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

Predictive Biomarker for Endoscopic Therapy in Chronic Pancreatitis

This study is testing if certain biological markers can help predict how well people with chronic pancreatitis will respond to endoscopic therapy for pain relief.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: NYU Langone Health (Academic / other)
• Locations: 1 site (New York, New York)
• Trial ID: NCT06267365 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 with chronic pancreatitis who experience significant pain and are scheduled for endoscopic therapy.

Not a fit: Patients with chronic pain syndromes unrelated to chronic pancreatitis or those who have had recent acute pancreatitis episodes may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more personalized treatment approaches for chronic pancreatitis, improving pain management for patients.

How similar studies have performed: While there have been studies on pain management in chronic pancreatitis, the specific approach of developing predictive biomarkers for endoscopic therapy response is relatively novel.

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 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 this trial is running

New York, New York

• 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

Conditions Chronic Pancreatitis