Pain Phenotypes in Chronic Pancreatitis

NCT ID: NCT05713344

Last Updated: 2023-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-01

Study Completion Date

2023-02-28

Brief Summary

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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

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Conditions

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Chronic Pancreatitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Interventions

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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.

Intervention Type OTHER

Clinical examination

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

Intervention Type OTHER

Evaluation of quality of life

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

Intervention Type OTHER

Evaluation of mental state

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

Intervention Type OTHER

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Asian Institute of Gastroenterology, India

OTHER

Sponsor Role lead

All India Institute of Medical Sciences

OTHER

Sponsor Role collaborator

SIDS Hospital and Research Center, Surat

UNKNOWN

Sponsor Role collaborator

Aalborg University Hospital

OTHER

Sponsor Role collaborator

Responsible Party

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Rupjyoti Talukdar

Director, Pancreatology; Head, Pancreas Research Group and Division of Gut Microbiome Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Asian Institute of Gastroenterology Hospitals

Hyderabad, Telangana, India

Site Status RECRUITING

Countries

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India

Central Contacts

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Rupjyoti Talukdar, MD, FICP, AGAF

Role: CONTACT

+917032804231

Facility Contacts

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Rupjyoti Talukdar, MD, FICP, AGAF

Role: primary

+917032804231

Misbah Unnisa, PharmD

Role: backup

8801782828

References

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Drewes AM, Bouwense SAW, Campbell CM, Ceyhan GO, Delhaye M, Demir IE, Garg PK, van Goor H, Halloran C, Isaji S, Neoptolemos JP, Olesen SS, Palermo T, Pasricha PJ, Sheel A, Shimosegawa T, Szigethy E, Whitcomb DC, Yadav D; Working group for the International (IAP - APA - JPS - EPC) Consensus Guidelines for Chronic Pancreatitis. Guidelines for the understanding and management of pain in chronic pancreatitis. Pancreatology. 2017 Sep-Oct;17(5):720-731. doi: 10.1016/j.pan.2017.07.006. Epub 2017 Jul 13.

Reference Type BACKGROUND
PMID: 28734722 (View on PubMed)

Faghih M, Phillips AE, Kuhlmann L, Afghani E, Drewes AM, Yadav D, Singh VK, Olesen SS; Pancreatic Quantitative Sensory Testing (P-QST) Consortium. Pancreatic QST Differentiates Chronic Pancreatitis Patients into Distinct Pain Phenotypes Independent of Psychiatric Comorbidities. Clin Gastroenterol Hepatol. 2022 Jan;20(1):153-161.e2. doi: 10.1016/j.cgh.2020.10.036. Epub 2020 Oct 22.

Reference Type BACKGROUND
PMID: 34108130 (View on PubMed)

Talukdar R, Reddy DN. Pain in chronic pancreatitis: managing beyond the pancreatic duct. World J Gastroenterol. 2013 Oct 14;19(38):6319-28. doi: 10.3748/wjg.v19.i38.6319.

Reference Type BACKGROUND
PMID: 24151350 (View on PubMed)

Sarkar S, Sarkar P, M R, Hazarika D, Prasanna A, Pandol SJ, Unnisa M, Jakkampudi A, Bedarkar AP, Dhagudu N, Reddy DN, Talukdar R. Pain, depression, and poor quality of life in chronic pancreatitis: Relationship with altered brain metabolites. Pancreatology. 2022 Sep;22(6):688-697. doi: 10.1016/j.pan.2022.06.007. Epub 2022 Jun 8.

Reference Type BACKGROUND
PMID: 35710761 (View on PubMed)

Other Identifiers

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PIPver01

Identifier Type: -

Identifier Source: org_study_id

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