Chronic PancreatitisP-QSTNCT04996628
Pancreatic Quantitative Sensory Testing (P-QST) to Predict Treatment Response for Pain in Chronic Pancreatitis
A study testing Quantitative Sensory Test 1, Quantitative Sensory Test 2 and Quantitative Sensory Test 3 in people with Chronic Pancreatitis and Chronic Pain, run by University of Pittsburgh at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pancreatitis, Chronic Pain
- What is being tested?
- Quantitative Sensory Test 1, Quantitative Sensory Test 2 and Quantitative Sensory Test 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 3 sitesUnited States
- Study dates
- 4 Jan 2022to 30 Jun 2028
- Phase
- Interventional
- 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
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Apsara Mishra contact
United States3 sites, 3 recruiting
- Recruiting
Johns Hopkins Medical Institutions
Baltimore, Maryland, 21287
Mahya Faghih, MD, 410-614-6708, mfaghih2@jhu.edu
(Site) Vikesh K Singh, MD, MSc
- Recruiting
Indiana University Medical Center
Indianapolis, Indiana, 46202
Suzette Schmidt, RN, 317-278-0691, suschmid@iu.edu
Jeffrey Easler, MD
- Recruiting
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Anna E Phillips, MD, MS, 412-647-2345, evansac3@upmc.edu
Anna E Phillips, MD, MS
About this study
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.
Read the 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.
- Conditions
- Chronic Pancreatitis, Chronic Pain
- Being tested
- Quantitative Sensory Test 1, Quantitative Sensory Test 2, Quantitative Sensory Test 3
- Keywords
- Chronic Pain, Chronic Pancreatitis, Recurrent Acute Pancreatitis, Chronic Abdominal Pain, ERCP, Pancreatic Surgery
- Medical subject headings
- Pancreatitis, Chronic, Chronic Pain, Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantitative Sensory Test 1Diagnostic test
Also called Temporal Summation
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.
Quantitative Sensory Test 2Diagnostic test
Also called Pressure Threshold Testing
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.
Quantitative Sensory Test 3Diagnostic test
Also called Conditioned Pain Modulation
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.
| Study group | Role | What they receive |
|---|---|---|
| Pancreatic Quantitative Sensory Testing (P-QST) | Experimental | 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. Receives: Diagnostic Test: Quantitative Sensory Test 1; Diagnostic Test: Quantitative Sensory Test 2; Diagnostic Test: Quantitative Sensory Test 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.)
Measured: six months post procedure
Secondary outcomes (27)
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)
Measured: 3 months after intervention.
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)
Measured: 6 months after intervention.
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)
Measured: 12 months after intervention.
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)
Measured: at 3 months after intervention
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)
Measured: at 12 months.
Number of patients using prescription opioids for pain control at time of assessment
Opioid use (yes,no binary answer) at 3 months.
Measured: 3 months
Number of patients using prescription opioids for pain control at time of assessment
Opioid use (yes,no) at 6 months.
Measured: 6 months
Number of patients using prescription opioids for pain control at time of assessment
Opioid use (yes,no) at 12 months.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months
Pain relief of ≥30%
Percentage of patients with ≥30% at 3 months after intervention
Measured: 3 months
Pain relief of ≥30%
Percentage of patients with ≥30% at 6 months after intervention
Measured: 6 months
Pain relief of ≥30%
Percentage of patients with ≥30% at 12 months after intervention
Measured: 12 months
Pain relief of ≥50%
Percentage of patients with ≥50% at 3 months after intervention.
Measured: 3 months after intervention
Pain relief of ≥50%
Percentage of patients with ≥50% at 6 months after intervention.
Measured: 6 months after intervention
Pain relief of ≥50%
Percentage of patients with ≥50% at 12 months after intervention.
Measured: 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).
Measured: Baseline, 3, 6, and 12 months
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).
Measured: Baseline, 3, 6, and 12 months
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).
Measured: Baseline, 3, 6, and 12 months
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).
Measured: Baseline, 3, 6, and 12 months
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).
Measured: 3, 6, and 12 months
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).
Measured: Baseline, 3, 6, and 12 months
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).
Measured: Baseline, 3, 6, and 12 months
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).
Measured: Baseline, 3, 6, and 12 months
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.
Measured: Baseline, 3, 6, and 12 months
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).
Measured: Baseline, 3, 6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start4 Jan 2022
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PancreatitisStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Evans Phillips, University of Pittsburgh
- Investigators
- Anna Evans Phillips, MD, MS, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04996628
- Sponsor's protocol ID
- STUDY21050169
- Other IDs
- R01DK127042
- Acronym
- P-QST
- Status last verified
- Sep 2026
- First submitted
- 23 Jul 2021
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Publications
Phillips AE, Afghani E, Akshintala VS, Benos PY, Das R, Drewes AM, Easler J, Faghih M, Gabbert C, Halappa V, Khashab MA, Olesen SS, Saloman JL, Sholosh B, Slivka A, Wang T, Yadav D, Singh VK. Pancreatic quantitative sensory testing to predict treatment response of endoscopic therapy or surgery for painful chronic pancreatitis with pancreatic duct obstruction: study protocol for an observational clinical trial. BMJ Open. 2024 Mar 21;14(3):e081505. doi: 10.1136/bmjopen-2023-081505.
