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Pancreatic Quantitative Sensory Testing (P-QST) to Predict Treatment Response for Pain in Chronic Pancreatitis (P-QST)

Primary Purpose

Chronic Pancreatitis, Chronic Pain

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Quantitative Sensory Test 1
Quantitative Sensory Test 2
Quantitative Sensory Test 3
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chronic Pancreatitis focused on measuring Chronic Pain, Chronic Pancreatitis, Recurrent Acute Pancreatitis, Chronic Abdominal Pain, ERCP, Pancreatic Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult patients ≥ 18 years of age with definite CP undergoing decompressive invasive treatments (endoscopic therapy or surgery) to relieve main pancreatic duct obstruction due to stones and/or stricture for management of pain.

    • Endoscopic therapy: Endoscopic Retrograde Cholangiopancreatography (ERCP) with pancreatic duct stone removal, stent placement, and/or stricture dilation, ± intraductal lithotripsy or Extracorporeal Shock Wave Lithotripsy (ESWL).
    • Surgery: drainage procedures (Frey and Puestow operations)

Exclusion Criteria:

  • Patients with chronic pain from conditions other than CP
  • Patients < 18 years of age
  • Patients who have had endoscopic therapy within the past 12 months
  • Patients who have undergone prior pancreatic surgery
  • Patients who have resective surgical procedure planned (eg. Whipple procedure, Total Pancreatectomy)
  • Patients with peripheral sensory deficits

  • Patients with known pregnancy at the time of study screening**

    • Note: Women who become pregnant during the course of the study can no longer participate in P-QST testing.

Sites / Locations

  • Indiana University Medical CenterRecruiting
  • Johns Hopkins Medical InstitutionsRecruiting
  • University of Pittsburgh Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pancreatic Quantitative Sensory Testing (P-QST)

Arm Description

Definite Chronic Pancreatitis patients undergoing decompressive invasive treatments (endoscopic therapy or surgery) to relieve main pancreatic duct obstruction due to stones and/or stricture for management of pain will undergo P-QST prior to clinically-indicated invasive treatment.

Outcomes

Primary Outcome Measures

Average Pain Score
The primary outcome of the study is average pain score at 6 months post-procedure based on single-question numeric rating scale (NRS) (Scale of 0 to 10 how intense abdominal pain has been on average over the past 7 days (Scale: 0=No pain, 10=Worst pain Imaginable.)

