NCT06267365 Predictive Biomarker for Endoscopic Therapy in Chronic Pancreatitis
| NCT ID | NCT06267365 |
| Status | Recruiting |
| Phase | — |
| Sponsor | NYU Langone Health |
| Condition | Chronic Pancreatitis |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-11-27 |
| Primary Completion | 2027-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2023-11-27 with a primary completion date of 2027-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Tamas Gonda, MD
PRINCIPAL INVESTIGATOR
NYU Langone Health
Frequently Asked Questions
Who can join the NCT06267365 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Pancreatitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06267365 currently recruiting?
Yes, NCT06267365 is actively recruiting participants. Contact the research team at Lisa.doan@nyulangone.org for enrollment information.
Where is the NCT06267365 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT06267365 clinical trial?
NCT06267365 is sponsored by NYU Langone Health. The principal investigator is Tamas Gonda, MD at NYU Langone Health. The trial plans to enroll 100 participants.