protocolSection identificationModule nctId: NCT06267365, orgStudyIdInfo id: 23-00766, briefTitle: Predictive Biomarker for Endoscopic Therapy in Chronic Pancreatitis, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-27, primaryCompletionDateStruct date: 2025-06-01, completionDateStruct date: 2025-09-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: NYU Langone Health, class: OTHER, collaborators name: National Institute of Neurological Disorders and Stroke (NINDS), descriptionModule 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., conditionsModule conditions: Chronic Pancreatitis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Change from Baseline in Brief Pain Inventory (BPI) Score at Month 3 Post-Operation, secondaryOutcomes measure: Change from Baseline in BPI Score at Month 6 Post-Operation, secondaryOutcomes measure: Change from Baseline in BPI Score at Month 12 Post-Operation, secondaryOutcomes measure: Change from Baseline in BPI Score at Month 18 Post-Operation, secondaryOutcomes measure: Change from Baseline in Patient Reported Outcome System (PROMIS) - Physical Function - Short Form 6b Score at Month 3 Post-Operation, secondaryOutcomes measure: Change from Baseline in PROMIS - Physical Function - Short Form 6b Score at Month 6 Post-Operation, secondaryOutcomes measure: Change from Baseline in PROMIS - Physical Function - Short Form 6b Score at Month 12 Post-Operation, secondaryOutcomes measure: Change from Baseline in PROMIS - Physical Function - Short Form 6b Score at Month 18 Post-Operation, secondaryOutcomes measure: Number of Participants who use Opioids at Baseline, secondaryOutcomes measure: Number of Participants who use Opioids at Month 3, secondaryOutcomes measure: Number of Participants who use Opioids at Month 6, secondaryOutcomes measure: Number of Participants who use Opioids at Month 12, secondaryOutcomes measure: Number of Participants who use Opioids at Month 18, secondaryOutcomes measure: Change from Baseline in PROMIS - Depression - Short Form 4a Score at Month 3 Post-Procedure, secondaryOutcomes measure: Change from Baseline in PROMIS - Depression - Short Form 4a Score at Month 6 Post-Procedure, secondaryOutcomes measure: Change from Baseline in PROMIS - Depression - Short Form 4a Score at Month 12 Post-Procedure, secondaryOutcomes measure: Change from Baseline in PROMIS - Depression - Short Form 4a Score at Month 18 Post-Procedure, secondaryOutcomes measure: Change from Baseline in PROMIS - Anxiety- Short Form 4a Score at Month 3 Post-Procedure, secondaryOutcomes measure: Change from Baseline in PROMIS - Anxiety- Short Form 4a Score at Month 6 Post-Procedure, secondaryOutcomes measure: Change from Baseline in PROMIS - Anxiety- Short Form 4a Score at Month 12 Post-Procedure, secondaryOutcomes measure: Change from Baseline in PROMIS - Anxiety- Short Form 4a Score at Month 18 Post-Procedure, secondaryOutcomes measure: Change from Baseline in PROMIS - Neuropathic Pain Quality 5a Score at Month 3 Post-Procedure, secondaryOutcomes measure: Change from Baseline in PROMIS - Neuropathic Pain Quality 5a Score at Month 6 Post-Procedure, secondaryOutcomes measure: Change from Baseline in PROMIS - Neuropathic Pain Quality 5a Score at Month 12 Post-Procedure, secondaryOutcomes measure: Change from Baseline in PROMIS - Neuropathic Pain Quality 5a Score at Month 18 Post-Procedure, secondaryOutcomes measure: Change from Baseline in PROMIS - Sleep Disturbance - Short Form 6a Score at Month 3 Post-Procedure, secondaryOutcomes measure: Change from Baseline in PROMIS - Sleep Disturbance - Short Form 6a Score at Month 6 Post-Procedure, secondaryOutcomes measure: Change from