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Chronic PancreatitisBILE-CPNCT07770412

The Biobank Integrating Longitudinal ERCP Within a Prospective Chronic Pancreatitis Cohort

An observational study of Chronic Pancreatitis, run by First People's Hospital of Hangzhou at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Pancreatitis
What is being tested?
This observational cohort study does not involve any interventions
How many people
1,500 participants
Where
1 siteChina
Study dates
15 Aug 2026to 31 Aug 2031
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site
  • First People's Hospital of Hangzhou

    Hangzhou, Zhejiang, 310006

    Xiaofeng Zhang, 86-0571-56005600, zhangxiaofeng@hospital.westlake.edu.cn

    Zhijie Wang, PhD, 86-0571-56005600, wangzhijie0708@163.com

Other trials in China

About this study

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.

Read the detailed description

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.

Being tested
This observational cohort study does not involve any interventions
Keywords
chronic pancreatitis, Endoscopic Retrograde Cholangiopancreatography, multi-omics, ERCP
Medical subject headings
Pancreatitis, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • This observational cohort study does not involve any interventionsOther

    This observational cohort study does not involve any interventions

Study groups in NCT07770412
Study groupRoleWhat they receive
BILE-CP Cohort: Patients with Chronic Pancreatitis Meeting Inclusion and Exclusion CriteriaAll 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.
Receives: Other: This observational cohort study does not involve any interventions

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Six months

  2. 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.

    Measured: Six months

  3. 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.

    Measured: Two years

Secondary outcomes (27)
  1. 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.

    Measured: Six months

  2. 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.

    Measured: Six months

  3. 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.

    Measured: Six months

  4. 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).

    Measured: Six months

  5. 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.

    Measured: Six months

  6. 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.

    Measured: Six months

  7. 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.

    Measured: Six months

  8. Continuous Glucose Monitoring

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

    Measured: Two weeks

  9. 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

    Measured: Six months

  10. 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.

    Measured: Six months

  11. 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.

    Measured: Six months

  12. Acute Exacerbations of Chronic Pancreatitis

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

    Measured: Six months

  13. 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.

    Measured: One month

  14. 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.

    Measured: Six months

  15. 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.

    Measured: Six months

  16. 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.

    Measured: Six months

  17. 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.

    Measured: Six months

  18. 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.

    Measured: Six months

  19. 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.

    Measured: Six months

  20. 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.

    Measured: Six months

  21. 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.

    Measured: Six months

  22. 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.

    Measured: Six months

  23. 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.

    Measured: Six months

  24. 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.

    Measured: Six months

  25. 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.

    Measured: Six months

  26. Change in Concentration of Candidate Metabolites

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

    Measured: Six months

  27. 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.

    Measured: Six months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2026
  2. Study start15 Aug 2026 (estimated)
  3. Primary completion31 Jan 2031 (estimated)
  4. Study completion31 Aug 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07770412
Sponsor's protocol ID
HZ-BILE-CP-2026
Acronym
BILE-CP
Status last verified
Aug 2026
First submitted
8 Aug 2026
Last updated
18 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Pancreatitis, run by First People's Hospital of Hangzhou at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xiaofeng Zhang (86-0571-56005600, zhangxiaofeng@hospital.westlake.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Exocrine Functions (time frame: Six months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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