Chronic PancreatitisNCT06267365

Predictive Biomarker for Endoscopic Therapy in Chronic Pancreatitis

An observational study of Chronic Pancreatitis, run by NYU Langone Health at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Pancreatitis
How many people: 100 participants
Where: 1 siteUnited States
Study dates: 27 Nov 2023to 1 Jun 2028
Phase: Observational
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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

Who may be able to join

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).

Who cannot join

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

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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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Lisa Doan, MD contact

212-263-5072

Lisa.doan@nyulangone.org

United States1 site, 1 recruiting

NYU Langone Health
New York, New York, 10016
Recruiting

Other trials in United States

About this study

Conditions: Chronic Pancreatitis
Medical subject headings: Pancreatitis, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06267365
Study group	Role	What they receive
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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline, Month 3 Post-Operation

Secondary outcomes (60)

Change from Baseline in BPI Score at Month 6 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.
Measured: Baseline, Month 6 Post-Operation
Change from Baseline in BPI Score at Month 12 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.
Measured: Baseline, Month 12 Post-Operation
Change from Baseline in BPI Score at Month 18 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.
Measured: 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
The PROMIS Physical Function Short Form 6b comprises 6 questions assessing general physical function. Each item is rated on a Likert scale from 1 (Unable to do) to 5 (Without any difficulty). The raw score is the sum of responses and is transformed into a T-score a mean of 50 and standard deviation of 10. Scores range from 0-100; higher scores indicate greater physical function.
Measured: Baseline, Month 3 Post-Operation
Change from Baseline in PROMIS - Physical Function - Short Form 6b Score at Month 6 Post-Operation
The PROMIS Physical Function Short Form 6b comprises 6 questions assessing general physical function. Each item is rated on a Likert scale from 1 (Unable to do) to 5 (Without any difficulty). The raw score is the sum of responses and is transformed into a T-score a mean of 50 and standard deviation of 10. Scores range from 0-100; higher scores indicate greater physical function.
Measured: Baseline, Month 6 Post-Operation
Change from Baseline in PROMIS - Physical Function - Short Form 6b Score at Month 12 Post-Operation
The PROMIS Physical Function Short Form 6b comprises 6 questions assessing general physical function. Each item is rated on a Likert scale from 1 (Unable to do) to 5 (Without any difficulty). The raw score is the sum of responses and is transformed into a T-score a mean of 50 and standard deviation of 10. Scores range from 0-100; higher scores indicate greater physical function.
Measured: Baseline, Month 12 Post-Operation
Change from Baseline in PROMIS - Physical Function - Short Form 6b Score at Month 18 Post-Operation
The PROMIS Physical Function Short Form 6b comprises 6 questions assessing general physical function. Each item is rated on a Likert scale from 1 (Unable to do) to 5 (Without any difficulty). The raw score is the sum of responses and is transformed into a T-score a mean of 50 and standard deviation of 10. Scores range from 0-100; higher scores indicate greater physical function.
Measured: Baseline, Month 18 Post-Operation
Number of Participants who use Opioids at Baseline
Measured: Baseline
Number of Participants who use Opioids at Month 3
Measured: Month 3
Number of Participants who use Opioids at Month 6
Measured: Month 6
Number of Participants who use Opioids at Month 12
Measured: Month 12
Number of Participants who use Opioids at Month 18
