The Biobank Integrating Longitudinal ERCP within a Prospective Chronic Pancreatitis Cohort (BILE-CP) is a prospective longitudinal cohort study conducted in Hangzhou, Zhejiang Province, China. The study plans to consecutively enroll 1,500 patients with chronic pancreatitis for long-term follow-up (scheduled every 6 months). This cohort encompasses patients across the entire disease course of chronic pancreatitis, with a particular focus on and in-depth tracking of a sub-cohort of patients undergoing ERCP treatments. During baseline and follow-up visits, researchers will collect multidimensional data from participants, including sociodemographics, diet and lifestyle, emotional status and sleep quality, clinical phenotypes and disease characteristics, ERCP intervention details, clinical laboratory and imaging examinations, continuous glucose monitoring (CGM), and traditional Chinese medicine indicators. Concurrently, multi-site biological samples will be collected, including but not limited to blood, feces, bile, saliva, tongue coating, and urine.
Age ≥ 18 years, with no sex restrictions.
Meets the diagnostic criteria for chronic pancreatitis, with a definitive diagnosis of chronic pancreatitis based on imaging, pathology, or pancreatic function tests;
Receiving medical care at the study center and willing to accept long-term follow-up management.
Able to cooperate with baseline data collection and scheduled follow-ups.
Concomitant malignancies.
Concurrent severe systemic diseases with an expected life expectancy of < 1 year.
History of major pancreatic resection or pancreaticoduodenectomy.
History of major gastrointestinal surgery.
The study population consists of adult patients (aged 18 years and older, regardless of sex) who are clinically diagnosed with chronic pancreatitis and are receiving medical care at the study center (Hangzhou First People's Hospital) in Hangzhou, Zhejiang Province, China.
Cohort
Prospective
This observational cohort study does not involve any interventions
Other interventionThis observational cohort study does not involve any interventions
Changes in Exocrine Functions
Evaluated by scores from the pancreatic exocrine insufficiency questionnaire. The calculated final score ranges from 0 to 4. Higher scores indicate more severe symptoms and worse pancreatic exocrine function.
Incidence of Unplanned Readmissions Related to Chronic Pancreatitis and Its Complications
Evaluated by documenting the number of participants who experience at least one unplanned hospital readmission related to chronic pancreatitis and its complications within the follow-up period.
Incidence of Pancreatic Cancer
Evaluated by documenting the number of participants who develop pancreatic cancer during the follow-up period. The diagnosis is clinically confirmed based on abdominal imaging, specific tumor markers, and/or pathological evaluation.
Change in the Morphological Severity of Chronic Pancreatitis
Evaluated using abdominal MRI/MRCP based on the Cambridge classification system. The Cambridge classification grades the severity of chronic pancreatitis based on features such as ductal dilation, strictures, stones, and parenchymal changes. The structural severity is typically graded as normal, equivocal, mild, moderate, or severe. A worse grade indicates more advanced morphological changes.
Number of Participants with CT-Detected Morphological Abnormalities or Complications
Evaluated by documenting the number of participants who exhibit at least one of the following specific features on abdominal CT: pancreatic parenchymal calcification, solid masses, suspected malignant lesions, peripancreatic exudation or fluid collection, vascular complications, or progression of pancreatic fibrosis.
Number of Participants Requiring Specific ERCP Therapeutic Interventions
Evaluated by documenting the number of participants who undergo one or more specific Endoscopic Retrograde Cholangiopancreatography (ERCP) therapeutic interventions during the follow-up period.
Number of Participants with EUS-Detected Pancreatic Microstructural Abnormalities
Evaluated by documenting the number of participants who exhibit specific microstructural changes in the pancreatic parenchyma and pancreatic ducts using Endoscopic Ultrasound (EUS).
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First People's Hospital of Hangzhou
Lead sponsor
Westlake University
Collaborator
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