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NCT Number: NCT07770412

The Biobank Integrating Longitudinal ERCP Within a Prospective Chronic Pancreatitis Cohort

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Provided written informed consent.

Exclusion criteria

  • 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.
  • Pregnant or lactating population.
  • Severe psychiatric disorders, cognitive dysfunction, or assessed by the investigator as having extremely poor compliance, rendering the participant unable to complete the scheduled follow-up plan.
  • Other relevant conditions deemed by the investigator as potentially affecting the study results or compromising participant safety.

Treatment and study plan

This observational cohort study does not involve any interventions

Other

This observational cohort study does not involve any interventions

Primary outcomes

  1. Changes in Exocrine Functions

    Time frame: Six months

    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.

  2. Incidence of Unplanned Readmissions Related to Chronic Pancreatitis and Its Complications

    Time frame: Six months

    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.

  3. Incidence of Pancreatic Cancer

    Time frame: Two years

    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.

Secondary outcomes

  1. Change in the Morphological Severity of Chronic Pancreatitis

    Time frame: Six months

    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.

  2. Number of Participants with CT-Detected Morphological Abnormalities or Complications

    Time frame: Six months

    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.

  3. Number of Participants Requiring Specific ERCP Therapeutic Interventions

    Time frame: Six months

    Evaluated by documenting the number of participants who undergo one or more specific Endoscopic Retrograde Cholangiopancreatography (ERCP) therapeutic interventions during the follow-up period.

  4. Number of Participants with EUS-Detected Pancreatic Microstructural Abnormalities

    Time frame: Six months

    Evaluated by documenting the number of participants who exhibit specific microstructural changes in the pancreatic parenchyma and pancreatic ducts using Endoscopic Ultrasound (EUS).

  5. Change in Traditional Chinese Medicine (TCM) Constitution Scores

    Time frame: Six months

    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.

  6. Number of Participants with Clinically Significant Abnormalities in Blood Biochemistry

    Time frame: Six months

    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.

  7. Change in Sleep Quality Score

    Time frame: Six months

    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.

  8. Continuous Glucose Monitoring

    Time frame: Two weeks

    A continuous glucose monitoring system is used to assess glucose fluctuations within the target range.

  9. Change in Gastrointestinal Symptom Rating Scale (GSRS) Score

    Time frame: Six months

    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

  10. Change in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Index Score

    Time frame: Six months

    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.

  11. Change in GAD-7 Score

    Time frame: Six months

    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.

  12. Acute Exacerbations of Chronic Pancreatitis

    Time frame: Six months

    Record the frequency, duration, severity, and treatment outcomes of the patient's acute exacerbations.

  13. Complications Within 30 Days After ERCP

    Time frame: One month

    Assess the incidence of adverse events, such as postoperative pancreatitis, biliary tract infection, gastrointestinal bleeding, and perforation occurring within 30 days after ERCP.

  14. Change in Relative Abundance of Key Microbial and Fungal Taxa

    Time frame: Six months

    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.

  15. Change in Glycosylated Hemoglobin (HbA1c) Percentage

    Time frame: Six months

    Pancreatic endocrine function will be evaluated by measuring the percentage of HbA1c in the blood. Higher values indicate poorer long-term glycemic control.

  16. Change in Fasting Blood Glucose Concentration

    Time frame: Six months

    Endocrine function will be evaluated by assessing fasting blood glucose levels. Higher values indicate impaired glucose metabolism or insulin resistance.

  17. Change in Fasting Serum Insulin Concentration

    Time frame: Six months

    Endocrine function will be evaluated by measuring fasting serum insulin levels. Abnormal levels can indicate insulin resistance or impaired pancreatic beta-cell function.

  18. Change in Serum C-peptide Concentration

    Time frame: Six months

    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.

  19. Change in Serum Glucagon Concentration

    Time frame: Six months

    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.

  20. Change in Serum Somatostatin Concentration

    Time frame: Six months

    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.

  21. Change in Fecal Elastase-1 Concentration

    Time frame: Six months

    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.

  22. Change in Serum Fat-Soluble Vitamin Concentrations

    Time frame: Six months

    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.

  23. Medical Costs Associated with Unplanned Readmissions

    Time frame: Six months

    Evaluated by calculating the total direct medical costs incurred by participants due to unplanned hospital readmissions related to chronic pancreatitis.

  24. Number of Participants Requiring Surgical or Interventional Procedures During Readmission

    Time frame: Six months

    Evaluated by documenting the number of participants who require surgical, endoscopic, or other interventional treatments during their unplanned readmission for chronic pancreatitis.

  25. Change in PHQ-9 Score

    Time frame: Six months

    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.

  26. Change in Concentration of Candidate Metabolites

    Time frame: Six months

    Evaluated using metabolomics profiling to measure the shift in the concentration of specific metabolite biomarkers.

  27. Disease-Associated Multi-Omics Risk Score

    Time frame: Six months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaofeng Zhang

CONTACT

[email protected]

86-0571-56005600

Sponsors and collaborators

Lead sponsor

First People's Hospital of Hangzhou

Other

Collaborators

  • Westlake University

Registry information

Acronym: BILE-CP

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
Aug 18, 2026
Registry last updated
Aug 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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