QST Study: Predicting Treatment Response in Chronic Pancreatitis Using Quantitative Sensory Testing
Chronic Pancreatitis, Chronic Pain
About this trial
This is an interventional diagnostic trial for Chronic Pancreatitis focused on measuring Chronic Pain, Chronic Pancreatitis, Sphincter of Oddi Dysfunction, Recurrent Acute Pancreatitis, Chronic Abdominal Pain, Functional Dyspepsia
Eligibility Criteria
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.
Sites / Locations
- Indiana University Medical CenterRecruiting
- Johns Hopkins Medical InstitutionsRecruiting
- University of Pittsburgh Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Healthy Controls
Suspected CP
Definite CP
Sphincter of Oddi Dysfunction or Functional Dyspepsia
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.
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.
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.
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.