Measured: Month 18
Change from Baseline in PROMIS - Depression - Short Form 4a Score at Month 3 Post-Procedure
The PROMIS Depression - Short Form 4a is a 4-item assessment of symptoms of depression in the past 7 days. Items are ranked on a Likert scale from 1 (never) to 5 (always). The raw score is the sum of responses and is transformed into a T-score a mean of 50 and standard deviation of 10. Scores range from 0-100; higher scores indicate greater prevalence of depressive symptoms.
Measured: Baseline, Month 3 Post-Procedure
Change from Baseline in PROMIS - Depression - Short Form 4a Score at Month 6 Post-Procedure
The PROMIS Depression - Short Form 4a is a 4-item assessment of symptoms of depression in the past 7 days. Items are ranked on a Likert scale from 1 (never) to 5 (always). The raw score is the sum of responses and is transformed into a T-score a mean of 50 and standard deviation of 10. Scores range from 0-100; higher scores indicate greater prevalence of depressive symptoms.
Measured: Baseline, Month 6 Post-Procedure
Change from Baseline in PROMIS - Depression - Short Form 4a Score at Month 12 Post-Procedure
The PROMIS Depression - Short Form 4a is a 4-item assessment of symptoms of depression in the past 7 days. Items are ranked on a Likert scale from 1 (never) to 5 (always). The raw score is the sum of responses and is transformed into a T-score a mean of 50 and standard deviation of 10. Scores range from 0-100; higher scores indicate greater prevalence of depressive symptoms.
Measured: Baseline, Month 12 Post-Procedure
Change from Baseline in PROMIS - Depression - Short Form 4a Score at Month 18 Post-Procedure
The PROMIS Depression - Short Form 4a is a 4-item assessment of symptoms of depression in the past 7 days. Items are ranked on a Likert scale from 1 (never) to 5 (always). The raw score is the sum of responses and is transformed into a T-score a mean of 50 and standard deviation of 10. Scores range from 0-100; higher scores indicate greater prevalence of depressive symptoms.
Measured: Baseline, Month 18 Post-Procedure
Change from Baseline in PROMIS - Anxiety- Short Form 4a Score at Month 3 Post-Procedure
The PROMIS Anxiety- Short Form 4a is a 4-item assessment of symptoms of anxiety in the past 7 days. Items are ranked on a Likert scale from 1 (never) to 5 (always). The raw score is the sum of responses and is transformed into a T-score a mean of 50 and standard deviation of 10. Scores range from 0-100; higher scores indicate greater prevalence of anxiety.
Measured: Baseline, Month 3 Post-Procedure
Change from Baseline in PROMIS - Anxiety- Short Form 4a Score at Month 6 Post-Procedure
The PROMIS Anxiety- Short Form 4a is a 4-item assessment of symptoms of anxiety in the past 7 days. Items are ranked on a Likert scale from 1 (never) to 5 (always). The raw score is the sum of responses and is transformed into a T-score a mean of 50 and standard deviation of 10. Scores range from 0-100; higher scores indicate greater prevalence of anxiety.
Measured: Baseline, Month 6 Post-Procedure
Change from Baseline in PROMIS - Anxiety- Short Form 4a Score at Month 12 Post-Procedure
The PROMIS Anxiety- Short Form 4a is a 4-item assessment of symptoms of anxiety in the past 7 days. Items are ranked on a Likert scale from 1 (never) to 5 (always). The raw score is the sum of responses and is transformed into a T-score a mean of 50 and standard deviation of 10. Scores range from 0-100; higher scores indicate greater prevalence of anxiety.
Measured: Baseline, Month 12 Post-Procedure
Change from Baseline in PROMIS - Anxiety- Short Form 4a Score at Month 18 Post-Procedure
The PROMIS Anxiety- Short Form 4a is a 4-item assessment of symptoms of anxiety in the past 7 days. Items are ranked on a Likert scale from 1 (never) to 5 (always). The raw score is the sum of responses and is transformed into a T-score a mean of 50 and standard deviation of 10. Scores range from 0-100; higher scores indicate greater prevalence of anxiety.
Measured: Baseline, Month 18 Post-Procedure
Change from Baseline in PROMIS - Neuropathic Pain Quality 5a Score at Month 3 Post-Procedure
