RECRUITING

QST Study: Predicting Treatment Response in Chronic Pancreatitis Using Quantitative Sensory Testing

Conditions

Chronic Pancreatitis Chronic Pain Sphincter of Oddi Dysfunction Recurrent Acute Pancreatitis Chronic Abdominal Pain Functional Dyspepsia

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

QST Study: Predicting Treatment Response in Chronic Pancreatitis Using Quantitative Sensory Testing

Quick Facts

Study Start:2017-10-24

Study Completion:2026-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03434392

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. 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. 2. 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. 3. 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. 4. 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.	1. 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. 2. 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. 3. 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. 4. 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.

Inclusion Criteria

Exclusion Criteria

1. 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.
2. 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.
3. 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.
4. 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.

1. 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.
2. 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.
3. 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.
4. 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.

Contacts and Locations

Study Contact

Anna Evans-Phillips, MD

CONTACT

412-624-4560

evansac3@upmc.edu

Apsara Mishra

CONTACT

apm179@pitt.edu

Principal Investigator

Anna Evans-Phillips, MD

PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Study Locations (Sites)

Indiana University Medical Center

Indianapolis, Indiana, 46202

United States

Johns Hopkins Medical Institutions

Baltimore, Maryland, 21287

United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213

United States

Collaborators and Investigators

Sponsor: Anna Evans Phillips

Anna Evans-Phillips, MD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-10-24

Study Completion Date2026-06-30

Study Record Updates

Study Start Date2017-10-24

Study Completion Date2026-06-30

Terms related to this study

Keywords Provided by Researchers

Chronic Pain
Chronic Pancreatitis
Sphincter of Oddi Dysfunction
Recurrent Acute Pancreatitis
Chronic Abdominal Pain
Functional Dyspepsia

Additional Relevant MeSH Terms

Chronic Pancreatitis
Chronic Pain