Pain Phenotypes in Chronic Pancreatitis

Chronic Pancreatitis Clinical Trial

— PIP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05713344
• Other study ID #: PIPver01
• Status: Recruiting
• Start date: August 1, 2021
• Est. completion date: February 28, 2023

Study information

• Verified date: February 2023
• Source: Asian Institute of Gastroenterology, India
• Contact: Rupjyoti Talukdar, MD, FICP, AGAF
• Phone: +917032804231
• Email: rup_talukdar[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: February 28, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pancreatitis
• Pancreatitis
• Pancreatitis, Chronic

Intervention

Other:
• 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.
• Clinical examination
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 life
Use of the EORTC QLQ c30 with PAN 28 to evaluate quality of life
• Evaluation of mental state
Use of Beck depression inventory and Hospital Anxiety Depression score to evaluate depression and anxiety

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
India	Asian Institute of Gastroenterology Hospitals	Hyderabad	Telangana

Sponsors (4)

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

Country where clinical trial is conducted

India, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

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