Clinical trial NCT06996535: Pancreatic Quantitative Sensory Testing (P-QST)
Official title: Pancreatic Quantitative Sensory Testing (P-QST) in Pediatric Patients With Acute Recurrent Pancreatitis and Chronic Pancreatitis: Evaluation and Prediction of Treatment Response
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Chronic Pancreatitis
Chronic Pain
Acute Recurrent Pancreatitis
Keywords: Pediatric
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2025-05-30
Enrollment: 60
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Stratified Sampling

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 3, 6, and 12 months post-procedure for evaluation of changes in their pain profile.

Eligibility criteria: Subjects with no pancreatic disease and no abdominal pain.

Inclusion Criteria:

* Subjects are 5 years to 17 years old
* Subject and or legal guardian is willing and able to comply with the scheduled visits, questionnaires, treatment plan, and other study procedures.
* 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 ARP or CP from chronic pain of other origins.

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 that make them unable to distinguish the pain associated with ARP or CP from chronic pain of other origins.

Definite Chronic Pancreatitis

Inclusion Criteria: • Subjects are 5 years to 17 years old

* Subjects will have a prior confirmed diagnosis of CP on CT scan or MRI/MRCP according to Cambridge Classification (grade 3 or 4)
* Subjects and or legal guardian willing and able to comply with the scheduled visits, questionnaires, and other study procedures.

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 enrollment.

Primary outcomes:
measure: Pain Pattern Assessment
timeFrame: day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Childrens Hospital Medical Center
state: Ohio
Study officials:
affiliation: Cincinnati Childrens Hospital Medical Center
name: Juan Gurria
role: PRINCIPAL_INVESTIGATOR
References: