Recruiting

Predictive Biomarker

Sponsor:

NYU Langone Health

Code:

NCT06267365

Conditions

Chronic Pancreatitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

Chronic Pancreatitis

Study ID

NCT06267365

Start date

Nov 27, 2023

Status verified date

Dec, 2025

Completion date

Jun 1, 2028

Anticipated

Primary completion date

Mar 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Adult Patients with Painful Chronic Pancreatitis

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.

Primary outcome measure

  • Change from Baseline in Brief Pain Inventory (BPI) Score at Month 3 Post-Operation [ Time Frame: Baseline, Month 3 Post-Operation ]

Central Contacts and Locations

Central contacts

Lisa Doan, MD

212-263-5072Lisa.doan@nyulangone.org

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

More Information

Sponsor

NYU Langone Health

Last update posted

Dec 17, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2025-12-17.