya Faghih, MD       mfaghih2@jhu.edu   
Principal Investigator: Vikesh Singh, MD, MSc         
Sponsors and Collaborators
University of Colorado, Denver
Johns Hopkins University

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03632616     History of Changes
Other Study ID Numbers: 16-1816
First Posted: August 15, 2018    Key Record Dates
Last Update Posted: October 3, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Colorado, Denver:
chronic pancreatitis
quality of life
Additional relevant MeSH terms:
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Pancreatitis
Pancreatitis, Chronic
Pancreatic Diseases
Digestive System Diseases