The PROMIS Neuropathic Pain Quality 5a is a 5-item assessment of symptoms of neuropathic pain in the past 7 days. Items are ranked on a Likert scale from 1 (not at all) to 5 (very much). The raw score is the sum of responses and is transformed into a T-score a mean of 50 and standard deviation of 10. Scores range from 0-100; higher scores indicate greater prevalence of neuropathic pain.
Measured: Baseline, Month 3 Post-Procedure
Change from Baseline in PROMIS - Neuropathic Pain Quality 5a Score at Month 6 Post-Procedure
The PROMIS Neuropathic Pain Quality 5a is a 5-item assessment of symptoms of neuropathic pain in the past 7 days. Items are ranked on a Likert scale from 1 (not at all) to 5 (very much). The raw score is the sum of responses and is transformed into a T-score a mean of 50 and standard deviation of 10. Scores range from 0-100; higher scores indicate greater prevalence of neuropathic pain.
Measured: Baseline, Month 6 Post-Procedure
Change from Baseline in PROMIS - Neuropathic Pain Quality 5a Score at Month 12 Post-Procedure
The PROMIS Neuropathic Pain Quality 5a is a 5-item assessment of symptoms of neuropathic pain in the past 7 days. Items are ranked on a Likert scale from 1 (not at all) to 5 (very much). The raw score is the sum of responses and is transformed into a T-score a mean of 50 and standard deviation of 10. Scores range from 0-100; higher scores indicate greater prevalence of neuropathic pain.
Measured: Baseline, Month 12 Post-Procedure
Change from Baseline in PROMIS - Neuropathic Pain Quality 5a Score at Month 18 Post-Procedure
The PROMIS Neuropathic Pain Quality 5a is a 5-item assessment of symptoms of neuropathic pain in the past 7 days. Items are ranked on a Likert scale from 1 (not at all) to 5 (very much). The raw score is the sum of responses and is transformed into a T-score a mean of 50 and standard deviation of 10. Scores range from 0-100; higher scores indicate greater prevalence of neuropathic pain.
Measured: Baseline, Month 18 Post-Procedure
Change from Baseline in PROMIS - Sleep Disturbance - Short Form 6a Score at Month 3 Post-Procedure
The PROMIS Sleep Disturbance - Short Form 6a is a 6-item assessment of sleep disturbance in the past 7 days. Items are ranked on a Likert scale from 1-5. The raw score is the sum of responses and is transformed into a T-score a mean of 50 and standard deviation of 10. Scores range from 0-100; higher scores indicate greater prevalence of sleep disturbance.
Measured: Baseline, Month 3 Post-Procedure
Change from Baseline in PROMIS - Sleep Disturbance - Short Form 6a Score at Month 6 Post-Procedure
The PROMIS Sleep Disturbance - Short Form 6a is a 6-item assessment of sleep disturbance in the past 7 days. Items are ranked on a Likert scale from 1-5. The raw score is the sum of responses and is transformed into a T-score a mean of 50 and standard deviation of 10. Scores range from 0-100; higher scores indicate greater prevalence of sleep disturbance.
Measured: Baseline, Month 6 Post-Procedure
Change from Baseline in PROMIS - Sleep Disturbance - Short Form 6a Score at Month 12 Post-Procedure
The PROMIS Sleep Disturbance - Short Form 6a is a 6-item assessment of sleep disturbance in the past 7 days. Items are ranked on a Likert scale from 1-5. The raw score is the sum of responses and is transformed into a T-score a mean of 50 and standard deviation of 10. Scores range from 0-100; higher scores indicate greater prevalence of sleep disturbance.
Measured: Baseline, Month 12 Post-Procedure
Change from Baseline in PROMIS - Sleep Disturbance - Short Form 6a Score at Month 18 Post-Procedure
The PROMIS Sleep Disturbance - Short Form 6a is a 6-item assessment of sleep disturbance in the past 7 days. Items are ranked on a Likert scale from 1-5. The raw score is the sum of responses and is transformed into a T-score a mean of 50 and standard deviation of 10. Scores range from 0-100; higher scores indicate greater prevalence of sleep disturbance.
Measured: Baseline, Month 18 Post-Procedure
Change from Baseline in PROMIS - Fatigue - Short Form 6a Score at Month 3 Post-Procedure
