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P-QST to Predict Pain Treatment Response in Chronic Pancreatitis (P-QST Trial)

N/A

Recruiting

Led By Anna Evans Phillips, MD, MS

Research Sponsored by University of Pittsburgh

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Surgery: drainage procedures (Frey and Puestow operations)

Must not have

Patients who have undergone prior pancreatic surgery

Patients < 18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 3, 6, and 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether a new assessment of neurosensory phenotyping can predict which patients with chronic pancreatitis will respond best to endoscopic therapy or surgery.

Who is the study for?

This trial is for adults over 18 with chronic pancreatitis (CP) experiencing pain, who are scheduled for specific invasive treatments to clear blockages in the pancreatic duct. Eligible patients haven't had endoscopic therapy in the past year and have no other chronic pain conditions or prior pancreatic surgery.

What is being tested?

The study tests Pancreatic Quantitative Sensory Testing (P-QST), a new method to predict if patients with CP will feel less pain after undergoing certain medical procedures like endoscopy or drainage surgeries.

What are the potential side effects?

Since P-QST is a diagnostic procedure rather than a drug, it may cause discomfort during testing. However, there are no direct side effects from P-QST itself as it's used to measure sensory response and predict treatment outcomes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am an adult with chronic pancreatitis, getting treatment to relieve duct blockage.

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I have had surgery to drain my pancreas.

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I have undergone or will undergo a procedure to remove blockages in my pancreas.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had surgery on my pancreas before.

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I am under 18 years old.

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I have chronic pain not caused by chronic pancreatitis.

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I am scheduled for surgery to remove part of my pancreas.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3, 6, and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3, 6, and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3, 6, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Average Pain Score

Secondary study objectives

Pain

Change from baseline in Single-question NRS score

Change from baseline on the Comprehensive Pain Assessment Tool for Pancreatitis Short Form (COMPAT-SF)

+13 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Pancreatic Quantitative Sensory Testing (P-QST)Experimental Treatment3 Interventions

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.

0 / 7Eligibility criteria met