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RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: University of Pittsburgh • ClinicalTrials.gov ID: NCT04996628

Registry updated: 2026-09-11
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Description

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.

Interventions

  • Quantitative Sensory Test 1 (Diagnostic test)
    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 2 (Diagnostic test)
    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 3 (Diagnostic test)
    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

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.

Conditions

Chronic Pancreatitis Chronic Pain

Locations

  • Indiana University Medical Center — Indianapolis, Indiana, United States
  • Johns Hopkins Medical Institutions — Baltimore, Maryland, United States
  • University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record