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New treatment option for Chronic Pancreatitis
Official title QST Study: Predicting Treatment Response in Chronic Pancreatitis Using Quantitative Sensory Testing
ClinicalTrials.gov ID: NCT03434392
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- people with no pancreatic disease and no abdominal pain, or patients with a diagnosis of functional dyspepsia.
- people are 18 years or older in age
- people 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.
You likely can't join if
- people with no pancreatic disease and no abdominal pain, or patients with a diagnosis of functional dyspepsia.
- people with evidence or history of medical or surgical disease of importance for this study as judged by investigator.
- people suffering from painful conditions that make them unable to distinguish the pain associated with CP from chronic pain of other origins.
- people with known pregnancy at the time of enrolment.
- people who have previously undergone surgical intervention on their pancreas.
- Suspected CPs Exclusion Criteria
See the full eligibility criteria
Who can join
- people with no pancreatic disease and no abdominal pain, or patients with a diagnosis of functional dyspepsia.
- people are 18 years or older in age
- people 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 people are 18 years or older in age
- people 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...
- people must be able to read and understand the study information.
- people 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...
- Personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
- people willing and able to comply with the scheduled visits, questionnaires, and other study procedures.
- Definite Chronic Pancreatitis - people are 18 years or older in age
- people 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 people will be allowed to enter the study.
- people 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.
- people willing and able to comply with the scheduled visits, questionnaires, and other study procedures.
- Sphincter of Oddi Dysfunction (SOD) Type 1 or Type 2 people are 18 years or older in age
- people have prior diagnosis of Type 1 or Type 2 Sphincter of Oddi Dysfunction (people with biliary pain accompanied by biochemical features of transient biliary tract obstruction including elevated transaminases...
- people 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.
- people willing and able to comply with the scheduled visits, questionnaires, and other study procedures.
What rules you out
- people with no pancreatic disease and no abdominal pain, or patients with a diagnosis of functional dyspepsia.
- people with evidence or history of medical or surgical disease of importance for this study as judged by investigator.
- people suffering from painful conditions that make them unable to distinguish the pain associated with CP from chronic pain of other origins.
- people with known pregnancy at the time of enrolment.
- people who have previously undergone surgical intervention on their pancreas.
- Suspected CPs Exclusion Criteria
- people with evidence or history of medical or surgical disease of importance for this study as judged by investigator.
- people 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.
- people with known pregnancy at the time of enrolment.
- people who have previously undergone surgical intervention on their pancreas.
- Definite Chronic Pancreatitis Exclusion Criteria
- people with evidence or history of medical or surgical disease of importance for this study as judged by investigator.
- people 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.
- people with known pregnancy at the time of enrolment.
- people who have previously undergone surgical intervention on their pancreas.
- Sphincter of Oddi Dysfunction (SOD) Type 1 or Type 2 Exclusion Criteria
- people with evidence or history of medical or surgical disease of importance for this study as judged by investigator.
- people 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.
- people with known pregnancy at the time of enrolment.
- people who have previously undergone surgical intervention on their pancreas.
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
- Pittsburgh, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States; Pittsburgh, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.