Pancreatic Quantitative Sensory Testing (P-QST) to Predict Treatment Response for Pain in Chronic Pancreatitis
P-QST
2 other identifiers
interventional
150
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2022
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 23, 2021
CompletedFirst Posted
Study publicly available on registry
August 9, 2021
CompletedStudy Start
First participant enrolled
January 4, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
December 22, 2025
December 1, 2025
4.5 years
July 23, 2021
December 19, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.)
six months post procedure
Secondary Outcomes (27)
Change from baseline in Seven Day Pain Diary Score
3 months after intervention.
Change from baseline in Seven Day Pain Diary Score
6 months after intervention.
Change from baseline in Seven Day Pain Diary Score
12 months after intervention.
Change from baseline in Single-question NRS score
at 3 months after intervention
Change from baseline in Single-question NRS score
at 12 months.
- +22 more secondary outcomes
Study Arms (1)
Pancreatic Quantitative Sensory Testing (P-QST)
EXPERIMENTALDefinite 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.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Indiana University Medical Center
Indianapolis, Indiana, 46202, United States
Johns Hopkins Medical Institutions
Baltimore, Maryland, 21287, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Related Publications (1)
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.
PMID: 38514147DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anna Evans Phillips, MD, MS
University of Pittsburgh
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 23, 2021
First Posted
August 9, 2021
Study Start
January 4, 2022
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
December 22, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Data will be available at the close of the study and for 5 years subsequent.
- Access Criteria
- Individual requests for data sharing can be made to evansac3@upmc.edu
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.