An observational study in Chronic Pancreatitis, sponsored by Ohio State University. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-10-24.
Sponsored by Ohio State University · Observational
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.
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.
264 studies on the registry are indexed under Pancreatitis, Chronic; 73 are open to participants now.
This study's planned enrollment of 32 is below the median of 300 across 114 observational studies indexed under Pancreatitis, Chronic.
Browse Pancreatitis, Chronic studies →Ohio State University is the lead sponsor of 640 studies on the registry; 144 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 45 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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.
Time frame: 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.
Time frame: 30-day post-procedure period
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months post-completion of endotherapy
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Deidentified study data will be made available to other researchers after completion of the study.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
This study is active, not recruiting, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
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Ohio State University