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Pain Phenotypes in Chronic Pancreatitis

Evaluation of Pain Phenotypes in Chronic Pancreatitis and Identification of Clinical Surrogates of Pancreatic Neuropathy

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05713344
Acronym
PIP
Enrollment
500
Registered
2023-02-06
Start date
2021-08-01
Completion date
2023-02-28
Last updated
2023-02-08

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

Conditions

Chronic Pancreatitis

Brief summary

Chronic pancreatitis (CP) is characterised by recurrent abdominal pain. The pathological hallmarks of CP is pancreatic stellate cell activation that results in persistent inflammation and progressive fibrosis. It has been shown in various clinical and experimental studies that with disease progression there could be pancreatic neural inflammation, spinal sensitization and eventually alteration in the pain modulating architecture within the brain (widespread sensitization). These events result in different types of pain (nociceptive and neuropathic) in patients with CP, which may dynamically change during disease progression. Since the treatment for different mechanisms are unique, it becomes important to identify the predominant type of pain. Recently, pancreatic quantitative sensory testing (P-QST) has emerged as a valuable tool to identify different types of sensitization. This facility is currently available only in select centers and is being conducted under research protocols. In this study, we propose to: 1. evaluate the patterns of pain in CP and the triggers; 2. identify clinical surrogates of sensitization, i.e. neuropathic pain. The ultimate goal is to apply the best possible pain management strategy based on our research findings for patients with CP in a personalised manner.

Interventions

Detailed clinical history including demographic details, pain details (character, pattern, location, change in character, involvement of new areas), duration of disease, co-morbidities, family history, adverse life events, sleep details, details of stress/anxiety.

OTHERClinical examination

Thorough clinical examination, anthropometric measurement, assessment of pain (Izbicki score, Visual analog scale, modified brief pain inventory, pain catastrophising score, painDetect)

Use of the EORTC QLQ c30 with PAN 28 to evaluate quality of life

OTHEREvaluation of mental state

Use of Beck depression inventory and Hospital Anxiety Depression score to evaluate depression and anxiety

DIAGNOSTIC_TESTPancreatic quantitative sensory testing

Pancreatic quantitative sensory testing will be performed to evaluate temporal summation, pain detection threshold, pain tolerance threshold, and conditioned pain modulation.

Sponsors

All India Institute of Medical Sciences
CollaboratorOTHER
SIDS Hospital and Research Center, Surat
CollaboratorUNKNOWN
Aalborg University Hospital
CollaboratorOTHER
Asian Institute of Gastroenterology, India
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

* At least 3 years of disease (chronic pancreatitis) * Both genders * Able to provide informed consent

Exclusion criteria

* Acute exacerbation of chronic pancreatitis * Moderate to severe abdominal pain at the time of screening * Pancreatic cancer or other malignancies * Use of antidepressants, narcotics, and neuromodulators

Design outcomes

Primary

MeasureTime frameDescription
Type of pain18 monthsThe type of pancreatic pain, i.e nociceptive or neuropathic will be determined
Quality of life18 monthsEORTC QLQ c30 score
Mental status18 monthsDepression and anxiety will be determined
Neural sensitization18 monthsPresence of localised and widespread sensitisation will be determined.

Countries

India

Contacts

Primary ContactRupjyoti Talukdar, MD, FICP, AGAF
rup_talukdar@yahoo.com+917032804231

Outcome results

None listed

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