Predictive Biomarker for Endoscopic Therapy in Chronic Pancreatitis
Recruiting now
Conditions studied: Chronic Pancreatitis
In brief
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.
Key facts
- Study ID
- NCT06267365
- Run by
- NYU Langone Health
- People needed
- 100
- Starts
- 2023-11-27
- Expected to finish
- 2028-06-01
- Last updated by the study team
- 2025-12-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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 it is running
- NYU Langone Health — New York, New York, United States (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.