Predictive Biomarker for Endoscopic Therapy in Chronic Pancreatitis

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.

Time frame: 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.

Time frame: 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.

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

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

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

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline, Month 18 Post-Procedure