NCT05713344

Pain Phenotypes in Chronic Pancreatitis

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Asian Institute of Gastroenterology, India · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Chronic Pancreatitis

Interventions

Type	Name	Description
OTHER	Clinical history	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.
OTHER	Clinical examination	Thorough clinical examination, anthropometric measurement, assessment of pain (Izbicki score, Visual analog scale, modified brief pain inventory, pain catastrophising score, painDetect)
OTHER	Evaluation of quality of life	Use of the EORTC QLQ c30 with PAN 28 to evaluate quality of life
OTHER	Evaluation of mental state	Use of Beck depression inventory and Hospital Anxiety Depression score to evaluate depression and anxiety
DIAGNOSTIC_TEST	Pancreatic quantitative sensory testing	Pancreatic quantitative sensory testing will be performed to evaluate temporal summation, pain detection threshold, pain tolerance threshold, and conditioned pain modulation.

Timeline

• Start date: 2021-08-01
• Primary completion: 2023-02-28
• Completion: 2023-02-28
• First posted: 2023-02-06
• Last updated: 2023-02-08

Locations

1 site across 1 country: India