Chronic PancreatitisQOLAPINCT03632616
Quality of Life Assessment of Chronic Pancreatitis Endoscopic Interventions
An observational study of Chronic Pancreatitis, run by University of Colorado, Denver at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pancreatitis
- What is being tested?
- PANQOLI (quality of life instrument)
- How many people
- 500 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jul 2017to 1 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: The study population will consist of patients with painful chronic pancreatitis who are being referred for endoscopic treatment to reduce their pain.
Who may be able to join
- 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.
Who cannot join
- Pregnant females
- Prisoners
- Patients under the age of 18
- Patients lacking the capacity to consent
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Colorado Anschutz Medical Center
Aurora, Colorado, 80045
Johns Hopkins
Baltimore, Maryland, 21287
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Pancreatitis
- Being tested
- PANQOLI (quality of life instrument)
- Keywords
- chronic pancreatitis, quality of life
- Medical subject headings
- Pancreatitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PANQOLI (quality of life instrument)Other
Also called Visual Analog Scale for pain
A quality of life instrument, the PANQOLI, will be administered prior to endoscopic intervention, and at 1,3, 6 and 12 months post-intervention.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 secondary outcome will include the change in pain using the Visual Analog Scale (VAS) for pain after endoscopic intervention
Measured: The outcome will be measured at 1, 3, and 6 months post-intervention.
Change in pain medication use
The secondary outcome will include the change in pain medication use after endoscopic intervention.
Measured: The outcome will be measured at 1, 3, and 6 months post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start1 Jul 2017
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PancreatitisStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raj J Shah, MD, Principal investigator, Professor of Medicine; Director, Pancreas and Biliary Endoscopy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03632616
- Sponsor's protocol ID
- 16-1816
- Acronym
- QOLAPI
- Status last verified
- May 2024
- First submitted
- 10 Aug 2018
- Last updated
- 22 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life Evaluation of Endoscopic Interventions in Chronic Pancreatitis
- ClinicalTrials.gov ID
- NCT03632616
- Acronym / sponsor ID
- QOLAPI / 16-1816
- Conditions
- Chronic Pancreatitis
- Keywords
- chronic pancreatitis, quality of life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 15 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of patients with painful chronic pancreatitis who are being referred for endoscopic treatment to reduce their pain.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- Pregnant females
- Prisoners
- Patients under the age of 18
- Patients lacking the capacity to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PANQOLI (quality of life instrument)Also: Visual Analog Scale for painA quality of life instrument, the PANQOLI, will be administered prior to endoscopic intervention, and at 1,3, 6 and 12 months post-intervention. | Other | – |
Primary outcome
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.
2 secondary outcomes
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.
Change in pain medication use
Time frame: The outcome will be measured at 1, 3, and 6 months post-intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raj J Shah, MD principal investigator
Professor of Medicine; Director, Pancreas and Biliary Endoscopy
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pancreatitis, run by University of Colorado, Denver at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2024.