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Pancreatic Quantitative Sensory Testing (P-QST)

Pancreatic Quantitative Sensory Testing (P-QST) in Pediatric Patients With Acute Recurrent Pancreatitis and Chronic Pancreatitis: Evaluation and Prediction of Treatment Response

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06996535
Enrollment
60
Registered
2025-05-30
Start date
2024-08-01
Completion date
2028-05-01
Last updated
2025-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Recurrent Pancreatitis, Chronic Pain, Chronic Pancreatitis

Keywords

Pediatric

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.

Interventions

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.

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.

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.

Sponsors

Children's Hospital Medical Center, Cincinnati
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
5 Years to 17 Years
Healthy volunteers
Yes

Inclusion 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.

Design outcomes

Primary

MeasureTime frameDescription
Pain Pattern Assessmentday 1Pain Pattern Assessment as assessed by the combination of Temporal Summation score, Sensitization score, and Conditioned Pain Modulation score

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026