Personalized Education and Pain Response in Chronic Pancreatitis

NCT04654377 | Not Yet Recruiting DMC

• 1 other identifier: PEPCP2023 ver 04
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

Pain mechanisms in chronic pancreatitis (CP) are heterogeneous and includes nociception, pancreatic neuropathy and central neuropathy/neuroplasty. These mechanisms could occur simultaneously in variable proportions and could explain why several patients develop recurrence of pain even after being treated by all the currently available modalities, such as antioxidants, endoscopic therapies and surgery. In the studies by the investigators over the past 2 years, they observed that persistent pain in these patients was associated with varying grades of depression and poor quality of life. This was accompanied by alteration in the metabolites in the brain (anterior cingulate cortex, prefrontal cortex, hippocampus, and basal ganglia) as evidenced in magnetic resonance spectroscopy (MRS) of the brain. These areas in the brain are responsible for pain modulation, long-term pain memory and emotional responses to pain. When the investigators counselled these patients and explained their disease and possible outcomes based on their own clinical course, imaging and treatment response (personalized education/counselling), they reported significant improvement in depression, quality of life parameters and, interestingly, also in pain. Further, there were changes in the metabolite parameters in the brain on MRS after personalized counselling/education that was more similar to that of healthy controls. This led to our hypothesis that better understanding of the disease and its outcomes by the patients could improve their coping capabilities and increase their pain thresholds. This could augment the pain responses of these patients to the other therapeutic modalities. We will conduct this single blinded, placebo controlled, randomized controlled trial on patients with documented CP of over 3 years duration, who had at least 3 episodes of abdominal pain of over the past 3 months.

Conditions

Chronic Pancreatitis; Pain Syndrome; Depression, Anxiety

Keywords

chronic pancreatitis; pain; depression; anxiety; quality of life; metabolome; magnetic resonance spectroscopy; quantitative sensory testing

Outcome Measures

Primary Outcomes (1)

• Change in pain score

  Pain will be measured using the Visual analog scale (0-10)

  3 and 6 months

Secondary Outcomes (12)

• Change in number of painful days

  3 and 6 months

• Change in the number of hospital visits

  3 and 6 months

• Change in neuropathic pain

  3 and 6 months

• Change in quality of life (QOL)

  3 and 6 months

• Change in depression score

  3 and 6 months

Other Outcomes (1)

• Evaluation of possible mechanisms of improvement.

  3 and 6 months

Study Arms (2)

Personalised education

EXPERIMENTAL

1. Greetings. 2. Recording of demographic, clinical (disease related), nutritional, laboratory, and treatment related data. 3. Administration of questionnaires. 4. Inquiring patient's perception of their disease. 5. Explaining the patient about their disease in general followed by specific aspects and possible outcomes in the context of their perception, clinical aspects, questionnaire, and imaging data. In addition, the general treatment plan will be explained. 6. Address all queries from the patient and care givers.

Other: Personalised education

Standard communication

NO INTERVENTION

1. Greetings. 2. Recording of demographic, clinical (disease related), nutritional, laboratory, imaging and treatment related data. 3. Administration of questionnaires. 4. Explaining the general treatment plan. 5. Address general treatment related queries from the patient and care givers.

Interventions

Personalised education OTHER

Patients will be explained about their disease and possible outcomes based on clinical, biochemical and imaging data.

Personalised education

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Chronic pancreatitis of at least 3 years
• At least 3 episodes of pain in the past 3 months
• Age 18-60yrs
• Both genders

You may not qualify if:

• Acute pancreatitis episode at the time of enrolment.
• Pancreatic cancer.
• Other chronic diseases (including end organ damage related to diabetes).
• Adverse life event in the family in the past 6 months.
• Active substance use (alcohol, smoking, smokeless tobacco, Illicit drugs).
• Pregnancy and lactation.
• Psychiatric illness at enrolment or during follow-up, and/or concomitant intake of antidepressants and neuromodulators..

Sponsors & Collaborators

• Asian Institute of Gastroenterology, India: lead

Study Sites (1)

Asian Institute of Gastroenterology

Hyderabad, Telangana, 500032, India

Location

Related Publications (12)

• 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 BACKGROUND

• Talukdar R, Nageshwar Reddy D. Is there a single therapeutic target for chronic pancreatitis pain? Gastroenterology. 2013 Mar;144(3):e18. doi: 10.1053/j.gastro.2012.12.033. Epub 2013 Jan 25. No abstract available.

  PMID: 23357056 BACKGROUND

• 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 BACKGROUND

• Ceyhan GO, Demir IE, Rauch U, Bergmann F, Muller MW, Buchler MW, Friess H, Schafer KH. Pancreatic neuropathy results in "neural remodeling" and altered pancreatic innervation in chronic pancreatitis and pancreatic cancer. Am J Gastroenterol. 2009 Oct;104(10):2555-65. doi: 10.1038/ajg.2009.380. Epub 2009 Jun 30.

  PMID: 19568227 BACKGROUND

• Nguyen-Tang T, Dumonceau JM. Endoscopic treatment in chronic pancreatitis, timing, duration and type of intervention. Best Pract Res Clin Gastroenterol. 2010 Jun;24(3):281-98. doi: 10.1016/j.bpg.2010.03.002.

  PMID: 20510829 BACKGROUND

• Talukdar R, Murthy HV, Reddy DN. Role of methionine containing antioxidant combination in the management of pain in chronic pancreatitis: a systematic review and meta-analysis. Pancreatology. 2015 Mar-Apr;15(2):136-44. doi: 10.1016/j.pan.2015.01.003. Epub 2015 Jan 21.

  PMID: 25648074 BACKGROUND

• Olesen SS, Bouwense SA, Wilder-Smith OH, van Goor H, Drewes AM. Pregabalin reduces pain in patients with chronic pancreatitis in a randomized, controlled trial. Gastroenterology. 2011 Aug;141(2):536-43. doi: 10.1053/j.gastro.2011.04.003. Epub 2011 Apr 14.

  PMID: 21683078 BACKGROUND

• Bloechle C, Izbicki JR, Knoefel WT, Kuechler T, Broelsch CE. Quality of life in chronic pancreatitis--results after duodenum-preserving resection of the head of the pancreas. Pancreas. 1995 Jul;11(1):77-85. doi: 10.1097/00006676-199507000-00008.

  PMID: 7667246 BACKGROUND

• Hallstrom H, Norrbrink C. Screening tools for neuropathic pain: can they be of use in individuals with spinal cord injury? Pain. 2011 Apr;152(4):772-779. doi: 10.1016/j.pain.2010.11.019. Epub 2011 Jan 26.

  PMID: 21272997 BACKGROUND

• Fitzsimmons D, Kahl S, Butturini G, van Wyk M, Bornman P, Bassi C, Malfertheiner P, George SL, Johnson CD. Symptoms and quality of life in chronic pancreatitis assessed by structured interview and the EORTC QLQ-C30 and QLQ-PAN26. Am J Gastroenterol. 2005 Apr;100(4):918-26. doi: 10.1111/j.1572-0241.2005.40859.x.

  PMID: 15784041 BACKGROUND

• • S Sarkar, D Hazarika, A Adak, P Sarkar, M Khan, NR Duvvur, R Talukdar. Impact of Personalized Counseling on Depression and Quality of Life in Patients with Chronic Pancreatitis: Results from a Randomized Controlled Trial Gastroenterology 156 (6), S-166.

  BACKGROUND

• • S Sarkar, N Reddy, R Talukdar. Determinants of depression and its impact on quality of life in patients with chronic pancreatitis. Gut 67 (Suppl 2), A79-A80.

  BACKGROUND

MeSH Terms

Conditions

Pancreatitis, Chronic; Somatoform Disorders; Depression; Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavioral Symptoms; Behavior; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Rupjyoti Talukdar, MD, FICP, AGAF

  Asian Institute of Gastroenterology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rupjyoti Talukdar, MD, FICP, AGAF

CONTACT

7032804231; rup_talukdar@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• 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: November 27, 2020
• First Posted: December 4, 2020
• Study Start: August 1, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: After completion of study to one year thereafter.
• Access Criteria: Collaborative study with similar study design/outcomes

Locations

IN (1)