Pancreatic Quantitative Sensory Testing (P-QST) to Predict Treatment Response for Pain in Chronic Pancreatitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Pittsburgh
About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Quantitative Sensory Test 1
- Quantitative Sensory Test 2
- Quantitative Sensory Test 3
Treatment groups
150 Participants
are divided into 1 treatment groupSponsors and collaborators
University of Pittsburgh
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov