NCT05713344

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2021

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 22, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 6, 2023

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

1.6 years

First QC Date

January 22, 2023

Last Update Submit

February 3, 2023

Conditions

Chronic Pancreatitis

Outcome Measures

Primary Outcomes (4)

  • Type of pain

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

    18 months

  • Quality of life

    EORTC QLQ c30 score

    18 months

  • Mental status

    Depression and anxiety will be determined

    18 months

  • Neural sensitization

    Presence of localised and widespread sensitisation will be determined.

    18 months

Interventions

Clinical historyOTHER

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.

Clinical examinationOTHER

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

Evaluation of quality of lifeOTHER

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

Evaluation of mental stateOTHER

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

Pancreatic quantitative sensory testingDIAGNOSTIC_TEST

Pancreatic quantitative sensory testing will be performed to evaluate temporal summation, pain detection threshold, pain tolerance threshold, and conditioned pain modulation.

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asian Institute of Gastroenterology Hospitals

Hyderabad, Telangana, 500032, India

RECRUITING

Related Publications (4)

  • 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.

    PMID: 28734722BACKGROUND

  • 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.

    PMID: 34108130BACKGROUND

  • 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.

    PMID: 24151350BACKGROUND

  • 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.

    PMID: 35710761BACKGROUND

MeSH Terms

Conditions

Pancreatitis, Chronic

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

PancreatitisPancreatic DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior ControlTherapeuticsImmobilizationInvestigative Techniques

Central Study Contacts

Rupjyoti Talukdar, MD, FICP, AGAF

CONTACT

+917032804231rup_talukdar@yahoo.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Pancreatology; Head, Pancreas Research Group and Division of Gut Microbiome Research

Study Record Dates

First Submitted

January 22, 2023

First Posted

February 6, 2023

Study Start

August 1, 2021

Primary Completion

February 28, 2023

Study Completion

February 28, 2023

Last Updated

February 8, 2023

Record last verified: 2023-02

Locations

IN(1)