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Recruiting NCT06267365

Predictive Biomarker for Endoscopic Therapy in Chronic Pancreatitis

Trial Parameters

Condition Chronic Pancreatitis
Sponsor NYU Langone Health
Study Type OBSERVATIONAL
Phase N/A
Enrollment 100
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-11-27
Completion 2027-03-01

Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: * adults older than 18 years; * 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: * chronic pain syndrome other than CP; * 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 o

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