Predictive Biomarker for Endoscopic Therapy in Chronic Pancreatitis

NYU Langone Health

Status: Enrolling

Conditions: Chronic Pancreatitis

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT06267365

23-00766

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adults older than 18 years;
• Cambridge III or IV criteria for 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 ERCP, 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

Trial design

100 participants in 1 patient group

Adult Patients with Painful Chronic Pancreatitis

Description:

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.