The PROMIS Fatigue - Short Form 6a is a 6-item assessment of fatigue in the past 7 days. Items are ranked on a Likert scale from 1-5. The raw score is the sum of responses and is transformed into a T-score a mean of 50 and standard deviation of 10. Scores range from 0-100; higher scores indicate greater prevalence of fatigue.
Measured: Baseline, Month 3 Post-Procedure
Change from Baseline in PROMIS - Fatigue - Short Form 6a Score at Month 6 Post-Procedure
The PROMIS Fatigue - Short Form 6a is a 6-item assessment of fatigue in the past 7 days. Items are ranked on a Likert scale from 1-5. The raw score is the sum of responses and is transformed into a T-score a mean of 50 and standard deviation of 10. Scores range from 0-100; higher scores indicate greater prevalence of fatigue.
Measured: Baseline, Month 6 Post-Procedure
Change from Baseline in PROMIS - Fatigue - Short Form 6a Score at Month 12 Post-Procedure
The PROMIS Fatigue - Short Form 6a is a 6-item assessment of fatigue in the past 7 days. Items are ranked on a Likert scale from 1-5. The raw score is the sum of responses and is transformed into a T-score a mean of 50 and standard deviation of 10. Scores range from 0-100; higher scores indicate greater prevalence of fatigue.
Measured: Baseline, Month 12 Post-Procedure
Change from Baseline in PROMIS - Fatigue - Short Form 6a Score at Month 18 Post-Procedure
The PROMIS Fatigue - Short Form 6a is a 6-item assessment of fatigue in the past 7 days. Items are ranked on a Likert scale from 1-5. The raw score is the sum of responses and is transformed into a T-score a mean of 50 and standard deviation of 10. Scores range from 0-100; higher scores indicate greater prevalence of fatigue.
Measured: Baseline, Month 18 Post-Procedure
Change from Baseline in Pain Catastrophizing Scale (PCS) Score at Month 3 Post-Procedure
The PCS is a 13-item assessment of the prevalence of thoughts and feelings associated with pain. Each item is rated on a Likert scale from 0 (not at all) to 4 (all the time). The total score is the sum of responses and ranges from 0 to 52; higher scores indicate greater pain catastrophizing.
Measured: Baseline, Month 3 Post-Procedure
Change from Baseline in PCS Score at Month 6 Post-Procedure
The PCS is a 13-item assessment of the prevalence of thoughts and feelings associated with pain. Each item is rated on a Likert scale from 0 (not at all) to 4 (all the time). The total score is the sum of responses and ranges from 0 to 52; higher scores indicate greater pain catastrophizing.
Measured: Baseline, Month 6 Post-Procedure
Change from Baseline in PCS Score at Month 12 Post-Procedure
The PCS is a 13-item assessment of the prevalence of thoughts and feelings associated with pain. Each item is rated on a Likert scale from 0 (not at all) to 4 (all the time). The total score is the sum of responses and ranges from 0 to 52; higher scores indicate greater pain catastrophizing.
Measured: Baseline, Month 12 Post-Procedure
Change from Baseline in PCS Score at Month 18 Post-Procedure
The PCS is a 13-item assessment of the prevalence of thoughts and feelings associated with pain. Each item is rated on a Likert scale from 0 (not at all) to 4 (all the time). The total score is the sum of responses and ranges from 0 to 52; higher scores indicate greater pain catastrophizing.
Measured: Baseline, Month 18 Post-Procedure
Change from Baseline in Sleep Duration at Month 3 Post-Procedure
Measured: Baseline, Month 3 Post-Procedure
Change from Baseline in Sleep Duration at Month 6 Post-Procedure
Measured: Baseline, Month 6 Post-Procedure
Change from Baseline in Sleep Duration at Month 12 Post-Procedure
Measured: Baseline, Month 12 Post-Procedure
Change from Baseline in Sleep Duration at Month 18 Post-Procedure
Measured: Baseline, Month 18 Post-Procedure
Change from Baseline in Tobacco, Alcohol, Prescription medications, and other Substance (TAPS) Score at Month 3 Post-Procedure
