Recruiting NCT06267365
Predictive Biomarker for Endoscopic Therapy in Chronic Pancreatitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Chronic Pancreatitis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Primary outcome measures
- Change from Baseline in Brief Pain Inventory (BPI) Score at Month 3 Post-Operation [Time frame: Baseline, Month 3 Post-Operation]
Secondary outcome measures (12)
- Change from Baseline in BPI Score at Month 6 Post-Operation [Time frame: Baseline, Month 6 Post-Operation]
- Change from Baseline in BPI Score at Month 12 Post-Operation [Time frame: Baseline, Month 12 Post-Operation]
- Change from Baseline in BPI Score at Month 18 Post-Operation [Time frame: Baseline, Month 18 Post-Operation]
- Change from Baseline in Patient Reported Outcome System (PROMIS) - Physical Function - Short Form 6b Score at Month 3 Post-Operation [Time frame: Baseline, Month 3 Post-Operation]
- Change from Baseline in PROMIS - Physical Function - Short Form 6b Score at Month 6 Post-Operation [Time frame: Baseline, Month 6 Post-Operation]
- Change from Baseline in PROMIS - Physical Function - Short Form 6b Score at Month 12 Post-Operation [Time frame: Baseline, Month 12 Post-Operation]
- Change from Baseline in PROMIS - Physical Function - Short Form 6b Score at Month 18 Post-Operation [Time frame: Baseline, Month 18 Post-Operation]
- Number of Participants who use Opioids at Baseline [Time frame: Baseline]
- Number of Participants who use Opioids at Month 3 [Time frame: Month 3]
- Number of Participants who use Opioids at Month 6 [Time frame: Month 6]
- Number of Participants who use Opioids at Month 12 [Time frame: Month 12]
- Number of Participants who use Opioids at Month 18 [Time frame: Month 18]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- NYU Langone Health — New York
Identifiers
NCT: NCT06267365 · 23-00766