Identifying biomarkers for pain response in chronic pancreatitis patients undergoing endoscopic therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to develop predictive biomarkers that can indicate how patients with chronic pancreatitis will respond to endoscopic therapy. Participants over 18 years old, who meet specific criteria for chronic pancreatitis and are scheduled for endoscopic procedures, will undergo various assessments including EEG, quantitative sensory testing, and psychosocial questionnaires. Their response to the therapy will be evaluated at multiple time points post-procedure, allowing researchers to correlate biomarkers with pain relief outcomes.

Why it matters

Who can join: the full rules

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 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

Where it's running

• NYU Langone Health
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Tamas Gonda, MD — NYU Langone Health
• Study coordinator: Lisa Doan, MD
• Email: Lisa.doan@nyulangone.org
• Phone: 212-263-5072

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.