Predictive Biomarker for Endoscopic Therapy in Chronic Pancreatitis

NCT06267365 | Recruiting

• 1 other identifier: 23-00766
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pancreatitis

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Brief Pain Inventory (BPI) Score at Month 3 Post-Operation

  BPI is a 9-item assessment of pain. Each item is rated on a Likert scale from 0 (No Pain) to 10 (Pain as bad as you can imagine). The total score is the sum of responses and ranges from 0-90; higher scores indicate greater pain.

  Baseline, Month 3 Post-Operation

Secondary Outcomes (60)

• Change from Baseline in BPI Score at Month 6 Post-Operation

  Baseline, Month 6 Post-Operation

• Change from Baseline in BPI Score at Month 12 Post-Operation

  Baseline, Month 12 Post-Operation

• Change from Baseline in BPI Score at Month 18 Post-Operation

  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

  Baseline, Month 3 Post-Operation

• Change from Baseline in PROMIS - Physical Function - Short Form 6b Score at Month 6 Post-Operation

  Baseline, Month 6 Post-Operation

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults older than 18 years with painful chronic pancreatitis scheduled for endoscopic therapy.

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

Sponsors & Collaborators

• NYU Langone Health: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood (plasma/serum).

MeSH Terms

Conditions

Pancreatitis, Chronic

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Tamas Gonda, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

• Lisa Doan, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

• Jing Wang, MD, PhD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa Doan, MD

CONTACT

212-263-5072; Lisa.doan@nyulangone.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2024
• First Posted: February 20, 2024
• Study Start: November 27, 2023
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Lisa.Doan@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)