Clinical trial NCT05713344: Pain Phenotypes in Chronic Pancreatitis
Official title: Evaluation of Pain Phenotypes in Chronic Pancreatitis and Identification of Clinical Surrogates of Pancreatic Neuropathy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Pancreatitis
Lead sponsor: Asian Institute of Gastroenterology, India
Sponsor class: OTHER
Collaborators: name: All India Institute of Medical Sciences
name: SIDS Hospital and Research Center, Surat
name: Aalborg University Hospital
First posted: 2023-02-06
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Type of pain
timeFrame: 18 months
measure: Quality of life
timeFrame: 18 months
measure: Mental status
timeFrame: 18 months
measure: Neural sensitization
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Asian Institute of Gastroenterology Hospitals
state: Telangana
Study officials:
References:
citation: 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.
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.
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.
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.