Secondary Outcome Measures

Change from baseline in Seven Day Pain Diary Score
The 7-day pain diary average score at 3 months after intervention. (Scale 0 = no pain to 10 = worst pain imaginable)
Change from baseline in Seven Day Pain Diary Score
The 7-day pain diary average score at 6 months after intervention. (Scale 0 = no pain to 10 = worst pain imaginable)
Change from baseline in Seven Day Pain Diary Score
The 7-day pain diary average score at 12 months after intervention. (Scale 0 = no pain to 10 = worst pain imaginable)
Change from baseline in Single-question NRS score
Single-question NRS at 3 months after intervention (Scale 0 = no pain to 10 = worst pain imaginable)
Change from baseline in Single-question NRS score
Single-question NRS at 12 months after intervention (Scale 0 = no pain to 10 = worst pain imaginable)
Number of patients using prescription opioids for pain control at time of assessment
Opioid use (yes,no binary answer) at 3 months.
Number of patients using prescription opioids for pain control at time of assessment
Opioid use (yes,no) at 6 months.
Number of patients using prescription opioids for pain control at time of assessment
Opioid use (yes,no) at 12 months.
Mean reported daily opioid dose for patients using prescription opioids at time of assessment
Opioid dose (continuous variable in milligrams of morphine equivalent) at 3 months.
Mean reported daily opioid dose for patients using prescription opioids at time of assessment
Opioid dose (continuous variable in milligrams of morphine equivalent) at 6 months.
Mean reported daily opioid dose for patients using prescription opioids at time of assessment
Opioid dose (continuous variable in milligrams of morphine equivalent) at 12 months.
Pain relief of ≥30%
Percentage of patients with ≥30% at 3 months after intervention
Pain relief of ≥30%
Percentage of patients with ≥30% at 6 months after intervention
Pain relief of ≥30%
Percentage of patients with ≥30% at 12 months after intervention
Pain relief of ≥50%
Percentage of patients with ≥50% at 3 months after intervention.
Pain relief of ≥50%
Percentage of patients with ≥50% at 6 months after intervention.
Pain relief of ≥50%
Percentage of patients with ≥50% at 12 months after intervention.
Change from baseline on the Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Scale
The PROMIS Global Health Questionnaire is a validated self-reported tool that scores both mental and physical health at the time of assessment. Possible scores for both Mental and Physical Health range from 7 to 35 (lower score corresponds to poorer physical or mental health).
Change from baseline on the Patient Reported Outcomes Measurement Information System (PROMIS) Neuropathic Pain Scale
The PROMIS Global Health Questionnaire is a validated self-reported tool that scores neuropathic pain characteristics at the time of assessment. Possible scores range from 5 to 25 (higher score corresponds to more neuropathic pain characteristics).
Change from baseline on the Patient Reported Outcomes Measurement Information System (PROMIS) Nociceptive Pain Scale
The PROMIS Global Health Questionnaire is a validated self-reported tool that scores nociceptive pain characteristics at the time of assessment. Possible scores range from 5 to 25 (higher score corresponds to more nociceptive pain characteristics).
Change from baseline on the Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Scale
The PROMIS Global Health Questionnaire is a validated self-reported tool that scores pain interference with aspects of daily life at the time of assessment. Possible scores range from 6 to 30 (higher score corresponds to more pain interference with daily activities).
Patient Global Impression of Change (PGIC) Scale
The PGIC is a validated self-reported tool that scores the patient's impression of change from baseline of their pain and overall health. Possible scores range from 1 to 7 (higher score corresponds to improvement).
Change from baseline on the Pain Catastrophizing Scale (PCS)
The PCS is a validated self-reported tool that scores the patient tendency to catastrophize about pain or potential pain. Possible scores range from 0 to 42 (higher scores reflect more catastrophizing tendencies).
Change from baseline on the Hospital Anxiety and Depression Scale (HADS)
The HADS is a validated self-reported tool that screens for symptoms of anxiety and depression. Possible scores range from 0 to 21 (higher scores reflect more severe symptoms of anxiety or depression).
Change from baseline on the Modified Brief Pain Inventory Short Form (mBPI-SF)
The mBPI-SF is a validated self-reported tool that evaluates pain severity and pain interference with daily activities at the time of assessment. Possible scores for pain severity range from 0 to 40 (higher scores reflect more severe pain); possible scores for pain interference range from 0 to 70 (higher scores reflect more pain interference with daily life).
Change from baseline on the European Organization for the Research and Treatment of Cancer Quality(EORTC) of Life Questionnaire (QLQ) Core 30 (C30)
The EORTC QLQ-C30 is a validated self-reported tool measuring quality of life that reports scores on global health (quality of life), functioning (physical, role, emotional, cognitive, social), and symptoms (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). All scores range from 0 to 100. A high score on quality of life indicates higher quality of life; a high score on a functioning scale indicates a higher level of functioning, and a high score on a symptom scale indicates a higher level of symptoms.
Change from baseline on the Comprehensive Pain Assessment Tool for Pancreatitis Short Form (COMPAT-SF)
The COMPAT-SF is a validated self-reported tool specifically designed for patients with pancreatic disease. Scores for pain severity (average, worst, and least) range from 0 to 10 (higher corresponds to more pain); scores for pain triggers (including food, exercise, and thermal changes) are scored on a scale from never to always (never, rarely, sometimes, very often, always); scores for pain symptom characteristics (cramping, shooting, stabbing) are scored on a scale from 0 (none) to 10 (worst possible).

