NCT03434392 · Anna Evans Phillips
QST Study: Predicting Treatment Response in Chronic Pancreatitis Using Quantitative Sensory Testing
What this study is about
Quantitative Sensory Testing (QST) is a novel investigative technique used in other pain conditions to evaluate patterns of chronic pain, and in this study will be used to elucidate pain patterns in patients with Chronic Pancreatitis (CP). QST uses a specific series of standardized stimulations to map the pain system.
View original scientific description
Quantitative Sensory Testing (QST) is a novel investigative technique used in other pain conditions to evaluate patterns of chronic pain, and in this study will be used to elucidate pain patterns in patients with Chronic Pancreatitis (CP). QST uses a specific series of standardized stimulations to map the pain system. QST has the potential to change and improve the treatment paradigm for patients with CP and may eventually be able to predict response to invasive CP therapies.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Subjects with no pancreatic disease and no abdominal pain, or patients with a diagnosis of functional dyspepsia.
- Subjects are 18 years or older in age
- Subjects must be able to read and understand the study information.
- Personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
- Subject is willing and able to comply with the scheduled visits, questionnaires, treatment plan, and other study procedures.
- Suspected CPs Inclusion Criteria
- Subjects are 18 years or older in age
- Subjects with a) Indeterminate CP (Cambridge 1 or 2 on CT scan or MRI/MRCP) who have abdominal pain without prior history of AP, or b) those with acute (AP) or recurrent acute pancreatitis (RAP) who have recovered from their attack(s) of AP, whose imaging studies are either normal or show changes consistent with Cambridge classification of 1 or 2, and they have ongoing abdominal pain. Both diabetic and non-diabetic subjects will be allowed to enter the study.
- Subjects must be able to read and understand the study information.
- 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).
- Personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
- Subjects willing and able to comply with the scheduled visits, questionnaires, and other study procedures.
- Definite Chronic Pancreatitis - Inclusion Criteria
- Subjects are 18 years or older in age
- Subjects will have a prior confirmed diagnosis of CP on CT scan or MRI/MRCP according to Cambridge Classification (grade 3 or 4). Both diabetic and non-diabetic subjects will be allowed to enter the study.
- Subjects must be able to read and understand the study information.
- Personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
- Subjects willing and able to comply with the scheduled visits, questionnaires, and other study procedures.
- Sphincter of Oddi Dysfunction (SOD) Type 1 or Type 2 Inclusion Criteria
- Subjects are 18 years or older in age
- 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)
- Subjects must be able to read and understand the study information.
- Personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
- Subjects willing and able to comply with the scheduled visits, questionnaires, and other study procedures.
Exclusion criteria
- Subjects with no pancreatic disease and no abdominal pain, or patients with a diagnosis of functional dyspepsia.
- Subjects with evidence or history of medical or surgical disease of importance for this study as judged by investigator.
- Subjects suffering from painful conditions that make them unable to distinguish the pain associated with CP from chronic pain of other origins.
- Subjects with known pregnancy at the time of enrolment.
- Subjects who have previously undergone surgical intervention on their pancreas.
- Suspected CPs Exclusion Criteria
- Subjects with evidence or history of medical or surgical disease of importance for this study as judged by investigator.
- Subjects suffering from painful conditions other than pancreatitis or SOD type 1 or 2 that make them unable to distinguish the pain associated with pancreatitis or SOD from chronic pain of other origins.
- Subjects with known pregnancy at the time of enrolment.
- Subjects who have previously undergone surgical intervention on their pancreas.
- Definite Chronic Pancreatitis Exclusion Criteria
- Subjects with evidence or history of medical or surgical disease of importance for this study as judged by investigator.
- Subjects suffering from painful conditions other than pancreatitis or SOD type 1 or 2 that make them unable to distinguish the pain associated with pancreatitis or SOD from chronic pain of other origins.
- Subjects with known pregnancy at the time of enrolment.
- Subjects who have previously undergone surgical intervention on their pancreas.
- Sphincter of Oddi Dysfunction (SOD) Type 1 or Type 2 Exclusion Criteria
- Subjects with evidence or history of medical or surgical disease of importance for this study as judged by investigator.
- Subjects suffering from painful conditions other than pancreatitis or SOD that make them unable to distinguish the pain associated with pancreatitis or SOD from chronic pain of other origins.
- Subjects with known pregnancy at the time of enrolment.
- Subjects who have previously undergone surgical intervention on their pancreas.
Where
- Baltimore, Maryland
- Pittsburgh, Pennsylvania
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 18, 2025 · Source of record for eligibility and locations