RecruitingNCT06267365

Predictive Biomarker for Endoscopic Therapy in Chronic Pancreatitis

Sponsor

NYU Langone Health

Enrollment

100 participants

Start Date

Nov 27, 2023

Study Type

OBSERVATIONAL

Conditions

Chronic Pancreatitis

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

Min Age: 18 Years

Inclusion Criteria5

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 Criteria10

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 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