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

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Brief Title

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

Official Title

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

Brief Summary

      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.
    

Detailed 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.
    


Study Type

Interventional


Primary Outcome

Average Pain Score

Secondary Outcome

 Change from baseline in Seven Day Pain Diary Score

Condition

Chronic Pancreatitis

Intervention

Quantitative Sensory Test 1

Study Arms / Comparison Groups

 Pancreatic Quantitative Sensory Testing (P-QST)
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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Diagnostic Test

Estimated Enrollment

150

Start Date

January 4, 2022

Completion Date

June 30, 2026

Primary Completion Date

June 30, 2026

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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Anna Evans Phillips, MD, MS, 412-647-2345, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04996628

Organization ID

STUDY21050169

Secondary IDs

R01DK127042

Responsible Party

Principal Investigator

Study Sponsor

University of Pittsburgh

Collaborators

 National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Sponsor

Anna Evans Phillips, MD, MS, Principal Investigator, University of Pittsburgh


Verification Date

January 2022