TAPS consists of a combined screening component (TAPS-1) followed by a brief followed by a brief assessment (TAPS-2) for those who screen positive. Scores on these questions generate a risk level per substance endorsed, based on a range of possible scores per substance. Scores range from 0-4; higher scores indicate a higher likelihood of problematic substance use.
Measured: Baseline, Month 3 Post-Procedure
Change from Baseline in TAPS Score at Month 6 Post-Procedure
TAPS consists of a combined screening component (TAPS-1) followed by a brief followed by a brief assessment (TAPS-2) for those who screen positive. Scores on these questions generate a risk level per substance endorsed, based on a range of possible scores per substance. Scores range from 0-4; higher scores indicate a higher likelihood of problematic substance use.
Measured: Baseline, Month 6 Post-Procedure
Change from Baseline in TAPS Score at Month 12 Post-Procedure
TAPS consists of a combined screening component (TAPS-1) followed by a brief followed by a brief assessment (TAPS-2) for those who screen positive. Scores on these questions generate a risk level per substance endorsed, based on a range of possible scores per substance. Scores range from 0-4; higher scores indicate a higher likelihood of problematic substance use.
Measured: Baseline, Month 12 Post-Procedure
Change from Baseline in TAPS Score at Month 18 Post-Procedure
TAPS consists of a combined screening component (TAPS-1) followed by a brief followed by a brief assessment (TAPS-2) for those who screen positive. Scores on these questions generate a risk level per substance endorsed, based on a range of possible scores per substance. Scores range from 0-4; higher scores indicate a higher likelihood of problematic substance use.
Measured: Baseline, Month 18 Post-Procedure
Change from Baseline in Patient Global Impression of Change (PGIC) Score at Month 3 Post-Procedure
PGIC is a 1-item assessment of patient's perception of the change in activity limitation, symptoms, emotions and overall quality of life related to their condition since beginning treatment. The item is rated on a scale from 1 (no change) to 7 (a great deal better). The final score is the numerical rating; higher scores indicate greater change.
Measured: Baseline, Month 3 Post-Procedure
Change from Baseline in PGIC Score at Month 6 Post-Procedure
PGIC is a 1-item assessment of patient's perception of the change in activity limitation, symptoms, emotions and overall quality of life related to their condition since beginning treatment. The item is rated on a scale from 1 (no change) to 7 (a great deal better). The final score is the numerical rating; higher scores indicate greater change.
Measured: Baseline, Month 6 Post-Procedure
Change from Baseline in PGIC Score at Month 12 Post-Procedure
PGIC is a 1-item assessment of patient's perception of the change in activity limitation, symptoms, emotions and overall quality of life related to their condition since beginning treatment. The item is rated on a scale from 1 (no change) to 7 (a great deal better). The final score is the numerical rating; higher scores indicate greater change.
Measured: Baseline, Month 12 Post-Procedure
Change from Baseline in PGIC Score at Month 18 Post-Procedure
PGIC is a 1-item assessment of patient's perception of the change in activity limitation, symptoms, emotions and overall quality of life related to their condition since beginning treatment. The item is rated on a scale from 1 (no change) to 7 (a great deal better). The final score is the numerical rating; higher scores indicate greater change.
Measured: Baseline, Month 18 Post-Procedure
Change from Baseline in Patient Health Questionnaire-2 (PHQ-2) Score at Month 3 Post-Procedure
PHQ-2 is a 2-item assessment of patient health in the last 2 weeks. Items are rated on a Likert scale from 0 (not at all) to 3 (nearly every day). The total score is the sum of responses and ranges from 0 to 6; lower scores indicate better health.
Measured: Baseline, Month 3 Post-Procedure
Change from Baseline in PHQ-2 Score at Month 6 Post-Procedure
PHQ-2 is a 2-item assessment of patient health in the last 2 weeks. Items are rated on a Likert scale from 0 (not at all) to 3 (nearly every day). The total score is the sum of responses and ranges from 0 to 6; lower scores indicate better health.
