Pain Phenotypes in Chronic Pancreatitis (PIP)

February 3, 2023 updated by: Rupjyoti Talukdar, Asian Institute of Gastroenterology, India

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • India
    • Telangana
      • Hyderabad, Telangana, India, 500032
        • Recruiting
        • Asian Institute of Gastroenterology Hospitals
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with documented CP will be screened for enrolment criteria. Those fulfilling criteria will be enrolled after written informed consent.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asian Institute of Gastroenterology, India

Collaborators

All India Institute of Medical Sciences, New Delhi
Aalborg University Hospital
SIDS Hospital and Research Center, Surat

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2021

Primary Completion (ANTICIPATED)

February 28, 2023

Study Completion (ANTICIPATED)

February 28, 2023

Study Registration Dates

First Submitted

January 22, 2023

First Submitted That Met QC Criteria

January 27, 2023

First Posted (ACTUAL)

February 6, 2023

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 3, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PIPver01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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