RECRUITING

Predictive Biomarker for Endoscopic Therapy in Chronic Pancreatitis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Predictive Biomarker for Endoscopic Therapy in Chronic Pancreatitis

Quick Facts

Study Start:2023-11-27

Study Completion:2025-09-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06267365

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* adults older than 18 years; * Cambridge III or IV criteria for 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).	* chronic pain syndrome other than CP; * episode of acute pancreatitis within 2 months of enrollment; * endoscopic therapy including ERCP, 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

Inclusion Criteria

Exclusion Criteria

* adults older than 18 years;
* Cambridge III or IV criteria for 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).

* chronic pain syndrome other than CP;
* episode of acute pancreatitis within 2 months of enrollment;
* endoscopic therapy including ERCP, 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

Contacts and Locations

Study Contact

Lisa Doan, MD

CONTACT

212-263-5072

Lisa.doan@nyulangone.org

Principal Investigator

Tamas Gonda, MD

PRINCIPAL_INVESTIGATOR

NYU Langone Health

Lisa Doan, MD

PRINCIPAL_INVESTIGATOR

NYU Langone Health

Jing Wang, MD, PhD

PRINCIPAL_INVESTIGATOR

NYU Langone Health

Study Locations (Sites)

NYU Langone Health

New York, New York, 10016

United States

Collaborators and Investigators

Sponsor: NYU Langone Health

Tamas Gonda, MD, PRINCIPAL_INVESTIGATOR, NYU Langone Health
Lisa Doan, MD, PRINCIPAL_INVESTIGATOR, NYU Langone Health
Jing Wang, MD, PhD, PRINCIPAL_INVESTIGATOR, NYU Langone Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-27

Study Completion Date2025-09-01

Study Record Updates

Study Start Date2023-11-27

Study Completion Date2025-09-01

Terms related to this study

Additional Relevant MeSH Terms

Chronic Pancreatitis