Measured: Baseline, Month 6 Post-Procedure
Change from Baseline in PHQ-2 Score at Month 12 Post-Procedure
PHQ-2 is a 2-item assessment of patient health in the last 2 weeks. Items are rated on a Likert scale from 0 (not at all) to 3 (nearly every day). The total score is the sum of responses and ranges from 0 to 6; lower scores indicate better health.
Measured: Baseline, Month 12 Post-Procedure
Change from Baseline in PHQ-2 Score at Month 18 Post-Procedure
PHQ-2 is a 2-item assessment of patient health in the last 2 weeks. Items are rated on a Likert scale from 0 (not at all) to 3 (nearly every day). The total score is the sum of responses and ranges from 0 to 6; lower scores indicate better health.
Measured: Baseline, Month 18 Post-Procedure
Change from Baseline in Generalized Anxiety Disorder 2 (GAD-2) Score at Month 3 Post-Procedure
GAD-2 is a 2-item assessment of symptoms of anxiety in the past two weeks. Items are rated on a Likert scale from 0 (not at all) to 3 (nearly every day).The total score is the sum of responses and ranges from 0-6; higher scores indicate greater symptoms of anxiety.
Measured: Baseline, Month 3 Post-Procedure
Change from Baseline in GAD-2 Score at Month 6 Post-Procedure
GAD-2 is a 2-item assessment of symptoms of anxiety in the past two weeks. Items are rated on a Likert scale from 0 (not at all) to 3 (nearly every day).The total score is the sum of responses and ranges from 0-6; higher scores indicate greater symptoms of anxiety.
Measured: Baseline, Month 6 Post-Procedure
Change from Baseline in GAD-2 Score at Month 12 Post-Procedure
GAD-2 is a 2-item assessment of symptoms of anxiety in the past two weeks. Items are rated on a Likert scale from 0 (not at all) to 3 (nearly every day).The total score is the sum of responses and ranges from 0-6; higher scores indicate greater symptoms of anxiety.
Measured: Baseline, Month 12 Post-Procedure
Change from Baseline in GAD-2 Score at Month 18 Post-Procedure
GAD-2 is a 2-item assessment of symptoms of anxiety in the past two weeks. Items are rated on a Likert scale from 0 (not at all) to 3 (nearly every day).The total score is the sum of responses and ranges from 0-6; higher scores indicate greater symptoms of anxiety.
Measured: Baseline, Month 18 Post-Procedure
Change from Baseline in Pain, Enjoyment of Life and General Activity (PEG) Scale at Month 3 Post-Procedure
PEG is a 3-item assessment of pain and how it interferes with activities of daily life. Each item is rated on a scale from 0 (does not interfere) to 10 (completely interferes). The total score is the average of the 3 items and ranges from 0-10; higher scores indicate greater pain interference.
Measured: Baseline, Month 3 Post-Procedure
Change from Baseline in PEG Scale at Month 6 Post-Procedure
PEG is a 3-item assessment of pain and how it interferes with activities of daily life. Each item is rated on a scale from 0 (does not interfere) to 10 (completely interferes). The total score is the average of the 3 items and ranges from 0-10; higher scores indicate greater pain interference.
Measured: Baseline, Month 6 Post-Procedure
Change from Baseline in PEG Scale at Month 12 Post-Procedure
PEG is a 3-item assessment of pain and how it interferes with activities of daily life. Each item is rated on a scale from 0 (does not interfere) to 10 (completely interferes). The total score is the average of the 3 items and ranges from 0-10; higher scores indicate greater pain interference.
Measured: Baseline, Month 12 Post-Procedure
Change from Baseline in PEG Scale at Month 18 Post-Procedure
PEG is a 3-item assessment of pain and how it interferes with activities of daily life. Each item is rated on a scale from 0 (does not interfere) to 10 (completely interferes). The total score is the average of the 3 items and ranges from 0-10; higher scores indicate greater pain interference.
Measured: Baseline, Month 18 Post-Procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Nov 20231 Jun 2028

