Clinical trial NCT06925204: Natural Course and Therapeutic Effect of Chronic Pancreatitis
Official title: Natural Course and Therapeutic Effect of Chronic Pancreatitis: a Prospect Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Pancreatitis
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Changzheng Hospital
First posted: 2025-04-13
Enrollment: 5000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Chronic pancreatitis patients in China.

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.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with chronic pancreatitis.

Exclusion Criteria:

* Patients who refuse to sign informed consent.

Primary outcomes:
measure: Incidence of complications
timeFrame: Annually for 10 years post-enrollment (Year 1 through Year 10)
Secondary outcomes:
measure: Incidence of pancreatic cancer
timeFrame: 5 and 10 years after enrollment
measure: Efficacy of endoscopic treatment
timeFrame: 1 year after treatment
measure: Scores of quality of life
timeFrame: Annually for 10 years post-enrollment (Year 1 through Year 10)
measure: HbA1c level
timeFrame: Baseline and Year 1 to Year 10 post-enrollment (annually)
measure: Blood glucose profile characteristics
timeFrame: Baseline and Year 1 to Year 10 post-enrollment (annually)
measure: Pancreatic and gut hormone levels
timeFrame: Baseline and Year 1 to Year 10 post-enrollment (annually)
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
state: Shanghai
Study officials:
affiliation: Changhai Hospital
name: Zhaoshen Li, M.D.
role: STUDY_CHAIR
References:
citation: Kichler A, Jang S. Chronic Pancreatitis: Epidemiology, Diagnosis, and Management Updates. Drugs. 2020 Aug;80(12):1155-1168. doi: 10.1007/s40265-020-01360-6.
citation: Oh TK, Song IA. Five-year mortality trends associated with chronic pancreatitis in South Korea: A population based cohort study. Pancreatology. 2020 Jul;20(5):828-833. doi: 10.1016/j.pan.2020.04.024. Epub 2020 Jun 18.
citation: Sellers ZM, MacIsaac D, Yu H, Dehghan M, Zhang KY, Bensen R, Wong JJ, Kin C, Park KT. Nationwide Trends in Acute and Chronic Pancreatitis Among Privately Insured Children and Non-Elderly Adults in the United States, 2007-2014. Gastroenterology. 2018 Aug;155(2):469-478.e1. doi: 10.1053/j.gastro.2018.04.013. Epub 2018 Apr 13.
citation: Wang LW, Li ZS, Li SD, Jin ZD, Zou DW, Chen F. Prevalence and clinical features of chronic pancreatitis in China: a retrospective multicenter analysis over 10 years. Pancreas. 2009 Apr;38(3):248-54. doi: 10.1097/MPA.0b013e31818f6ac1.