Neural Sensitisation and Neuropsychological Alterations in Painful Chronic Pancreatitis

NCT07707609 | Recruiting

• 1 other identifier: NACP1
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic pancreatitis (CP) is a progressive inflammatory disease in which chronic abdominal pain affects up to 80% of patients and remains difficult to manage despite treatment of pancreatic pathology. Increasing evidence suggests that persistent pain is not solely driven by peripheral pancreatic abnormalities but also by central sensitization, involving maladaptive changes in central nervous system pain-processing pathways. While altered brain connectivity and neurochemical changes have been demonstrated in other chronic pain disorders, these mechanisms remain poorly characterized in CP. This study aims to integrate clinical phenotyping with blood-based metabolite profiling and advanced neuroimaging, including resting-state functional MRI and magnetic resonance spectroscopy, to investigate the relationship between central sensitization, brain dysfunction, and neuropsychological alterations. The findings may identify objective neurobiological markers of pain and facilitate the development of mechanism-based, personalized treatment strategies for patients with chronic pancreatitis.

Conditions

Chronic Pancreatitis; Pain Management

Keywords

Central Sensitisation; Pain; Neuroimaging; fMRI; MRS; Chronic Pancreatitis

Outcome Measures

Primary Outcomes (1)

• Role of Central Sensitization

  To evaluate the role of central sensitization and its neuropsychological correlates on pain in patients with chronic pancreatitis (CP) compared to painless CP and healthy controls

  At the time of the single study visit

Secondary Outcomes (3)

• Brain Connectivity

  At the time of the single study visit.

• Brain Metabolites

  At the time of the single study visit.

• Quantification of Blood-Based Metabolites

  At the time of the single study visit.

Study Arms (3)

Painful Chronic Pancreatitis

Patients diagnosed with chronic pancreatitis (CP) confirmed by CECT, MRCP, or EUS (based on Cambridge or Rosemont criteria), who experience significant abdominal pain.

Diagnostic Test: Comprehensive Neuropsychological Assessment; Diagnostic Test: Resting-State Functional MRI (fMRI); Diagnostic Test: Magnetic Resonance Spectroscopy (MRS); Diagnostic Test: Blood-Based Metabolite Profiling

Painless Chronic Pancreatitis

Patients diagnosed with chronic pancreatitis who do not experience abdominal pain, serving as a disease control group

Diagnostic Test: Comprehensive Neuropsychological Assessment; Diagnostic Test: Resting-State Functional MRI (fMRI); Diagnostic Test: Magnetic Resonance Spectroscopy (MRS); Diagnostic Test: Blood-Based Metabolite Profiling

Healthy Controls

Age- and sex-matched individuals without any pancreatic or systemic diseases, serving as a healthy control group

Diagnostic Test: Comprehensive Neuropsychological Assessment; Diagnostic Test: Resting-State Functional MRI (fMRI); Diagnostic Test: Magnetic Resonance Spectroscopy (MRS); Diagnostic Test: Blood-Based Metabolite Profiling

Interventions

Comprehensive Neuropsychological Assessment DIAGNOSTIC_TEST

A comprehensive set of clinical and neurological tests to be performed on all participants. This includes validated mental state and sleep evaluations (HADS, PSQI), quality-of-life assessments (EORTC QLQ-C30 + PAN28),and quantitative sensory testing (P-QST)

Healthy Controls; Painful Chronic Pancreatitis; Painless Chronic Pancreatitis

Resting-State Functional MRI (fMRI) DIAGNOSTIC_TEST

An advanced neuroimaging scan performed on all participants to assess resting-state functional connectivity within key pain-processing networks.

Healthy Controls; Painful Chronic Pancreatitis; Painless Chronic Pancreatitis

Magnetic Resonance Spectroscopy (MRS) DIAGNOSTIC_TEST

A neuroimaging technique performed on all participants to quantify brain metabolites in key brain regions.

Healthy Controls; Painful Chronic Pancreatitis; Painless Chronic Pancreatitis

Blood-Based Metabolite Profiling DIAGNOSTIC_TEST

Blood samples will be collected from all participants to quantify metabolomic signatures and to identify potential correlates with pain phenotypes in chronic pancreatitis.

Healthy Controls; Painful Chronic Pancreatitis; Painless Chronic Pancreatitis

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Adult participants aged 18-60 years with diagnosed chronic pancreatitis and healthy controls

You may qualify if:

• Diagnosed with CP confirmed by CECT, MRCP, or EUS based on Cambridge or Rosemont criteria.
• Age 18-60 years.
• Both genders

You may not qualify if:

• Recent episode of acute pancreatitis or ongoing pain (VAS \>5).
• Pancreatic cancer and other significant comorbidities.
• Recent use of antidepressants, anxiolytics, high-potency opioids, or neuromodulators.
• Pregnancy and lactation.
• Inability to give informed consent.

Sponsors & Collaborators

• Asian Institute of Gastroenterology, India: lead

Study Sites (1)

Asian Institute of Gastroenterology

Hyderabad, Telangana, 500032, India

RECRUITING

Related Publications (6)

• Dimcevski G, Sami SA, Funch-Jensen P, Le Pera D, Valeriani M, Arendt-Nielsen L, Drewes AM. Pain in chronic pancreatitis: the role of reorganization in the central nervous system. Gastroenterology. 2007 Apr;132(4):1546-56. doi: 10.1053/j.gastro.2007.01.037. Epub 2007 Jan 25.

  PMID: 17408654 RESULT

• 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: 34108130 RESULT

• 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: 35710761 RESULT

• Keller CE, Wilcox CM, Gudleski GD, Branham S, Lackner JM. Beyond Abdominal Pain: Pain Beliefs, Pain Affect, and Distress as Determinants of Quality of Life in Patients With Chronic Pancreatitis. J Clin Gastroenterol. 2018 Jul;52(6):563-568. doi: 10.1097/MCG.0000000000000922.

  PMID: 28858939 RESULT

• Phillips AE, Faghih M, Drewes AM, Singh VK, Yadav D, Olesen SS; Pancreatic Quantitative Sensory Testing (P-QST) Consortium. Psychiatric Comorbidity in Patients With Chronic Pancreatitis Associates With Pain and Reduced Quality of Life. Am J Gastroenterol. 2020 Dec;115(12):2077-2085. doi: 10.14309/ajg.0000000000000782.

  PMID: 32740078 RESULT

• 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: 24151350 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum.

MeSH Terms

Conditions

Pancreatitis, Chronic; Agnosia; Pain

Interventions

Positron-Emission Tomography

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Image Enhancement; Photography; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Pancreatology

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 16, 2026
• Study Start: January 6, 2026
• Primary Completion (Estimated): November 6, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: July 16, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)