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

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.

Inclusion 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.

Exclusion Criteria:

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.