nctId: NCT06267365 id: 23-00766 briefTitle: Predictive Biomarker for Endoscopic Therapy in Chronic Pancreatitis overallStatus: RECRUITING date: 2023-11-27 date: 2025-06-01 date: 2025-09-01 date: 2024-02-20 date: 2024-02-20 name: NYU Langone Health class: OTHER name: National Institute of Neurological Disorders and Stroke (NINDS) briefSummary: This is an observational prospective study to develop predictive biomarkers for pain response in participants with chronic pancreatitis scheduled for endoscopic therapy. Participants will undergo baseline assessments including electroencephalography (EEG), quantitative sensory testing (QST), and psychosocial questionnaires. Response to endoscopic therapy will be assessed at approximately 3, 6, 12 and 18 months post-procedure using questionnaires. conditions: Chronic Pancreatitis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED measure: Change from Baseline in Brief Pain Inventory (BPI) Score at Month 3 Post-Operation measure: Change from Baseline in BPI Score at Month 6 Post-Operation measure: Change from Baseline in BPI Score at Month 12 Post-Operation measure: Change from Baseline in BPI Score at Month 18 Post-Operation measure: Change from Baseline in Patient Reported Outcome System (PROMIS) - Physical Function - Short Form 6b Score at Month 3 Post-Operation measure: Change from Baseline in PROMIS - Physical Function - Short Form 6b Score at Month 6 Post-Operation measure: Change from Baseline in PROMIS - Physical Function - Short Form 6b Score at Month 12 Post-Operation measure: Change from Baseline in PROMIS - Physical Function - Short Form 6b Score at Month 18 Post-Operation measure: Number of Participants who use Opioids at Baseline measure: Number of Participants who use Opioids at Month 3 measure: Number of Participants who use Opioids at Month 6 measure: Number of Participants who use Opioids at Month 12 measure: Number of Participants who use Opioids at Month 18 measure: Change from Baseline in PROMIS - Depression - Short Form 4a Score at Month 3 Post-Procedure measure: Change from Baseline in PROMIS - Depression - Short Form 4a Score at Month 6 Post-Procedure measure: Change from Baseline in PROMIS - Depression - Short Form 4a Score at Month 12 Post-Procedure measure: Change from Baseline in PROMIS - Depression - Short Form 4a Score at Month 18 Post-Procedure measure: Change from Baseline in PROMIS - Anxiety- Short Form 4a Score at Month 3 Post-Procedure measure: Change from Baseline in PROMIS - Anxiety- Short Form 4a Score at Month 6 Post-Procedure measure: Change from Baseline in PROMIS - Anxiety- Short Form 4a Score at Month 12 Post-Procedure measure: Change from Baseline in PROMIS - Anxiety- Short Form 4a Score at Month 18 Post-Procedure measure: Change from Baseline in PROMIS - Neuropathic Pain Quality 5a Score at Month 3 Post-Procedure measure: Change from Baseline in PROMIS - Neuropathic Pain Quality 5a Score at Month 6 Post-Procedure measure: Change from Baseline in PROMIS - Neuropathic Pain Quality 5a Score at Month 12 Post-Procedure measure: Change from Baseline in PROMIS - Neuropathic Pain Quality 5a Score at Month 18 Post-Procedure measure: Change from Baseline in PROMIS - Sleep Disturbance - Short Form 6a Score at Month 3 Post-Procedure measure: Change from Baseline in PROMIS - Sleep Disturbance - Short Form 6a Score at Month 6 Post-Procedure measure: Change from Baseline in PROMIS - Sleep Disturbance - Short Form 6a Score at Month 12 Post-Procedure measure: Change from Baseline in PROMIS - Sleep Disturbance - Short Form 6a Score at Month 18 Post-Procedure measure: Change from Baseline in PROMIS - Fatigue - Short Form 6a Score at Month 3 Post-Procedure measure: Change from Baseline in PROMIS - Fatigue - Short Form 6a Score at Month 6 Post-Procedure measure: Change from Baseline in PROMIS - Fatigue - Short Form 6a Score at Month 12 Post-Procedure measure: Change from Baseline in PROMIS - Fatigue - Short Form 6a Score at Month 18 Post-Procedure measure: Change from Baseline in Pain Catastrophizing Scale (PCS) Score at Month 3 Post-Procedure measure: Change from Baseline in PCS Score at Month 6 Post-Procedure measure: Change from Baseline in PCS Score at Month 12 Post-Procedure measure: Change from Baseline in PCS Score at Month 18 Post-Procedure measure: Change from Baseline in Sleep Duration at Month 3 Post-Procedure measure: Change from Baseline in Sleep Duration at Month 6 Post-Procedure measure: Change from Baseline in Sleep Duration at Month 12 Post-Procedure measure: Change from Baseline in Sleep Duration at Month 18 Post-Procedure measure: Change from Baseline in Tobacco, Alcohol, Prescription medications, and other Substance (TAPS) Score at Month 3 Post-Procedure measure: Change from Baseline in TAPS Score at Month 6 Post-Procedure measure: Change from Baseline in TAPS Score at Month 12 Post-Procedure measure: Change from Baseline in TAPS Score at Month 18 Post-Procedure measure: Change from Baseline in Patient Global Impression of Change (PGIC) Score at Month 3 Post-Procedure measure: Change from Baseline in PGIC Score at Month 6 Post-Procedure measure: Change from Baseline in PGIC Score at Month 12 Post-Procedure measure: Change from Baseline in PGIC Score at Month 18 Post-Procedure measure: Change from Baseline in Patient Health Questionnaire-2 (PHQ-2) Score at Month 3 Post-Procedure measure: Change from Baseline in PHQ-2 Score at Month 6 Post-Procedure measure: Change from Baseline in PHQ-2 Score at Month 12 Post-Procedure measure: Change from Baseline in PHQ-2 Score at Month 18 Post-Procedure measure: Change from Baseline in Generalized Anxiety Disorder 2 (GAD-2) Score at Month 3 Post-Procedure measure: Change from Baseline in GAD-2 Score at Month 6 Post-Procedure measure: Change from Baseline in GAD-2 Score at Month 12 Post-Procedure measure: Change from Baseline in GAD-2 Score at Month 18 Post-Procedure measure: Change from Baseline in Pain, Enjoyment of Life and General Activity (PEG) Scale at Month 3 Post-Procedure measure: Change from Baseline in PEG Scale at Month 6 Post-Procedure measure: Change from Baseline in PEG Scale at Month 12 Post-Procedure measure: Change from Baseline in PEG Scale at Month 18 Post-Procedure sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: NYU Langone Health status: RECRUITING city: New York state: New York zip: 10016 country: United States lat: 40.71427 lon: -74.00597 hasResults: False