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Predicting Pain Response to Endoscopic Therapy in Chronic Pancreatitis

This study is looking for adults with chronic pancreatitis (a long-lasting inflammation of the pancreas) who are scheduled to have endoscopic therapy. Endoscopic therapy involves procedures like lithotripsy (breaking up stones), pancreatic duct dilation (widening the pancreatic duct), or stone extraction to help with blockages. The goal is to find ways to predict how well a person's pain will improve after this treatment. Researchers will collect information like brain wave activity (electroencephalography or EEG), how you sense touch and pain (quantitative sensory testing or QST), and answers to questions about your feelings and social life before your procedure. Your pain levels will then be checked at 3, 6, 12, and 18 months after your procedure.

Study design
This is an observational study, meaning researchers will observe participants without giving them a specific intervention. About 100 participants are planned for this study.
What's involved
You would have baseline assessments including EEG, QST, and psychosocial questionnaires. Your response to endoscopic therapy will be assessed using questionnaires at 3, 6, 12, and 18 months after your procedure.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for approximately 18 months after their endoscopic therapy.

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NCT06267365

Predictive Biomarker for Endoscopic Therapy in Chronic Pancreatitis

Recruiting
Not specifiedAges 18+Observational
NYU Langone Health
~100 participants
Updated 2025-12-17 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from Baseline in Brief Pain Inventory (BPI) Score at Month 3 Post-Operation
Measured over Baseline, Month 3 Post-Operation

Conditions

Chronic Pancreatitis

Explore related trials

Chronic Pancreatitis

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Tamas Gonda, MD · PRINCIPAL_INVESTIGATOR · NYU Langone Health
  • Lisa Doan, MD · PRINCIPAL_INVESTIGATOR · NYU Langone Health
  • Jing Wang, MD, PhD · PRINCIPAL_INVESTIGATOR · NYU Langone Health

Who to contact

Lisa Doan, MD
[email protected]
212-263-5072
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Change from Baseline in Brief Pain Inventory (BPI) Score at Month 3 Post-OperationBaseline, Month 3 Post-Operation

    BPI is a 9-item assessment of pain. Each item is rated on a Likert scale from 0 (No Pain) to 10 (Pain as bad as you can imagine). The total score is the sum of responses and ranges from 0-90; higher scores indicate greater pain.