Chronic PancreatitisEQuiPPNCT05012150
A Pilot Study in Endoscopic Therapy on Quality of Life and Pain in Chronic Pancreatitis
An observational study of Chronic Pancreatitis, run by Ohio State University at 1 site in United States.
Trial summary
This study is a prospective study designed to assess the effect of pancreatic endotherapy on quality of life, pain levels, pancreatic exocrine function, and endocrine function. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Chronic Pancreatitis
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2021to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with painful chronic pancreatitis who are being referred for pancreatic endotherapy will be eligible for participation in this study. Subjects who have already had prior endotherapy or surgery, however, will be excluded.
Who may be able to join
- Chronic Pancreatitis (as defined by the American Pancreatic Association Guidelines)
- Presence of Pain
- Referred for pancreatic endotherapy
Who cannot join
- Prior pancreatic endotherapy
- Prior pancreatic surgery
- Pregnant females
- Subjects unable to consent
- Imprisoned individuals
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
About this study
Official title: A Pilot Study in Endoscopic Therapy on Quality of Life and Pain in Chronic Pancreatitis: The EQuiPP Study
This study is a prospective study designed to assess the effect of pancreatic endotherapy on quality of life, pain levels, pancreatic exocrine function, and endocrine function.
Read the detailed description
Pancreatic endotherapy represents a potential treatment modality for patients with painful chronic pancreatitis. While pancreatic endotherapy is commonly performed, the effect of chronic pancreatitis on patient-centered outcomes remains poorly studied. Furthermore, the effect of endotherapy on pancreatic endocrine and exocrine are largely unknown. This study therefore aims to prospective observe patients with chronic pancreatitis after endotherapy is performed to better understand how it affects patient-centered outcomes such as pain and quality of life and pancreatic function. In doing so, the study also hopes to be able to predict which patients with chronic pancreatitis will benefit from pancreatic endotherapy.
- Conditions
- Chronic Pancreatitis
- Keywords
- ERCP, ESWL, quality of life, quantitative sensory testing, celiac plexus block, pancreatic duct stricture, pancreatic duct stenting, pancreatic fluid collection
- Medical subject headings
- Pancreatitis, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic Pancreatitis-Specific Quality of Life
Quality of life will be primarily assessed using the PANcreatitis Quality of Life Instrument (PANQOLI). Quality of life will be assessed before and after endotherapy (1, 3, 6, and 12 months). This instrument is based on a 0-87 scale with higher scores representing improved quality of life.
Measured: 12 months post-completion of endotherapy
Feasibility of Micro-Longitudinal Daily Pain Assessment
Pain will be assessed using daily pain diaries with the Brief Pain Inventory (BPI). These will be utilized to create short-term pain trajectories for subjects at baseline and post-procedure. This pain inventory includes 9 pain items graded on 0-10 scale with 10 being the worst pain.
Measured: 30-day post-procedure period
Secondary outcomes (11)
Overall Quality of Life
Quality of life will be primarily assessed using the PROMIS-29 instrument. Quality of life will be assessed before and after endotherapy (1, 3, 6, and 12 months). The PROMIS-29 instrument incorporates 7 domains: physical functioning, fatigue, pain interference, depression, anxiety, ability to participate in social roles and activities, and sleep disturbance. Each of these domains have a score 0-40 with higher scores representing worse quality of life in these domains. There are also 2 summary scores: Physical Health and Mental Health. Z-scores are calculated for these two summary scores with lower scores representing better quality of life.
Measured: 12 months post-completion of endotherapy
Change in Nociceptive Pain
Pain will be assessed using the PROMIS Nociceptive Pain Quality scales. Pain will be assessed before and after endotherapy (1, 3, 6, and 12 months). This pain scale goes from 5-25 with higher scores denoting worse pain.
Measured: 12 months post-completion of endotherapy
Change in Neuropathic Pain
Pain will be assessed using the PROMIS Neuropathic Pain. Pain will be assessed before and after endotherapy (1, 3, 6, and 12 months). This pain scale goes from 5-25 with higher scores denoting worse pain.
Measured: 12 months post-completion of endotherapy
Change in Pain Catastrophizing
Pain will be assessed using the UW Concerns about Pain Scale. Pain will be assessed before and after endotherapy (1, 3, 6, and 12 months). This pain scale ranges from 6 to 30 with higher scores denoting worse pain.
Measured: 12 months post-completion of endotherapy
Change in Self-Efficacy
Pain will be assessed using the Self-Efficacy Scale Short Form. Pain will be assessed before and after endotherapy (1, 3, 6, and 12 months). This pain scale ranges from 6 to 30 with higher scores denoting worse pain.
Measured: 12 months post-completion of endotherapy
Change in Chronic Pancreatitis-specific Pain
Pain will be assessed using the Comprehensive Pain Assessment Tool Short Form for Chronic Pancreatitis (COMPAT). Pain will be assessed before and after endotherapy (1, 3, 6, and 12 months). The COMPAT Short Form carries several sub-scores for pain pattern, pain severity, pain provocation, pain spreading, and pain description. The pain pattern scale ranges from 50-100 with higher scores denoting worse pain. The provocation score ranges from 0-70 with higher scores denoting worse pain. The severity score ranges from 0-100 with higher scores denoting worse pain. The spreading score ranges from 0-90 with higher scores denoting worse pain. The description score ranges from 0-80 with higher scores denoting worse pain. The total score ranges from 15-90 with higher scores denoting worse pain.
Measured: 12 months post-completion of endotherapy
Quantitative Sensory Testing
Pancreatic Quantitative Sensory Testing (QST) will be assessed once during the baseline enrollment in the study. The QST provides Z-scores. The Z-scores range from 0 to -1.96 with 0 representing a normal score and -1.96 representing more widespread sensitization.
