An observational study in Chronic Pancreatitis, sponsored by First People's Hospital of Hangzhou. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by First People's Hospital of Hangzhou · Observational
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.
Researchers will recruit participants with chronic pancreatitis, with a specific focus on the sub-population undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP) interventions. This study aims to construct a prospective longitudinal database that integrates sociodemographics, lifestyle factors, emotional status and sleep quality, clinical phenotypes and disease characteristics, ERCP intervention details, laboratory and imaging examinations, traditional Chinese medicine applications, and multi-site biological samples (including blood, feces, bile, saliva, tongue coating, and urine). The primary objective is to clarify the impact of lifestyle and clinical interventions on the disease progression and stage-specific prognosis of chronic pancreatitis. Concurrently, relying on long-term patient follow-up and repeated biological sample collection, the study will systematically investigate the dynamic evolutionary patterns and underlying mechanisms of the multi-site microbiome during disease progression. By integrating patients' multidimensional information and multi-site multi-omics profiles, the research aims to explore precision management models and key biological mechanisms underlying chronic pancreatitis progression and post-ERCP prognosis. Ultimately, this study expect to provide robust scientific evidence for individualized, precise prevention and clinical decision-making in the management of chronic pancreatitis.
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.
Exclusion Criteria:
All eligible patients clinically diagnosed with chronic pancreatitis and receiving standard clinical treatment at the research center. This observational cohort study excludes interventions. And the primary clinical exposure factors of interest include ERCP, lifestyle, and the use of traditional Chinese medicine and herbal remedies.
Other: This observational cohort study does not involve any interventions
This 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.
Time frame: Six months
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.
Time frame: Six months
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.
Time frame: Two years
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.
Time frame: Six months
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.
Time frame: Six months
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.
Time frame: Six months
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).
Time frame: Six months
Change in Traditional Chinese Medicine (TCM) Constitution Scores
Evaluated using a standardized digital TCM instrument, which quantitatively analyzes clinical data to generate scores for 9 standard TCM constitutions. Each of the 9 constitutions is scored on a scale ranging from 0 to 100. Higher scores indicate a stronger inclination toward that specific constitution type.
Time frame: Six months
Number of Participants with Clinically Significant Abnormalities in Blood Biochemistry
Evaluated by documenting the number of participants who exhibit clinically significant abnormal values in routine blood biochemistry tests during the follow-up period. The comprehensive monitoring panel includes liver and kidney function, electrolytes, bilirubin, blood lipids, inflammatory markers, and pancreatic enzymes.
Time frame: Six months
Change in Sleep Quality Score
Description: Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). The total score ranges from 0 to 21. Higher scores indicate worse sleep quality and more severe sleep disturbances.
Time frame: Six months
Continuous Glucose Monitoring
A continuous glucose monitoring system is used to assess glucose fluctuations within the target range.
Time frame: Two weeks
Change in Gastrointestinal Symptom Rating Scale (GSRS) Score
Gastrointestinal Symptom Rating Scale (GSRS) is used to Core assess the symptoms associated with chronic pancreatitis. The GSRS total score ranges from 15 to 105. Higher scores indicate more severe gastrointestinal symptoms
Time frame: Six months
Change in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Index Score
Quality of life will be assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire. The index score typically ranges from less than 0 to 1. Higher scores indicate a better health-related quality of life.
Time frame: Six months
Change in GAD-7 Score
Patients' anxiety levels will be assessed using the Generalized Anxiety Disorder 7-item (GAD-7) scale. The total score ranges from 0 to 21. Higher scores indicate more severe symptoms of anxiety.
Time frame: Six months
Acute Exacerbations of Chronic Pancreatitis
Record the frequency, duration, severity, and treatment outcomes of the patient's acute exacerbations.
Time frame: Six months
Complications Within 30 Days After ERCP
Assess the incidence of adverse events, such as postoperative pancreatitis, biliary tract infection, gastrointestinal bleeding, and perforation occurring within 30 days after ERCP.
Time frame: One month
Change in Relative Abundance of Key Microbial and Fungal Taxa
Evaluated by analyzing microbiome and specific fungal culture data from samples. The outcome measures the quantitative shift in the relative abundance of targeted microbiota communities.
Time frame: Six months
Change in Glycosylated Hemoglobin (HbA1c) Percentage
Pancreatic endocrine function will be evaluated by measuring the percentage of HbA1c in the blood. Higher values indicate poorer long-term glycemic control.
Time frame: Six months
Change in Fasting Blood Glucose Concentration
Endocrine function will be evaluated by assessing fasting blood glucose levels. Higher values indicate impaired glucose metabolism or insulin resistance.
Time frame: Six months
Change in Fasting Serum Insulin Concentration
Endocrine function will be evaluated by measuring fasting serum insulin levels. Abnormal levels can indicate insulin resistance or impaired pancreatic beta-cell function.
Time frame: Six months
Change in Serum C-peptide Concentration
Endocrine function will be evaluated by assessing serum C-peptide levels. C-peptide serves as a reliable biomarker for endogenous insulin production, with lower values indicating decreased pancreatic beta-cell secretory function.
Time frame: Six months
Change in Serum Glucagon Concentration
Endocrine function will be evaluated by measuring serum glucagon levels, a hormone produced by pancreatic alpha cells. Abnormal levels reflect dysregulation in glucose counter-regulation.
Time frame: Six months
Change in Serum Somatostatin Concentration
Endocrine function will be evaluated by measuring serum somatostatin levels, a hormone produced by pancreatic delta cells that regulates the broader endocrine and digestive systems.
Time frame: Six months
Change in Fecal Elastase-1 Concentration
Pancreatic exocrine function will be evaluated by assessing fecal elastase-1 levels. Concentrations below 200 µg/g typically indicate pancreatic exocrine insufficiency (PEI), with lower values reflecting more severe insufficiency.
Time frame: Six months
Change in Serum Fat-Soluble Vitamin Concentrations
Pancreatic exocrine function and secondary nutritional status will be evaluated by measuring the serum concentrations of fat-soluble vitamins (e.g., Vitamins A, D, E, and K). Lower values indicate potential fat malabsorption due to exocrine insufficiency.
Time frame: Six months
Medical Costs Associated with Unplanned Readmissions
Evaluated by calculating the total direct medical costs incurred by participants due to unplanned hospital readmissions related to chronic pancreatitis.
Time frame: Six months
Number of Participants Requiring Surgical or Interventional Procedures During Readmission
Evaluated by documenting the number of participants who require surgical, endoscopic, or other interventional treatments during their unplanned readmission for chronic pancreatitis.
Time frame: Six months
Change in PHQ-9 Score
Patients' depression levels will be assessed using the Patient Health Questionnaire-9 (PHQ-9). The total score ranges from 0 to 27. Higher scores indicate more severe symptoms of depression.
Time frame: Six months
Change in Concentration of Candidate Metabolites
Evaluated using metabolomics profiling to measure the shift in the concentration of specific metabolite biomarkers.
Time frame: Six months
Disease-Associated Multi-Omics Risk Score
Evaluated by integrating high-dimensional multi-omics data derived from multiple biological samples. Advanced statistical modeling, such as LASSO regression and multivariable Cox proportional hazards models, will be applied to construct a composite multi-omics risk signature associated with chronic pancreatitis. The outcome is reported as a continuous multi-omics risk score. Higher scores indicate a greater risk of disease progression and worse clinical outcomes.
Time frame: Six months
Plan to share: Undecided
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First People's Hospital of Hangzhou