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QST for Chronic Pancreatitis

N/A

Recruiting

Led By Anna Evans-Phillips, MD

Research Sponsored by Anna Evans Phillips

Eligibility Criteria Checklist

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

Must have

Subjects must suffer from abdominal pain suspected to be pancreatic origin with an intensity above 3 on the visual analogue scale (VAS, where 0=no pain and 10= intolerable pain), and meet the criteria for chronic pain (pain ≥ 3 days per week for at least 3 months).

Subjects have prior diagnosis of Type 1 or Type 2 Sphincter of Oddi Dysfunction (subjects with biliary pain accompanied by biochemical features of transient biliary tract obstruction including elevated transaminases, alkaline phosphatase, or conjugated bilirubin; may also be accompanied by biliary or pancreatic ductal dilation on imaging)

Must not have

Subjects who have previously undergone surgical intervention on their pancreas.

Subjects suffering from painful conditions that make them unable to distinguish the pain associated with CP from chronic pain of other origins.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90 days

Awards & highlights

No Placebo-Only Group

Summary

This trial will use a new technique, quantitative sensory testing (QST), to map pain patterns in people with chronic pancreatitis (CP). QST has the potential to improve treatment for CP and may eventually be able to predict response to CP therapies.

Who is the study for?

This trial is for adults with chronic pancreatitis who experience abdominal pain of pancreatic origin, rated above 3 on the pain scale. They must have had this pain frequently over the last three months and may have a history of surgical intervention on their pancreas. Pregnant individuals or those unable to distinguish their pancreatic pain from other types are excluded.

What is being tested?

The study tests Quantitative Sensory Testing (QST), which uses standardized stimulations to map out patterns of chronic pain in patients with Chronic Pancreatitis. The goal is to improve treatment strategies and potentially predict responses to invasive therapies.

What are the potential side effects?

As QST involves sensory testing rather than medication or surgery, it's not expected to cause typical side effects. However, participants might experience discomfort during the testing process due to the nature of sensory stimulation.

Eligibility Criteria

Inclusion Criteria

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

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I have chronic abdominal pain suspected to be from the pancreas, rated above 3 on a scale of 0-10.

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I have been diagnosed with a type of Sphincter of Oddi Dysfunction.

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I either have no pancreatic disease and no abdominal pain, or I have been diagnosed with functional dyspepsia.

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I am 18 years old or older.

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I can tell my pancreatitis pain apart from other chronic pains.

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 can't tell my chronic pain apart from other types of pain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one-time baseline testing

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one-time baseline testing

This trial's timeline: 3 weeks for screening, Varies for treatment, and one-time baseline testing for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Pain Pattern Assessment as assessed by the combination of Temporal Summation score, Sensitization score, and Conditioned Pain Modulation score

Secondary study objectives

Change in Mean Pain score

Awards & Highlights

No Placebo-Only Group

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

Trial Design

4Treatment groups

Active Control

Group I: Sphincter of Oddi Dysfunction or Functional DyspepsiaActive Control3 Interventions

Patients with Sphincter of Oddi Dysfunction Type 1 or Type 2, or who have a prior diagnosis of Functional Dyspepsia. Subjects will undergo the following Interventions: Quantitative Sensory Test 1, Quantitative Sensory Test 2, and Quantitative Sensory Test 3, They will also fill out validated questionnaires.

Group II: Healthy ControlsActive Control3 Interventions

Subjects with no pancreatic disease and no abdominal pain. Subjects will undergo the following Interventions: Quantitative Sensory Test 1, Quantitative Sensory Test 2, and Quantitative Sensory Test 3, They will also fill out validated questionnaires.

Group III: Suspected CPActive Control3 Interventions

Suspected Chronic Pancreatitis patients. Subjects will undergo the following Interventions: Quantitative Sensory Test 1, Quantitative Sensory Test 2, and Quantitative Sensory Test 3, They will also fill out validated questionnaires.

Group IV: Definite CPActive Control3 Interventions

Definite Chronic Pancreatitis patients. Subjects will undergo the following Interventions: Quantitative Sensory Test 1, Quantitative Sensory Test 2, and Quantitative Sensory Test 3, They will also fill out validated questionnaires. A subset of these patients who undergo endotherapy as per clinical recommendation from clinical provider independent of this study will be followed for 6 months after their clinical intervention for repeat Quantitative Sensory Test 1, Quantitative Sensory Test 2, and Quantitative Sensory Test 3 and questionnaires.

0 / 7Eligibility criteria met