Baseline in PROMIS - Sleep Disturbance - Short Form 6a Score at Month 12 Post-Procedure, secondaryOutcomes measure: Change from Baseline in PROMIS - Sleep Disturbance - Short Form 6a Score at Month 18 Post-Procedure, secondaryOutcomes measure: Change from Baseline in PROMIS - Fatigue - Short Form 6a Score at Month 3 Post-Procedure, secondaryOutcomes measure: Change from Baseline in PROMIS - Fatigue - Short Form 6a Score at Month 6 Post-Procedure, secondaryOutcomes measure: Change from Baseline in PROMIS - Fatigue - Short Form 6a Score at Month 12 Post-Procedure, secondaryOutcomes measure: Change from Baseline in PROMIS - Fatigue - Short Form 6a Score at Month 18 Post-Procedure, secondaryOutcomes measure: Change from Baseline in Pain Catastrophizing Scale (PCS) Score at Month 3 Post-Procedure, secondaryOutcomes measure: Change from Baseline in PCS Score at Month 6 Post-Procedure, secondaryOutcomes measure: Change from Baseline in PCS Score at Month 12 Post-Procedure, secondaryOutcomes measure: Change from Baseline in PCS Score at Month 18 Post-Procedure, secondaryOutcomes measure: Change from Baseline in Sleep Duration at Month 3 Post-Procedure, secondaryOutcomes measure: Change from Baseline in Sleep Duration at Month 6 Post-Procedure, secondaryOutcomes measure: Change from Baseline in Sleep Duration at Month 12 Post-Procedure, secondaryOutcomes measure: Change from Baseline in Sleep Duration at Month 18 Post-Procedure, secondaryOutcomes measure: Change from Baseline in Tobacco, Alcohol, Prescription medications, and other Substance (TAPS) Score at Month 3 Post-Procedure, secondaryOutcomes measure: Change from Baseline in TAPS Score at Month 6 Post-Procedure, secondaryOutcomes measure: Change from Baseline in TAPS Score at Month 12 Post-Procedure, secondaryOutcomes measure: Change from Baseline in TAPS Score at Month 18 Post-Procedure, secondaryOutcomes measure: Change from Baseline in Patient Global Impression of Change (PGIC) Score at Month 3 Post-Procedure, secondaryOutcomes measure: Change from Baseline in PGIC Score at Month 6 Post-Procedure, secondaryOutcomes measure: Change from Baseline in PGIC Score at Month 12 Post-Procedure, secondaryOutcomes measure: Change from Baseline in PGIC Score at Month 18 Post-Procedure, secondaryOutcomes measure: Change from Baseline in Patient Health Questionnaire-2 (PHQ-2) Score at Month 3 Post-Procedure, secondaryOutcomes measure: Change from Baseline in PHQ-2 Score at Month 6 Post-Procedure, secondaryOutcomes measure: Change from Baseline in PHQ-2 Score at Month 12 Post-Procedure, secondaryOutcomes measure: Change from Baseline in PHQ-2 Score at Month 18 Post-Procedure, secondaryOutcomes measure: Change from Baseline in Generalized Anxiety Disorder 2 (GAD-2) Score at Month 3 Post-Procedure, secondaryOutcomes measure: Change from Baseline in GAD-2 Score at Month 6 Post-Procedure, secondaryOutcomes measure: Change from Baseline in GAD-2 Score at Month 12 Post-Procedure, secondaryOutcomes measure: Change from Baseline in GAD-2 Score at Month 18 Post-Procedure, secondaryOutcomes measure: Change from Baseline in Pain, Enjoyment of Life and General Activity (PEG) Scale at Month 3 Post-Procedure, secondaryOutcomes measure: Change from Baseline in PEG Scale at Month 6 Post-Procedure, secondaryOutcomes measure: Change from Baseline in PEG Scale at Month 12 Post-Procedure, secondaryOutcomes measure: Change from Baseline in PEG Scale at Month 18 Post-Procedure, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: NYU Langone Health, status: RECRUITING, city: New York, state: New York, zip: 10016, country: United States, geoPoint lat: 40.71427, lon: -74.00597, hasResults: False