First posted20 Feb 2024
Study start27 Nov 2023
Primary completion1 Mar 2027 (estimated)
Study completion1 Jun 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Chronic PancreatitisStudies of the same condition, open and under way.
More trials run by NYU Langone HealthThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 100 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06267365
Sponsor's protocol ID: 23-00766
Status last verified: Dec 2025
First submitted: 12 Feb 2024
Last updated: 17 Dec 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: As an NIH-HEAL initiative sponsored study, our IPD sharing comply with the Helping to End Addiction Long-term (HEAL) Public Access and Data Sharing Policy. The de-identified participant data will be shared and deposited into the National Institute of Mental Health Data Archive (NIMH) Data Archive (NDA). The NDA provides metadata, study digital object identifier (DOI), and long-term access. This repository is supported by several institutes and centers at the NIH, and datasets are available through a request process. Investigators requesting data must be affiliated with an NIH-recognized research institution that maintains an active Federalwide Assurance (FWA), and complete and submit a Data Use Certification approved by an authorized institutional business official with signature authority. This request will then be reviewed by the NDA Data Access Committee.

Interested in taking part?

Lisa Doan, MD

212-263-5072

Lisa.doan@nyulangone.org

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Study at a glance

From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Predictive Biomarker for Endoscopic Therapy in Chronic Pancreatitis
ClinicalTrials.gov ID: NCT06267365
Acronym / sponsor ID: 23-00766
Conditions: Chronic Pancreatitis
Study type: Observational
Recruitment status: Recruiting
Enrolment: 100 participants (estimated)
Lead sponsor: NYU Langone HealthUniversity, hospital or other
Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)
Study start: 27 Nov 2023 (actual)
Primary completion: 1 Mar 2027 (estimated)
Study completion: 1 Jun 2028 (estimated)
First posted: 20 Feb 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Adults older than 18 years with painful chronic pancreatitis scheduled for endoscopic therapy.

Key inclusion criteria (5 listed)

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).

Key exclusion criteria (10 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Change from Baseline in Brief Pain Inventory (BPI) Score at Month 3 Post-Operation
Time frame: Baseline, 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.

