PIP: Pain Phenotypes in Chronic Pancreatitis

• Sponsor: Asian Institute of Gastroenterology, India (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05713344
• Collaborator: All India Institute of Medical Sciences, New Delhi (Other), SIDS Hospital and Research Center, Surat (Other), Aalborg University Hospital (Other)
• Enrollment: 500
• Location: 1
• Anticipated Duration (Months): 18.9
• Patients Per Site Per Month: 26.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pancreatitis	Other: Clinical history; Other: Clinical examination; Other: Evaluation of quality of life; Other: Evaluation of mental state; Diagnostic Test: Pancreatic quantitative sensory testing

Study Design

• Study Type: Observational
• Anticipated Enrollment: 500 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: Evaluation of Pain Phenotypes in Chronic Pancreatitis and Identification of Clinical Surrogates of Pancreatic Neuropathy
• Actual Study Start Date: Aug 1, 2021
• Anticipated Primary Completion Date: Feb 28, 2023
• Anticipated Study Completion Date: Feb 28, 2023

Outcome Measures

Primary Outcome Measures

1. Type of pain [18 months]

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

2. Quality of life [18 months]

   EORTC QLQ c30 score

3. Mental status [18 months]

   Depression and anxiety will be determined

4. Neural sensitization [18 months]

   Presence of localised and widespread sensitisation will be determined.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Asian Institute of Gastroenterology Hospitals	Hyderabad	Telangana	India	500032

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

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.
• 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.
• 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.
• 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.

• Responsible Party: Rupjyoti Talukdar, Director, Pancreatology; Head, Pancreas Research Group and Division of Gut Microbiome Research, Asian Institute of Gastroenterology, India
• ClinicalTrials.gov Identifier: NCT05713344
• Other Study ID Numbers: PIPver01
• First Posted: Feb 6, 2023
• Last Update Posted: Feb 8, 2023
• Last Verified: Feb 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pancreatitis; Pancreatitis, Chronic

Study Results

No Results Posted as of Feb 8, 2023