PubMed 38514147
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pancreatic Quantitative Sensory Testing (P-QST) to Predict Treatment Response for Pain in Chronic Pancreatitis
- ClinicalTrials.gov ID
- NCT04996628
- Acronym / sponsor ID
- P-QST / STUDY21050169
- Conditions
- Chronic Pancreatitis, Chronic Pain
- Keywords
- Chronic Pain, Chronic Pancreatitis, Recurrent Acute Pancreatitis, Chronic Abdominal Pain, ERCP, Pancreatic Surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 4 Jan 2022 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 9 Aug 2021 (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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants are assessed at baseline for nociceptive pattern via P-QST and followed longitudinally for the duration of the study
| Arm | Type | Receives |
|---|---|---|
| Pancreatic Quantitative Sensory Testing (P-QST) | Experimental | Diagnostic Test: Quantitative Sensory Test 1, Diagnostic Test: Quantitative Sensory Test 2, Diagnostic Test: Quantitative Sensory Test 3Definite 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quantitative Sensory Test 1Also: Temporal SummationSubject 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. | Diagnostic test | Pancreatic Quantitative Sensory Testing (P-QST) |
| Quantitative Sensory Test 2Also: Pressure Threshold TestingSubject 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. | Diagnostic test | Pancreatic Quantitative Sensory Testing (P-QST) |
| Quantitative Sensory Test 3Also: Conditioned Pain ModulationSubject 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. | Diagnostic test | Pancreatic Quantitative Sensory Testing (P-QST) |
Primary outcome
Average Pain Score
Time frame: six months post procedure
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.)
27 secondary outcomes
Change from baseline in Seven Day Pain Diary Score
Time frame: 3 months after intervention.
Change from baseline in Seven Day Pain Diary Score
Time frame: 6 months after intervention.
Change from baseline in Seven Day Pain Diary Score
Time frame: 12 months after intervention.
Change from baseline in Single-question NRS score
Time frame: at 3 months after intervention
Change from baseline in Single-question NRS score
Time frame: at 12 months.
Number of patients using prescription opioids for pain control at time of assessment
Time frame: 3 months
Number of patients using prescription opioids for pain control at time of assessment
Time frame: 6 months
Number of patients using prescription opioids for pain control at time of assessment
Time frame: 12 months
Mean reported daily opioid dose for patients using prescription opioids at time of assessment
Time frame: 3 months
Mean reported daily opioid dose for patients using prescription opioids at time of assessment
Time frame: 6 months
Mean reported daily opioid dose for patients using prescription opioids at time of assessment
Time frame: 12 months
Pain relief of ≥30%
Time frame: 3 months
Pain relief of ≥30%
Time frame: 6 months
Pain relief of ≥30%
Time frame: 12 months
Pain relief of ≥50%
Time frame: 3 months after intervention
Pain relief of ≥50%
Time frame: 6 months after intervention
Pain relief of ≥50%
Time frame: 12 months after intervention
Change from baseline on the Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Scale
Time frame: Baseline, 3, 6, and 12 months
Change from baseline on the Patient Reported Outcomes Measurement Information System (PROMIS) Neuropathic Pain Scale
Time frame: Baseline, 3, 6, and 12 months
Change from baseline on the Patient Reported Outcomes Measurement Information System (PROMIS) Nociceptive Pain Scale
Time frame: Baseline, 3, 6, and 12 months
Change from baseline on the Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Scale
Time frame: Baseline, 3, 6, and 12 months
Patient Global Impression of Change (PGIC) Scale
Time frame: 3, 6, and 12 months
Change from baseline on the Pain Catastrophizing Scale (PCS)
Time frame: Baseline, 3, 6, and 12 months
Change from baseline on the Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline, 3, 6, and 12 months
Change from baseline on the Modified Brief Pain Inventory Short Form (mBPI-SF)
Time frame: Baseline, 3, 6, and 12 months
Change from baseline on the European Organization for the Research and Treatment of Cancer Quality(EORTC) of Life Questionnaire (QLQ) Core 30 (C30)
Time frame: Baseline, 3, 6, and 12 months
Change from baseline on the Comprehensive Pain Assessment Tool for Pancreatitis Short Form (COMPAT-SF)
Time frame: Baseline, 3, 6, and 12 months
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 11 Sep 2026.
- Derived from this study: PubMed 38514147Phillips AE, Afghani E, Akshintala VS, Benos PY, Das R, Drewes AM, Easler J, Faghih M, Gabbert C, Halappa V, Khashab MA, Olesen SS, Saloman JL, Sholosh B, Slivka A, Wang T, Yadav D, Singh VK. Pancreatic quantitative sensory testing to predict treatment response of endoscopic therapy or surgery for painful chronic pancreatitis with pancreatic duct obstruction: study protocol for an observational clinical trial. BMJ Open. 2024 Mar 21;14(3):e081505. doi: 10.1136/bmjopen-2023-081505.
- Individual participant dataSharing planned: Yes. 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.
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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.
Apsara Mishra contact
Anna Evans Phillips, MD, MS principal investigator
University of Pittsburgh
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quantitative Sensory Test 1, Quantitative Sensory Test 2 and Quantitative Sensory Test 3 in people with Chronic Pancreatitis and Chronic Pain, run by University of Pittsburgh at 3 sites 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 3 inclusion and 8 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 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Anna Evans Phillips, MD, MS (412-647-2345, evansac3@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Pain Score (time frame: six months post procedure). 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 NCT04996628, which also lists 1 linked publication.
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 11 Sep 2026.