Pain Phenotypes in Chronic Pancreatitis

Recruiting

• Conditions: Chronic Pancreatitis

• Registration Number: NCT05713344
• Lead Sponsor: Asian Institute of Gastroenterology, India

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-01
• Study First Submitted: 2023-01-22
• Study First Submitted QC: 2023-01-27
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-03
• Study First Posted: 2023-02-06
• Last Update Posted: 2023-02-08
• Primary Completion: 2023-02-28
• Study Completion: 2023-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mental status	18 months	Depression and anxiety will be determined
Neural sensitization	18 months	Presence of localised and widespread sensitisation will be determined.
Type of pain	18 months	The type of pancreatic pain, i.e nociceptive or neuropathic will be determined
Quality of life	18 months	EORTC QLQ c30 score

Trial Locations

Locations (1)

Asian Institute of Gastroenterology Hospitals; 🇮🇳 Hyderabad, Telangana, India