Back to results

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

Primary Purpose

Chronic Pancreatitis, Chronic Pain

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Quantitative Sensory Test 1

Quantitative Sensory Test 2

Quantitative Sensory Test 3

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

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Arm Type

Active Comparator

Arm Label

Healthy Controls

Suspected CP

Definite CP

Sphincter of Oddi Dysfunction or Functional Dyspepsia

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Assignment to one of four groups (Segmental Sensitization, Systemic Sensitization, Impaired Conditioned Pain Modulation, or Other) based on combination of patient-reported pain symptoms. Temporal summation pain symptoms are measured on visual analogue scales which are measured from 0 (minimum) to 10 (maximum). 10 on this scale indicates worse pain; 0 indicates no pain. Sensitization scores are measured via patient reported thresholds in kilopascals. Conditioned Pain modulation is measured also via patient reported threshold in kilopascals.

Secondary Outcome Measures

Change in Mean Pain score

In Definite CP Patients undergoing endotherapy as part of regular clinical care, assessment of mean pain level for 7 days prior to endotherapy will be assessed immediately pre-procedure and again at 90 days post-procedure. A pain reduction of >30% in 90 days after procedure will be characterized as positive response to procedure.

Full Information

NCT ID

NCT03434392

First Posted

November 3, 2017

Last Updated

December 18, 2022

Sponsor

Anna Evans Phillips

Collaborators

Johns Hopkins University, Aalborg University

1. Study Identification

Unique Protocol Identification Number

NCT03434392

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Recruiting

Study Start Date

October 24, 2017 (Actual)

Primary Completion Date

November 15, 2023 (Anticipated)

Study Completion Date

November 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Anna Evans Phillips

Collaborators

Johns Hopkins University, Aalborg University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

Detailed Description

In Chronic Pancreatitis (CP), clinical pain symptoms correlate poorly with pancreatic ductal morphology, response to endoscopic or surgical therapy is unpredictable, and the rationale for invasive therapies is often questioned. Quantitative sensory testing (QST) is a technique used to map the pain system based on the rationale that different neural pathways and networks can be explored using standardized stimulation and simultaneous recording of the evoked pain response by psychophysical and/or objective methods. In this study, the investigators aim to distinguish phenotypes characterized by segmental sensitization of the pancreatic viscerotome, and systemic sensitization with pathological central pain processing. The investigators will perform QST on controls and CP subjects consisting of stimulation in several different dermatomes including pancreatic and control areas. All subjects will also answer standardized questionnaires assessing pain, depression, anxiety, and quality of life at baseline. Subjects undergoing endoscopic or surgical therapy will also undergo follow-up testing consisting of the same tests at 1, 3, and 6 months post-procedure for evaluation of changes in their pain profile.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Pancreatitis, Chronic Pain

Keywords

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Participants are assigned to one of four groups in parallel for the duration of the study based on prior clinical history.

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Healthy Controls

Arm Type

Active Comparator

Arm Description

Arm Title

Suspected CP

Arm Type

Active Comparator

Arm Description

Arm Title

Definite CP

Arm Type

Active Comparator

Arm Description

Arm Title

Sphincter of Oddi Dysfunction or Functional Dyspepsia

Arm Type

Active Comparator

Arm Description

Intervention Type

Diagnostic Test

Intervention Name(s)

Quantitative Sensory Test 1

Other Intervention Name(s)

Temporal Summation

Intervention Description

Subject will give pain rating (on Visual Analogue Scale (VAS) 0-10) of single as well as multiple stimulation with round-tip non-invasive pin-prick device. Difference is recorded as Temporal Summation Score.

Intervention Type

Diagnostic Test

Intervention Name(s)

Quantitative Sensory Test 2

Other Intervention Name(s)

Segmental v Systemic Sensitization

Intervention Description

Subject will state when they first detect pain and pain detection threshold in response to pressure administration with pressure algometer. Pressure threshold recorded in kilopascals(kP). Stimulation will be repeated in pancreatic and control dermatomes. Subject will then state pain tolerance threshold at same locations. Sensitization will be characterized by ratio of pancreatic vs. control dermatome scores.

Intervention Type

Diagnostic Test

Intervention Name(s)

Quantitative Sensory Test 3

Other Intervention Name(s)

Conditioned Pain Modulation

Intervention Description

Subject will apply dominant hand to ice-chilled water bath (36F) for up to 2 minutes. Pain score (VAS 0-10) will be assessed each 10 seconds. Pain tolerance threshold (in kP) will be assessed with algometer on non-dominant thigh before and after water bath to determine change in threshold. Difference in pain tolerance recorded as Conditioned Pain Modulation Score.

Primary Outcome Measure Information:

Title

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

Description

Time Frame

One-time baseline testing

Secondary Outcome Measure Information:

Title

Change in Mean Pain score

Description

Time Frame

90 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Anna Evans-Phillips, MD

Phone

412-624-4560

evansac3@upmc.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Tina Tomko

Phone

412-647-1120

tomkot@upmc.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anna Evans-Phillips, MD

Organizational Affiliation

University of Pittsburgh

Official's Role

Principal Investigator

Facility Information:

Facility Name

Indiana University Medical Center

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ashleigh Hallam

Phone

317-278-9207

amhallam@iu.edu

First Name & Middle Initial & Last Name & Degree

Benjamin Lo Bick, MD

Facility Name

Johns Hopkins Medical Institutions

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mahya Faghih, M.D.

Phone

410-614-6708

mfaghih2@jhu.edu

First Name & Middle Initial & Last Name & Degree

Vikesh K. Singh, M.D.

Facility Name

University of Pittsburgh Medical Center

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Anna Evans-Phillips, MD

Phone

412-624-4560

evansac3@upmc.edu

First Name & Middle Initial & Last Name & Degree

Dhiraj Yadav, MD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34860815

Citation

Phillips AE, Faghih M, Singh VK, Olesen SS, Kuhlmann L, Novovic S, Bick B, Hart PA, Ramsey ML, Talukdar R, Garg PK, Yadav D, Drewes AM; Pancreatic Quantitative Sensory Testing (P-QST) Consortium. Rationale for and Development of the Pancreatic Quantitative Sensory Testing Consortium to Study Pain in Chronic Pancreatitis. Pancreas. 2021 Oct 1;50(9):1298-1304. doi: 10.1097/MPA.0000000000001912.

Results Reference

derived

PubMed Identifier

34675068

Citation

Olesen SS, Phillips AE, Faghih M, Kuhlmann L, Steinkohl E, Frokjaer JB, Bick BL, Ramsey ML, Hart PA, Garg PK, Singh VK, Yadav D, Drewes AM; Pancreatic Quantitative Sensory Testing (P-QST) Consortium. Overlap and cumulative effects of pancreatic duct obstruction, abnormal pain processing and psychological distress on patient-reported outcomes in chronic pancreatitis. Gut. 2022 Dec;71(12):2518-2525. doi: 10.1136/gutjnl-2021-325855. Epub 2021 Oct 21.

Results Reference

derived

PubMed Identifier

31787527

Citation

Phillips AE, Faghih M, Kuhlmann L, Larsen IM, Drewes AM, Singh VK, Yadav D, Olesen SS; Pancreatic Quantitative Sensory Testing (P-QST) Consortium. A clinically feasible method for the assessment and characterization of pain in patients with chronic pancreatitis. Pancreatology. 2020 Jan;20(1):25-34. doi: 10.1016/j.pan.2019.11.007. Epub 2019 Nov 20.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs