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

University of Pittsburgh

Status: Enrolling

Conditions: Chronic Pancreatitis; Chronic Pain

Treatments: Diagnostic Test: Quantitative Sensory Test 3; Diagnostic Test: Quantitative Sensory Test 1; Diagnostic Test: Quantitative Sensory Test 2

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04996628

R01DK127042 (U.S. NIH Grant/Contract)

STUDY21050169

Details and patient eligibility

About

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.

Full description

P-QST has been shown to be able to phenotype patients with CP into nociceptive patterns according to degree of central sensitization. As a tool to identify baseline nociceptive pattern in patients with painful CP, P-QST will be performed at baseline prior to planned invasive treatment with endoscopic therapy or decompressive surgery. We will evaluate the ability of P-QST to predict response to invasive treatment for painful CP, and to develop a predictive model for individualized prediction of treatment response.

Patients will undergo pre-procedure P-QST testing before undergoing scheduled invasive treatment as directed by their treating gastroenterologist. The date of first endoscopic therapy or surgery will be used to calculate follow-up timepoints, which will be scheduled at 3, 6, and 12 months after the first endotherapy session or surgery. At each follow-up time point, patients will answer questions about their pain. In addition, patients will complete patient reported outcome tools (HADS, PCS instruments) and the Patient Global Impression of Change. Serum and urine samples will be obtained at baseline and at 6-month follow-up timepoints.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

Pancreatic Quantitative Sensory Testing (P-QST)

Experimental group

Description:

Definite 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.

Treatment:

Diagnostic Test: Quantitative Sensory Test 2

Diagnostic Test: Quantitative Sensory Test 1

Diagnostic Test: Quantitative Sensory Test 3