Clinical trial NCT06267365: Predictive Biomarker for Endoscopic Therapy in Chronic Pancreatitis
Official title: Predictive Biomarker for Endoscopic Therapy in Chronic Pancreatitis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Pancreatitis
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2024-02-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults older than 18 years with painful chronic pancreatitis scheduled for endoscopic therapy.

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

Primary outcomes:
measure: Change from Baseline in Brief Pain Inventory (BPI) Score at Month 3 Post-Operation
timeFrame: Baseline, Month 3 Post-Operation
Secondary outcomes:
measure: Change from Baseline in BPI Score at Month 6 Post-Operation
timeFrame: Baseline, Month 6 Post-Operation
measure: Change from Baseline in BPI Score at Month 12 Post-Operation
timeFrame: Baseline, Month 12 Post-Operation
measure: Change from Baseline in BPI Score at Month 18 Post-Operation
timeFrame: Baseline, Month 18 Post-Operation
measure: Change from Baseline in Patient Reported Outcome System (PROMIS) - Physical Function - Short Form 6b Score at Month 3 Post-Operation
timeFrame: Baseline, Month 3 Post-Operation
measure: Change from Baseline in PROMIS - Physical Function - Short Form 6b Score at Month 6 Post-Operation
timeFrame: Baseline, Month 6 Post-Operation
measure: Change from Baseline in PROMIS - Physical Function - Short Form 6b Score at Month 12 Post-Operation
timeFrame: Baseline, Month 12 Post-Operation
measure: Change from Baseline in PROMIS - Physical Function - Short Form 6b Score at Month 18 Post-Operation
timeFrame: Baseline, Month 18 Post-Operation
measure: Number of Participants who use Opioids at Baseline
timeFrame: Baseline
measure: Number of Participants who use Opioids at Month 3
timeFrame: Month 3
measure: Number of Participants who use Opioids at Month 6
timeFrame: Month 6
measure: Number of Participants who use Opioids at Month 12
timeFrame: Month 12
measure: Number of Participants who use Opioids at Month 18
timeFrame: Month 18
measure: Change from Baseline in PROMIS - Depression - Short Form 4a Score at Month 3 Post-Procedure
timeFrame: Baseline, Month 3 Post-Procedure
measure: Change from Baseline in PROMIS - Depression - Short Form 4a Score at Month 6 Post-Procedure
timeFrame: Baseline, Month 6 Post-Procedure
measure: Change from Baseline in PROMIS - Depression - Short Form 4a Score at Month 12 Post-Procedure
timeFrame: Baseline, Month 12 Post-Procedure
measure: Change from Baseline in PROMIS - Depression - Short Form 4a Score at Month 18 Post-Procedure
timeFrame: Baseline, Month 18 Post-Procedure
measure: Change from Baseline in PROMIS - Anxiety- Short Form 4a Score at Month 3 Post-Procedure
timeFrame: Baseline, Month 3 Post-Procedure
measure: Change from Baseline in PROMIS - Anxiety- Short Form 4a Score at Month 6 Post-Procedure
timeFrame: Baseline, Month 6 Post-Procedure
measure: Change from Baseline in PROMIS - Anxiety- Short Form 4a Score at Month 12 Post-Procedure
timeFrame: Baseline, Month 12 Post-Procedure
measure: Change from Baseline in PROMIS - Anxiety- Short Form 4a Score at Month 18 Post-Procedure
timeFrame: Baseline, Month 18 Post-Procedure
measure: Change from Baseline in PROMIS - Neuropathic Pain Quality 5a Score at Month 3 Post-Procedure
timeFrame: Baseline, Month 3 Post-Procedure
measure: Change from Baseline in PROMIS - Neuropathic Pain Quality 5a Score at Month 6 Post-Procedure
timeFrame: Baseline, Month 6 Post-Procedure
measure: Change from Baseline in PROMIS - Neuropathic Pain Quality 5a Score at Month 12 Post-Procedure
timeFrame: Baseline, Month 12 Post-Procedure
measure: Change from Baseline in PROMIS - Neuropathic Pain Quality 5a Score at Month 18 Post-Procedure
timeFrame: Baseline, Month 18 Post-Procedure
measure: Change from Baseline in PROMIS - Sleep Disturbance - Short Form 6a Score at Month 3 Post-Procedure
timeFrame: Baseline, Month 3 Post-Procedure
measure: Change from Baseline in PROMIS - Sleep Disturbance - Short Form 6a Score at Month 6 Post-Procedure
timeFrame: Baseline, Month 6 Post-Procedure
measure: Change from Baseline in PROMIS - Sleep Disturbance - Short Form 6a Score at Month 12 Post-Procedure
timeFrame: Baseline, Month 12 Post-Procedure
measure: Change from Baseline in PROMIS - Sleep Disturbance - Short Form 6a Score at Month 18 Post-Procedure