Measured: The quantitative sensory testing will be assessed only once during the subject's baseline enrollment.
Pancreatic Endocrine Function via HbA1c
Pancreatic endocrine function will be assessed using the HbA1c. These will be measured before and after endotherapy (12 months). This is expressed as a % with higher values representing worse glycemic control.
Measured: 12 months post-completion of endotherapy
Insulin Resistance
Pancreatic endocrine function will be assessed using a HOMA-IR score to assess the degree of insulin resistance. These will be measured before and after endotherapy (12 months). This score assesses insulin resistance by calculating the ratio between the serum insulin level and the fasting glucose level. Higher scores denote worse insulin resistance.
Measured: 12 months post-completion of endotherapy
Insulin Sensitivity
Pancreatic endocrine function will be assessed using the QUICKI score, which measures the degree of insulin sensitivity. These will be measured before and after endotherapy (12 months). This is calculated using the ratio of fasting insulin and glucose. Lower levels denote worse insulin sensitivity.
Measured: 12 months post-completion of endotherapy
Pancreatic Exocrine Function
Pancreatic exocrine function will be assessed using endoscopic pancreatic function testing. This will be performed before endotherapy and at 12 months post-endotherapy.
Measured: 12 months post-completion of endotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2021
- Study start5 Jan 2021
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Dec 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 Ohio State UniversityThe 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
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- American Society for Gastrointestinal Endoscopy
- Responsible party
- Principal investigator, Mitchell Ramsey, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05012150
- Sponsor's protocol ID
- 2020H0410
- Acronym
- EQuiPP
- Status last verified
- Oct 2025
- First submitted
- 27 Jul 2021
- Last updated
- 24 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified study data will be made available to other researchers after completion of the study.
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study in Endoscopic Therapy on Quality of Life and Pain in Chronic Pancreatitis: The EQuiPP Study
- ClinicalTrials.gov ID
- NCT05012150
- Acronym / sponsor ID
- EQuiPP / 2020H0410
- Conditions
- Chronic Pancreatitis
- Keywords
- ERCP, ESWL, quality of life, quantitative sensory testing, celiac plexus block, pancreatic duct stricture, pancreatic duct stenting, pancreatic fluid collection
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- American Society for Gastrointestinal Endoscopy
- Study start
- 5 Jan 2021 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 19 Aug 2021 (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 is a prospective study designed to assess the effect of pancreatic endotherapy on quality of life, pain levels, pancreatic exocrine function, and endocrine function.
Detailed description
Pancreatic endotherapy represents a potential treatment modality for patients with painful chronic pancreatitis. While pancreatic endotherapy is commonly performed, the effect of chronic pancreatitis on patient-centered outcomes remains poorly studied. Furthermore, the effect of endotherapy on pancreatic endocrine and exocrine are largely unknown. This study therefore aims to prospective observe patients with chronic pancreatitis after endotherapy is performed to better understand how it affects patient-centered outcomes such as pain and quality of life and pancreatic function. In doing so, the study also hopes to be able to predict which patients with chronic pancreatitis will benefit from pancreatic endotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with painful chronic pancreatitis who are being referred for pancreatic endotherapy will be eligible for participation in this study. Subjects who have already had prior endotherapy or surgery, however, will be excluded.
Key inclusion criteria (3 listed)
- Chronic Pancreatitis (as defined by the American Pancreatic Association Guidelines)
- Presence of Pain
- Referred for pancreatic endotherapy
Key exclusion criteria (5 listed)
- Prior pancreatic endotherapy
- Prior pancreatic surgery
- Pregnant females
- Subjects unable to consent
- Imprisoned individuals
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Chronic Pancreatitis-Specific Quality of Life
Time frame: 12 months post-completion of endotherapy
Quality of life will be primarily assessed using the PANcreatitis Quality of Life Instrument (PANQOLI). Quality of life will be assessed before and after endotherapy (1, 3, 6, and 12 months). This instrument is based on a 0-87 scale with higher scores representing improved quality of life.
Feasibility of Micro-Longitudinal Daily Pain Assessment
Time frame: 30-day post-procedure period
Pain will be assessed using daily pain diaries with the Brief Pain Inventory (BPI). These will be utilized to create short-term pain trajectories for subjects at baseline and post-procedure. This pain inventory includes 9 pain items graded on 0-10 scale with 10 being the worst pain.
11 secondary outcomes
Overall Quality of Life
Time frame: 12 months post-completion of endotherapy
Change in Nociceptive Pain
Time frame: 12 months post-completion of endotherapy
Change in Neuropathic Pain
Time frame: 12 months post-completion of endotherapy
Change in Pain Catastrophizing
Time frame: 12 months post-completion of endotherapy
Change in Self-Efficacy
Time frame: 12 months post-completion of endotherapy
Change in Chronic Pancreatitis-specific Pain
Time frame: 12 months post-completion of endotherapy
Quantitative Sensory Testing
Time frame: The quantitative sensory testing will be assessed only once during the subject's baseline enrollment.
Pancreatic Endocrine Function via HbA1c
Time frame: 12 months post-completion of endotherapy
Insulin Resistance
Time frame: 12 months post-completion of endotherapy
Insulin Sensitivity
Time frame: 12 months post-completion of endotherapy
Pancreatic Exocrine Function
Time frame: 12 months post-completion of endotherapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2025.
- Individual participant dataSharing planned: Yes. Deidentified study data will be made available to other researchers after completion of the study.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 Ohio State University at 1 site 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 3 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 24 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
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?
Chronic Pancreatitis-Specific Quality of Life (time frame: 12 months post-completion of endotherapy). The study lists 2 primary outcomes in all. 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 24 Oct 2025.