Predictive Biomarker for Endoscopic Therapy in Chronic Pancreatitis

Description

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 Overview

Study Details

Study overview

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.

Predictive Biomarker for Endoscopic Therapy in Chronic Pancreatitis

Predictive Biomarker for Endoscopic Therapy in Chronic Pancreatitis

Condition
Chronic Pancreatitis
Intervention / Treatment

-

Contacts and Locations

New York

NYU Langone Health, New York, New York, United States, 10016

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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).
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

NYU Langone Health,

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

Study Record Dates

2025-09-01