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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Quantitative Sensory Test 1
Diagnostic testSubject 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 testSubject 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 testSubject 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.
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: Pancreatic Quantitative Sensory Testing (P-QST)Experimental treatment 3 interventions
Trial outcomes
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.)
Time frame
six months post procedureSecondary outcomes
1
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)
Time frame
3 months after intervention.2
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)
Time frame
6 months after intervention.3
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)
Time frame
12 months after intervention.4
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)
Time frame
at 3 months after interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Pittsburgh
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov