CClinicalTrials.gg
Status unknownNCT05713344PIPUpdated Feb 8, 2023

Pain Phenotypes in Chronic Pancreatitis

An observational study in Chronic Pancreatitis, sponsored by Asian Institute of Gastroenterology, India. Status unknown at 1 site in India. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-08.

Sponsored by Asian Institute of Gastroenterology, India · Observational

The sponsor has not verified this record recently (last verified Feb 2023), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
500
Ages
18 Years to 60 Years
Sex
All
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Study 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.

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Conditions studied

  • Chronic Pancreatitis
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In context

Pancreatitis

751 studies on the registry are indexed under Pancreatitis; 180 are open to participants now.

This study's planned enrollment of 500 is above the median of 179 across 276 observational studies indexed under Pancreatitis.

Browse Pancreatitis studies →

Lead sponsor

Asian Institute of Gastroenterology, India is the lead sponsor of 132 studies on the registry; 59 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Inclusion criteria

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

Exclusion criteria

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
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Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
500 participants (estimated)
Patient registry
No

Interventions

  • OtherClinical 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.

  • OtherClinical examination

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

  • OtherEvaluation of quality of life

    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.

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What researchers measure

Primary outcomes

  1. Type of pain

    The type of pancreatic pain, i.e nociceptive or neuropathic will be determined

    Time frame: 18 months

  2. Quality of life

    EORTC QLQ c30 score

    Time frame: 18 months

  3. Mental status

    Depression and anxiety will be determined

    Time frame: 18 months

  4. Neural sensitization

    Presence of localised and widespread sensitisation will be determined.

    Time frame: 18 months

07

Study locations

1 of 1 sites recruiting
  • Asian Institute of Gastroenterology Hospitals
    Hyderabad, Telangana 500032, India
    Recruiting
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References and documents

Publications

  • 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. PubMed 28734722 ↗
  • 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. PubMed 34108130 ↗
  • 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. PubMed 24151350 ↗
  • 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. PubMed 35710761 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05713344
Lead sponsor
Asian Institute of Gastroenterology, India
Collaborators
All India Institute of Medical Sciences, New Delhi, SIDS Hospital and Research Center, Surat, Aalborg University Hospital
Responsible party
Rupjyoti Talukdar (Director, Pancreatology; Head, Pancreas Research Group and Division of Gut Microbiome Research, Asian Institute of Gastroenterology, India) — Principal investigator
First posted
Feb 6, 2023
Start date
Aug 1, 2021
Primary completion
Feb 28, 2023 (estimated)
Completion
Feb 28, 2023 (estimated)
Last update
Feb 8, 2023

Study contacts

Rupjyoti Talukdar, MD, FICP, AGAF
Contact
rup_talukdar@yahoo.com
+917032804231

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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