60 secondary outcomes

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
Change from Baseline in PROMIS - Depression - Short Form 4a Score at Month 3 Post-Procedure
Time frame: Baseline, Month 3 Post-Procedure
Change from Baseline in PROMIS - Depression - Short Form 4a Score at Month 6 Post-Procedure
Time frame: Baseline, Month 6 Post-Procedure
Change from Baseline in PROMIS - Depression - Short Form 4a Score at Month 12 Post-Procedure
Time frame: Baseline, Month 12 Post-Procedure
Change from Baseline in PROMIS - Depression - Short Form 4a Score at Month 18 Post-Procedure
Time frame: Baseline, Month 18 Post-Procedure
Change from Baseline in PROMIS - Anxiety- Short Form 4a Score at Month 3 Post-Procedure
Time frame: Baseline, Month 3 Post-Procedure
Change from Baseline in PROMIS - Anxiety- Short Form 4a Score at Month 6 Post-Procedure
Time frame: Baseline, Month 6 Post-Procedure
Change from Baseline in PROMIS - Anxiety- Short Form 4a Score at Month 12 Post-Procedure
Time frame: Baseline, Month 12 Post-Procedure
Change from Baseline in PROMIS - Anxiety- Short Form 4a Score at Month 18 Post-Procedure
Time frame: Baseline, Month 18 Post-Procedure
Change from Baseline in PROMIS - Neuropathic Pain Quality 5a Score at Month 3 Post-Procedure
Time frame: Baseline, Month 3 Post-Procedure
Change from Baseline in PROMIS - Neuropathic Pain Quality 5a Score at Month 6 Post-Procedure
Time frame: Baseline, Month 6 Post-Procedure
Change from Baseline in PROMIS - Neuropathic Pain Quality 5a Score at Month 12 Post-Procedure
Time frame: Baseline, Month 12 Post-Procedure
Change from Baseline in PROMIS - Neuropathic Pain Quality 5a Score at Month 18 Post-Procedure
Time frame: Baseline, Month 18 Post-Procedure
Change from Baseline in PROMIS - Sleep Disturbance - Short Form 6a Score at Month 3 Post-Procedure
Time frame: Baseline, Month 3 Post-Procedure
Change from Baseline in PROMIS - Sleep Disturbance - Short Form 6a Score at Month 6 Post-Procedure
Time frame: Baseline, Month 6 Post-Procedure
Change from Baseline in PROMIS - Sleep Disturbance - Short Form 6a Score at Month 12 Post-Procedure
Time frame: Baseline, Month 12 Post-Procedure
Change from Baseline in PROMIS - Sleep Disturbance - Short Form 6a Score at Month 18 Post-Procedure
Time frame: Baseline, Month 18 Post-Procedure
Change from Baseline in PROMIS - Fatigue - Short Form 6a Score at Month 3 Post-Procedure
Time frame: Baseline, Month 3 Post-Procedure
Change from Baseline in PROMIS - Fatigue - Short Form 6a Score at Month 6 Post-Procedure
Time frame: Baseline, Month 6 Post-Procedure
Change from Baseline in PROMIS - Fatigue - Short Form 6a Score at Month 12 Post-Procedure
Time frame: Baseline, Month 12 Post-Procedure
Change from Baseline in PROMIS - Fatigue - Short Form 6a Score at Month 18 Post-Procedure
Time frame: Baseline, Month 18 Post-Procedure
Change from Baseline in Pain Catastrophizing Scale (PCS) Score at Month 3 Post-Procedure
Time frame: Baseline, Month 3 Post-Procedure
Change from Baseline in PCS Score at Month 6 Post-Procedure
Time frame: Baseline, Month 6 Post-Procedure
Change from Baseline in PCS Score at Month 12 Post-Procedure
Time frame: Baseline, Month 12 Post-Procedure
Change from Baseline in PCS Score at Month 18 Post-Procedure
Time frame: Baseline, Month 18 Post-Procedure
Change from Baseline in Sleep Duration at Month 3 Post-Procedure
Time frame: Baseline, Month 3 Post-Procedure
Change from Baseline in Sleep Duration at Month 6 Post-Procedure
Time frame: Baseline, Month 6 Post-Procedure
Change from Baseline in Sleep Duration at Month 12 Post-Procedure
Time frame: Baseline, Month 12 Post-Procedure
Change from Baseline in Sleep Duration at Month 18 Post-Procedure
Time frame: Baseline, Month 18 Post-Procedure

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
Individual participant dataSharing planned: Yes. As an NIH-HEAL initiative sponsored study, our IPD sharing comply with the Helping to End Addiction Long-term (HEAL) Public Access and Data Sharing Policy. The de-identified participant data will be shared and deposited into the National Institute of Mental Health Data Archive (NIMH) Data Archive (NDA). The NDA provides metadata, study digital object identifier (DOI), and long-term access. This repository is supported by several institutes and centers at the NIH, and datasets are available through a request process. Investigators requesting data must be affiliated with an NIH-recognized research institution that maintains an active Federalwide Assurance (FWA), and complete and submit a Data Use Certification approved by an authorized institutional business official with signature authority. This request will then be reviewed by the NDA Data Access Committee.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Lisa Doan, MD contact

212-263-5072

Lisa.doan@nyulangone.org

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Pancreatitis, run by NYU Langone Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lisa Doan, MD (212-263-5072, Lisa.doan@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in Brief Pain Inventory (BPI) Score at Month 3 Post-Operation (time frame: Baseline, Month 3 Post-Operation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06267365.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.