Natural Course and Therapeutic Effect of Chronic Pancreatitis
1 other identifier
observational
5,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2025
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 20, 2025
CompletedFirst Posted
Study publicly available on registry
April 13, 2025
CompletedStudy Start
First participant enrolled
April 13, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2035
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2035
April 15, 2025
April 1, 2025
10.6 years
March 20, 2025
April 12, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of complications
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.
Annually for 10 years post-enrollment (Year 1 through Year 10)
Secondary Outcomes (6)
Incidence of pancreatic cancer
5 and 10 years after enrollment
Efficacy of endoscopic treatment
1 year after treatment
Scores of quality of life
Annually for 10 years post-enrollment (Year 1 through Year 10)
HbA1c level
Baseline and Year 1 to Year 10 post-enrollment (annually)
Blood glucose profile characteristics
Baseline and Year 1 to Year 10 post-enrollment (annually)
- +1 more secondary outcomes
Study Arms (1)
chronic pancreatitis
This group included all enrolled patients with CP.
Interventions
Based on the patient's specific clinical condition, the appropriate examination and treatment in accordance with the conventional diagnosis and treatment standards of CP will be performed, including but not limited to: CT, MRI, endoscopic ultrasound (EUS) with or without biopsy, endocrine hormone testing (such as oral glucose tolerance test or mixed meal tolerance testing), pancreatic exocrine function tests (such as fecal elastase-1 test), extracorporeal shock wave lithotripsy (ESWL), endoscopic retrograde cholangiopancreatography (ERCP), and pancreatic enzyme replacement therapy. Patients were followed up regularly.
Eligibility Criteria
Chronic pancreatitis patients in China.
You may qualify if:
- Patients diagnosed with chronic pancreatitis.
You may not qualify if:
- Patients who refuse to sign informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Changhai Hospitallead
- Shanghai Changzheng Hospitalcollaborator
Study Sites (1)
Changhai Hospital
Shanghai, Shanghai Municipality, China
Related Publications (4)
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.
PMID: 32647920RESULTOh 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.
PMID: 32646739RESULTSellers 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.
PMID: 29660323RESULTWang 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.
PMID: 19034057RESULT
Biospecimen
The patient's stool, blood, urine, pancreatic tissue and pancreatic stones generated during the diagnosis and treatment will be retained.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Zhaoshen Li, M.D.
Changhai Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 20, 2025
First Posted
April 13, 2025
Study Start
April 13, 2025
Primary Completion (Estimated)
December 1, 2035
Study Completion (Estimated)
December 31, 2035
Last Updated
April 15, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share