Predictive Biomarker for Endoscopic Therapy in Chronic Pancreatitis
NCT ID: NCT06267365
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2023-11-27
2028-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Adult Patients with Painful Chronic Pancreatitis
Participants with chronic pancreatitis scheduled for endoscopic therapy will undergo baseline assessments including EEG, quantitative sensory testing, and psychosocial questionnaires. Follow-up questionnaires will be completed at approximately 3, 6, 12 and 18 months post-procedure.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Cambridge III or IV criteria for Chronic Pancreatitis (CP); or M-ANNHEIM criteria for definitive chronic pancreatitis;
* scheduled for endoscopic therapy for ductal obstruction (may include lithotripsy, pancreatic duct dilation, or stone extraction to facilitate successful stenting) as part of routine clinical care based on multidisciplinary review;
* pain present for ≥ 3 days per week for ≥ 3 months;
* average pain over the last week ≥ 4 on a 11-point numeric rating scale (NRS).
Exclusion Criteria
* episode of acute pancreatitis within 2 months of enrollment;
* endoscopic therapy including Endoscopic retrograde cholangiopancreatography (ERCP), Endoscopic ultrasound (EUS) Guided Celiac Plexus Block or pancreatic surgery \< 6 months prior to enrollment;
* active illicit drug use (excludes marijuana use);
* American Society of Anesthesiologists classification \> 3;
* immune-mediated pancreatitis or associated pancreatic neoplasms
* Major neurological disease such as stroke, uncontrolled epilepsy, dementia
* Diagnosis of schizophrenia
* Chronic benzodiazepine use. Use of short acting benzodiazepine on as needed basis is acceptable if participant is able to hold benzodiazepine prior to EEG recording.
* Pregnancy
18 Years
ALL
No
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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Tamas Gonda, MD
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Health
Lisa Doan, MD
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Health
Jing Wang, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Health
Locations
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NYU Langone Health
New York, New York, United States
Countries
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Central Contacts
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Other Identifiers
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23-00766
Identifier Type: -
Identifier Source: org_study_id