Predictive Biomarker for Endoscopic Therapy in Chronic Pancreatitis

Status: Recruiting
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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).

Locations
United States
New York
NYU Langone Health
RECRUITING
New York
Contact Information
Primary
Lisa Doan, MD
Lisa.doan@nyulangone.org
212-263-5072
Time Frame
Start Date: 2023-11-27
Estimated Completion Date: 2028-06-01
Participants
Target number of participants: 100
Treatments
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.
Sponsors
Leads: NYU Langone Health
Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)

This content was sourced from clinicaltrials.gov