Natural Course and Therapeutic Effect of Chronic Pancreatitis

Recruiting

• Conditions: Chronic Pancreatitis

• Registration Number: NCT06925204
• Lead Sponsor: Changhai Hospital

Brief Summary

The goal of this observational study is to establish a prospective cohort of chronic pancreatitis (CP) patients to provide evidence-based guidance for clinical practice and comprehensively optimize diagnostic and treatment strategies. The study aims to collect detailed demographic information, clinical data, medical imaging, biological samples, and follow-up information from CP patients.

Detailed Description

Chronic pancreatitis (CP) is clinically characterized by abdominal pain and pancreatic dysfunction, including diabetes and steatorrhea, which significantly impact patients' quality of life and life expectancy. Globally, the annual incidence of CP is 9.62 per 100,000 individuals, with a mortality rate of 0.09 per 100,000 and a prevalence ranging from 13.5 to 560 per 100,000. In China, the prevalence of CP has also been increasing annually, currently reaching 13.52 per 100,000 individuals. In most countries worldwide, the incidence and prevalence of CP are generally on the rise, leading to an increasing healthcare burden. Due to the endocrine and exocrine functions of the pancreas, CP presents with highly variable clinical symptoms, diverse complications, and a risk of malignant transformation. Therefore, establishing a standardized, large-scale, long-term follow-up prospective cohort for CP is crucial for a more comprehensive understanding of its clinical characteristics and for providing high-quality evidence-based medical guidance for clinical practice.

Study Timeline

• Study First Submitted: 2025-03-20
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-06
• Last Update Submitted: 2025-04-12
• Study Start: 2025-04-13
• Study First Posted: 2025-04-13
• Last Update Posted: 2025-04-15
• Primary Completion: 2035-12-01
• Study Completion: 2035-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

• Patients diagnosed with chronic pancreatitis.

Exclusion Criteria

• Patients who refuse to sign informed consent.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of complications	Annually for 10 years post-enrollment (Year 1 through Year 10)	The incidence of complications after the diagnosis of chronic pancreatitis, including diabetes mellitus, pancreatic exocrine insufficiency, pancreatic pseudocyst, biliary stricture, pancreatic portal hypertension, and pancreatic fistula.

Secondary Outcome Measures

Name	Time	Method
Blood glucose profile characteristics	Baseline and Year 1 to Year 10 post-enrollment (annually)	Blood glucose profile from mixed-meal glucose tolerance test (MMTT) and continuous glucose monitoring system (CGMS) (unit: mmol/L or mg/dL).
Pancreatic and gut hormone levels	Baseline and Year 1 to Year 10 post-enrollment (annually)	Levels of specific pancreatic hormones (C-peptide, insulin, glucagon, etc.) and gut hormones (ghrelin, gastric inhibitory peptide, glucagon like peptide-1, etc.) measured in venous blood (unit: specify for each hormone).
Incidence of pancreatic cancer	5 and 10 years after enrollment	The incidence of pancreatic cancer after the diagnosis of chronic pancreatitis
Efficacy of endoscopic treatment	1 year after treatment	Proportion of patients with chronic pancreatitis who had pain relief after conservative, endoscopic (ESWL and ERCP), or surgical treatment
Scores of quality of life	Annually for 10 years post-enrollment (Year 1 through Year 10)	Quality of life scores for patients with chronic pancreatitis are obtained using SF-36 (36-Item Short Form Health Survey) which contains 8 dimensions scored from 0 to 100 (standardized converted scores). The higher score means better function.
HbA1c level	Baseline and Year 1 to Year 10 post-enrollment (annually)	Glycated hemoglobin (HbA1c) level measured in venous blood (unit: %).

Trial Locations

Locations (1)

Changhai Hospital; 🇨🇳 Shanghai, Shanghai, China