Pancreatic Quantitative Sensory Testing for Chronic Pancreatitis Pain

This study is looking at a new way to predict how well treatments will work for pain in people with chronic pancreatitis (CP). It uses special tests called Pancreatic Quantitative Sensory Testing (P-QST) before you have procedures like endoscopic therapy or surgery to relieve blockages in your pancreas. The study wants to see if P-QST can help doctors understand your pain better and predict if these treatments will reduce your pain. You can join if you are an adult (18 or older) with definite CP who is already planning to have endoscopic therapy or surgery for pain. The main goal is to see how your average pain score changes six months after your procedure.

Study design
This is an interventional study planning to enroll 150 participants. It is not specified if it is randomized, blinded, or what phase it is in.
What's involved
You would undergo P-QST testing before your planned endoscopic therapy or surgery. You would then have follow-up visits at 3, 6, and 12 months after your procedure, where you will answer questions about your pain and complete questionnaires. Blood and urine samples will be collected at the start and at 6 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 months after their initial treatment, with the primary pain assessment at six months.

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NCT04996628

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

Recruiting
NAAges 18+InterventionalDiagnostic
University of Pittsburgh
~150 participants
Updated 2025-12-22 on ClinicalTrials.gov
What's tested:Quantitative Sensory Test 1Quantitative Sensory Test 2Quantitative Sensory Test 3

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Average Pain Score
Measured over six months post procedure
Chronic Pancreatitis
Chronic Pain
3 sites across 3 states
Indiana1
Maryland1
Pennsylvania1
  • Anna Evans Phillips, MD, MS · PRINCIPAL_INVESTIGATOR · University of Pittsburgh

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Eligibility criteria

Inclusion

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

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.
  • Average Pain Scoresix 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.)