Full Information

First Posted
July 23, 2021
Last Updated
July 20, 2023
Sponsor
University of Pittsburgh
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT04996628
Brief Title
Pancreatic Quantitative Sensory Testing (P-QST) to Predict Treatment Response for Pain in Chronic Pancreatitis
Acronym
P-QST
Official Title
Pancreatic Quantitative Sensory Testing (P-QST) to Predict Treatment Response for Pain in Chronic Pancreatitis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 4, 2022 (Actual)
Primary Completion Date
June 30, 2026 (Anticipated)
Study Completion Date
June 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Abdominal pain in chronic pancreatitis (CP) affects up to 90% of patients during the course of their disease, and response to currently available therapies is suboptimal and unpredictable. The proposed clinical trial will evaluate the predictive capability of Pancreatic Quantitative Sensory Testing (P-QST) - a novel assessment of neurosensory phenotyping- for improvement in pain in patients with CP who are undergoing medically-indicated invasive treatment with endoscopic therapy or surgery.
Detailed Description
P-QST has been shown to be able to phenotype patients with CP into nociceptive patterns according to degree of central sensitization. As a tool to identify baseline nociceptive pattern in patients with painful CP, P-QST will be performed at baseline prior to planned invasive treatment with endoscopic therapy or decompressive surgery. We will evaluate the ability of P-QST to predict response to invasive treatment for painful CP, and to develop a predictive model for individualized prediction of treatment response. Patients will undergo pre-procedure P-QST testing before undergoing scheduled invasive treatment as directed by their treating gastroenterologist. The date of first endoscopic therapy or surgery will be used to calculate follow-up timepoints, which will be scheduled at 3, 6, and 12 months after the first endotherapy session or surgery. At each follow-up time point, patients will answer questions about their pain. In addition, patients will complete patient reported outcome tools (HADS, PCS instruments) and the Patient Global Impression of Change. Serum and urine samples will be obtained at baseline and at 6-month follow-up timepoints.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pancreatitis, Chronic Pain
Keywords
Chronic Pain, Chronic Pancreatitis, Recurrent Acute Pancreatitis, Chronic Abdominal Pain, ERCP, Pancreatic Surgery

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Participants are assessed at baseline for nociceptive pattern via P-QST and followed longitudinally for the duration of the study
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pancreatic Quantitative Sensory Testing (P-QST)
Arm Type
Experimental
Arm Description
Definite Chronic Pancreatitis patients undergoing decompressive invasive treatments (endoscopic therapy or surgery) to relieve main pancreatic duct obstruction due to stones and/or stricture for management of pain will undergo P-QST prior to clinically-indicated invasive treatment.
Intervention Type
Diagnostic Test
Intervention Name(s)
Quantitative Sensory Test 1
Other Intervention Name(s)
Temporal Summation
Intervention Description
Subject will give pain rating (on Visual Analogue Scale (VAS) 0-10) of single as well as multiple stimulation with round-tip non-invasive pin-prick device. Difference is recorded as Temporal Summation Score.
Intervention Type
Diagnostic Test
Intervention Name(s)
Quantitative Sensory Test 2
Other Intervention Name(s)
Pressure Threshold Testing
Intervention Description
Subject will state when they first detect pain and pain detection threshold in response to pressure administration with pressure algometer. Pressure threshold recorded in kilopascals(kP). Stimulation will be repeated in pancreatic and control dermatomes. Subject will then state pain tolerance threshold at same locations. Sensitization will be characterized by ratio of pancreatic vs. control dermatome scores.
Intervention Type
Diagnostic Test
Intervention Name(s)
Quantitative Sensory Test 3
Other Intervention Name(s)
Conditioned Pain Modulation
Intervention Description
Subject will apply dominant hand to ice-chilled water bath (36F) for up to 2 minutes. Pain score (VAS 0-10) will be assessed each 10 seconds. Pain tolerance threshold (in kP) will be assessed with algometer on non-dominant thigh before and after water bath to determine change in threshold. Difference in pain tolerance recorded as Conditioned Pain Modulation Score.
Primary Outcome Measure Information:
Title
Average Pain Score
Description
The primary outcome of the study is average pain score at 6 months post-procedure based on single-question numeric rating scale (NRS) (Scale of 0 to 10 how intense abdominal pain has been on average over the past 7 days (Scale: 0=No pain, 10=Worst pain Imaginable.)
Time Frame
six months post procedure
Secondary Outcome Measure Information:
Title
Change from baseline in Seven Day Pain Diary Score
Description
The 7-day pain diary average score at 3 months after intervention. (Scale 0 = no pain to 10 = worst pain imaginable)
Time Frame
3 months after intervention.
Title
Change from baseline in Seven Day Pain Diary Score
Description
The 7-day pain diary average score at 6 months after intervention. (Scale 0 = no pain to 10 = worst pain imaginable)
Time Frame
6 months after intervention.
Title
Change from baseline in Seven Day Pain Diary Score
Description
The 7-day pain diary average score at 12 months after intervention. (Scale 0 = no pain to 10 = worst pain imaginable)
Time Frame
12 months after intervention.
Title
Change from baseline in Single-question NRS score
Description
Single-question NRS at 3 months after intervention (Scale 0 = no pain to 10 = worst pain imaginable)
Time Frame
at 3 months after intervention
Title
Change from baseline in Single-question NRS score
Description
Single-question NRS at 12 months after intervention (Scale 0 = no pain to 10 = worst pain imaginable)
Time Frame
at 12 months.
Title
Number of patients using prescription opioids for pain control at time of assessment
Description
Opioid use (yes,no binary answer) at 3 months.
Time Frame
3 months
Title
Number of patients using prescription opioids for pain control at time of assessment
Description
Opioid use (yes,no) at 6 months.
Time Frame
6 months
Title
Number of patients using prescription opioids for pain control at time of assessment
Description
Opioid use (yes,no) at 12 months.
Time Frame
12 months
Title
Mean reported daily opioid dose for patients using prescription opioids at time of assessment
Description
Opioid dose (continuous variable in milligrams of morphine equivalent) at 3 months.
Time Frame
3 months
Title
Mean reported daily opioid dose for patients using prescription opioids at time of assessment
Description
Opioid dose (continuous variable in milligrams of morphine equivalent) at 6 months.
Time Frame
6 months
Title
Mean reported daily opioid dose for patients using prescription opioids at time of assessment
Description
Opioid dose (continuous variable in milligrams of morphine equivalent) at 12 months.
Time Frame
12 months
Title
Pain relief of ≥30%
Description
Percentage of patients with ≥30% at 3 months after intervention
Time Frame
3 months
Title
Pain relief of ≥30%
Description
Percentage of patients with ≥30% at 6 months after intervention
Time Frame
6 months
Title
Pain relief of ≥30%
Description
Percentage of patients with ≥30% at 12 months after intervention
Time Frame
12 months
Title
Pain relief of ≥50%
Description
Percentage of patients with ≥50% at 3 months after intervention.
Time Frame
3 months after intervention
Title
Pain relief of ≥50%
Description
Percentage of patients with ≥50% at 6 months after intervention.
Time Frame
6 months after intervention
Title
Pain relief of ≥50%
Description
Percentage of patients with ≥50% at 12 months after intervention.
Time Frame
12 months after intervention
Title
Change from baseline on the Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Scale
Description
The PROMIS Global Health Questionnaire is a validated self-reported tool that scores both mental and physical health at the time of assessment. Possible scores for both Mental and Physical Health range from 7 to 35 (lower score corresponds to poorer physical or mental health).
Time Frame
Baseline, 3, 6, and 12 months
Title
Change from baseline on the Patient Reported Outcomes Measurement Information System (PROMIS) Neuropathic Pain Scale
Description
The PROMIS Global Health Questionnaire is a validated self-reported tool that scores neuropathic pain characteristics at the time of assessment. Possible scores range from 5 to 25 (higher score corresponds to more neuropathic pain characteristics).
Time Frame
Baseline, 3, 6, and 12 months
Title
Change from baseline on the Patient Reported Outcomes Measurement Information System (PROMIS) Nociceptive Pain Scale
Description
The PROMIS Global Health Questionnaire is a validated self-reported tool that scores nociceptive pain characteristics at the time of assessment. Possible scores range from 5 to 25 (higher score corresponds to more nociceptive pain characteristics).
Time Frame
Baseline, 3, 6, and 12 months
Title
Change from baseline on the Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Scale
Description
The PROMIS Global Health Questionnaire is a validated self-reported tool that scores pain interference with aspects of daily life at the time of assessment. Possible scores range from 6 to 30 (higher score corresponds to more pain interference with daily activities).
Time Frame
Baseline, 3, 6, and 12 months
Title
Patient Global Impression of Change (PGIC) Scale
Description
The PGIC is a validated self-reported tool that scores the patient's impression of change from baseline of their pain and overall health. Possible scores range from 1 to 7 (higher score corresponds to improvement).
Time Frame
3, 6, and 12 months
Title
Change from baseline on the Pain Catastrophizing Scale (PCS)
Description
The PCS is a validated self-reported tool that scores the patient tendency to catastrophize about pain or potential pain. Possible scores range from 0 to 42 (higher scores reflect more catastrophizing tendencies).
Time Frame
Baseline, 3, 6, and 12 months
Title
Change from baseline on the Hospital Anxiety and Depression Scale (HADS)
Description
The HADS is a validated self-reported tool that screens for symptoms of anxiety and depression. Possible scores range from 0 to 21 (higher scores reflect more severe symptoms of anxiety or depression).
Time Frame
Baseline, 3, 6, and 12 months
Title
Change from baseline on the Modified Brief Pain Inventory Short Form (mBPI-SF)
Description
The mBPI-SF is a validated self-reported tool that evaluates pain severity and pain interference with daily activities at the time of assessment. Possible scores for pain severity range from 0 to 40 (higher scores reflect more severe pain); possible scores for pain interference range from 0 to 70 (higher scores reflect more pain interference with daily life).
Time Frame
Baseline, 3, 6, and 12 months
Title
Change from baseline on the European Organization for the Research and Treatment of Cancer Quality(EORTC) of Life Questionnaire (QLQ) Core 30 (C30)
Description
The EORTC QLQ-C30 is a validated self-reported tool measuring quality of life that reports scores on global health (quality of life), functioning (physical, role, emotional, cognitive, social), and symptoms (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). All scores range from 0 to 100. A high score on quality of life indicates higher quality of life; a high score on a functioning scale indicates a higher level of functioning, and a high score on a symptom scale indicates a higher level of symptoms.
Time Frame
Baseline, 3, 6, and 12 months
Title
Change from baseline on the Comprehensive Pain Assessment Tool for Pancreatitis Short Form (COMPAT-SF)
Description
The COMPAT-SF is a validated self-reported tool specifically designed for patients with pancreatic disease. Scores for pain severity (average, worst, and least) range from 0 to 10 (higher corresponds to more pain); scores for pain triggers (including food, exercise, and thermal changes) are scored on a scale from never to always (never, rarely, sometimes, very often, always); scores for pain symptom characteristics (cramping, shooting, stabbing) are scored on a scale from 0 (none) to 10 (worst possible).
Time Frame
Baseline, 3, 6, and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients ≥ 18 years of age with definite CP undergoing decompressive invasive treatments (endoscopic therapy or surgery) to relieve main pancreatic duct obstruction due to stones and/or stricture for management of pain. Endoscopic therapy: Endoscopic Retrograde Cholangiopancreatography (ERCP) with pancreatic duct stone removal, stent placement, and/or stricture dilation, ± intraductal lithotripsy or Extracorporeal Shock Wave Lithotripsy (ESWL). Surgery: drainage procedures (Frey and Puestow operations) Exclusion Criteria: Patients with chronic pain from conditions other than CP Patients < 18 years of age Patients who have had endoscopic therapy within the past 12 months Patients who have undergone prior pancreatic surgery Patients who have resective surgical procedure planned (eg. Whipple procedure, Total Pancreatectomy) Patients with peripheral sensory deficits Patients with known pregnancy at the time of study screening** Note: Women who become pregnant during the course of the study can no longer participate in P-QST testing.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anna Evans Phillips, MD, MS
Phone
412-647-2345
Email
evansac3@upmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Evans Phillips, MD, MS
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University Medical Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suzette Schmidt, RN
Phone
317-278-0691
Email
suschmid@iu.edu
First Name & Middle Initial & Last Name & Degree
Jeffrey Easler, MD
Facility Name
Johns Hopkins Medical Institutions
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mahya Faghih, MD
Phone
410-614-6708
Email
mfaghih2@jhu.edu
First Name & Middle Initial & Last Name & Degree
(Site) Vikesh K Singh, MD, MSc
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna E Phillips, MD, MS
Phone
412-647-2345
Email
evansac3@upmc.edu
First Name & Middle Initial & Last Name & Degree
Anna E Phillips, MD, MS

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified patient data may be shared with investigators from outside institutions for ancillary studies upon request. Requests should be made to study principal investigator at evansac3@upmc.edu. Researchers interested in learning techniques of P-QST will be able to receive information and training upon request through our institutions. Results and conclusions from this project will be shared publicly with other medical research and physicians through presentation at scientific meetings and in one or more final publications.
IPD Sharing Time Frame
Data will be available at the close of the study and for 5 years subsequent.
IPD Sharing Access Criteria
Individual requests for data sharing can be made to evansac3@upmc.edu

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Pancreatic Quantitative Sensory Testing (P-QST) to Predict Treatment Response for Pain in Chronic Pancreatitis

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