timeFrame: Baseline, Month 18 Post-Procedure
measure: Change from Baseline in PROMIS - Fatigue - Short Form 6a Score at Month 3 Post-Procedure
timeFrame: Baseline, Month 3 Post-Procedure
measure: Change from Baseline in PROMIS - Fatigue - Short Form 6a Score at Month 6 Post-Procedure
timeFrame: Baseline, Month 6 Post-Procedure
measure: Change from Baseline in PROMIS - Fatigue - Short Form 6a Score at Month 12 Post-Procedure
timeFrame: Baseline, Month 12 Post-Procedure
measure: Change from Baseline in PROMIS - Fatigue - Short Form 6a Score at Month 18 Post-Procedure
timeFrame: Baseline, Month 18 Post-Procedure
measure: Change from Baseline in Pain Catastrophizing Scale (PCS) Score at Month 3 Post-Procedure
timeFrame: Baseline, Month 3 Post-Procedure
measure: Change from Baseline in PCS Score at Month 6 Post-Procedure
timeFrame: Baseline, Month 6 Post-Procedure
measure: Change from Baseline in PCS Score at Month 12 Post-Procedure
timeFrame: Baseline, Month 12 Post-Procedure
measure: Change from Baseline in PCS Score at Month 18 Post-Procedure
timeFrame: Baseline, Month 18 Post-Procedure
measure: Change from Baseline in Sleep Duration at Month 3 Post-Procedure
timeFrame: Baseline, Month 3 Post-Procedure
measure: Change from Baseline in Sleep Duration at Month 6 Post-Procedure
timeFrame: Baseline, Month 6 Post-Procedure
measure: Change from Baseline in Sleep Duration at Month 12 Post-Procedure
timeFrame: Baseline, Month 12 Post-Procedure
measure: Change from Baseline in Sleep Duration at Month 18 Post-Procedure
timeFrame: Baseline, Month 18 Post-Procedure
measure: Change from Baseline in Tobacco, Alcohol, Prescription medications, and other Substance (TAPS) Score at Month 3 Post-Procedure
timeFrame: Baseline, Month 3 Post-Procedure
measure: Change from Baseline in TAPS Score at Month 6 Post-Procedure
timeFrame: Baseline, Month 6 Post-Procedure
measure: Change from Baseline in TAPS Score at Month 12 Post-Procedure
timeFrame: Baseline, Month 12 Post-Procedure
measure: Change from Baseline in TAPS Score at Month 18 Post-Procedure
timeFrame: Baseline, Month 18 Post-Procedure
measure: Change from Baseline in Patient Global Impression of Change (PGIC) Score at Month 3 Post-Procedure
timeFrame: Baseline, Month 3 Post-Procedure
measure: Change from Baseline in PGIC Score at Month 6 Post-Procedure
timeFrame: Baseline, Month 6 Post-Procedure
measure: Change from Baseline in PGIC Score at Month 12 Post-Procedure
timeFrame: Baseline, Month 12 Post-Procedure
measure: Change from Baseline in PGIC Score at Month 18 Post-Procedure
timeFrame: Baseline, Month 18 Post-Procedure
measure: Change from Baseline in Patient Health Questionnaire-2 (PHQ-2) Score at Month 3 Post-Procedure
timeFrame: Baseline, Month 3 Post-Procedure
measure: Change from Baseline in PHQ-2 Score at Month 6 Post-Procedure
timeFrame: Baseline, Month 6 Post-Procedure
measure: Change from Baseline in PHQ-2 Score at Month 12 Post-Procedure
timeFrame: Baseline, Month 12 Post-Procedure
measure: Change from Baseline in PHQ-2 Score at Month 18 Post-Procedure
timeFrame: Baseline, Month 18 Post-Procedure
measure: Change from Baseline in Generalized Anxiety Disorder 2 (GAD-2) Score at Month 3 Post-Procedure
timeFrame: Baseline, Month 3 Post-Procedure
measure: Change from Baseline in GAD-2 Score at Month 6 Post-Procedure
timeFrame: Baseline, Month 6 Post-Procedure
measure: Change from Baseline in GAD-2 Score at Month 12 Post-Procedure
timeFrame: Baseline, Month 12 Post-Procedure
measure: Change from Baseline in GAD-2 Score at Month 18 Post-Procedure
timeFrame: Baseline, Month 18 Post-Procedure
measure: Change from Baseline in Pain, Enjoyment of Life and General Activity (PEG) Scale at Month 3 Post-Procedure
timeFrame: Baseline, Month 3 Post-Procedure
measure: Change from Baseline in PEG Scale at Month 6 Post-Procedure
timeFrame: Baseline, Month 6 Post-Procedure
measure: Change from Baseline in PEG Scale at Month 12 Post-Procedure
timeFrame: Baseline, Month 12 Post-Procedure
measure: Change from Baseline in PEG Scale at Month 18 Post-Procedure
timeFrame: Baseline, Month 18 Post-Procedure
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Tamas Gonda, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: NYU Langone Health
name: Lisa Doan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: NYU Langone Health
name: Jing Wang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: