NCT04654377: PEPCP

Personalized Education and Pain Response in Chronic Pancreatitis

Not yet recruiting NA Last updated 30 July 2025

What this trial tests

NA trial testing Personalised education in Chronic Pancreatitis in 114 participants. Not yet recruiting.

Timeline

1 August 2025

Primary endpoint
31 July 2026

31 December 2026

Quick facts

Lead sponsor	Asian Institute of Gastroenterology, India
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	114
Start date	1 August 2025
Primary completion	31 July 2026
Estimated completion	31 December 2026
Sites	1 location across India

Drugs / interventions tested

• Personalised education

Conditions studied

• Chronic Pancreatitis — all drugs for Chronic Pancreatitis →
• Pain Syndrome — all drugs for Pain Syndrome →
• Depression, Anxiety — all drugs for Depression, Anxiety →

Sponsor

Asian Institute of Gastroenterology, India

Who can join

Adults 18 to 60, any sex, with Chronic Pancreatitis or Pain Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Management of chronic pancreatitis: recent advances and future prospects.
   Han C, Lv YW, Hu LH. · · 2024 · cited 5× · PMID 38406795 · DOI 10.1177/17562848241234480