The Biobank Integrating Longitudinal ERCP Within a Prospective Chronic Pancreatitis Cohort

NCT07770412 | Not Yet Recruiting

• 1 other identifier: HZ-BILE-CP-2026
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Chronic Pancreatitis

Keywords

chronic pancreatitis; Endoscopic Retrograde Cholangiopancreatography; multi-omics; ERCP

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Two years

Secondary Outcomes (27)

• Change in the Morphological Severity of Chronic Pancreatitis

  Six months

• Number of Participants with CT-Detected Morphological Abnormalities or Complications

  Six months

• Number of Participants Requiring Specific ERCP Therapeutic Interventions

  Six months

• Number of Participants with EUS-Detected Pancreatic Microstructural Abnormalities

  Six months

• Change in Traditional Chinese Medicine (TCM) Constitution Scores

  Six months

Study Arms (1)

BILE-CP Cohort: Patients with Chronic Pancreatitis Meeting Inclusion and 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

Interventions

This observational cohort study does not involve any interventions OTHER

This observational cohort study does not involve any interventions

BILE-CP Cohort: Patients with Chronic Pancreatitis Meeting Inclusion and Exclusion Criteria

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First People's Hospital of Hangzhou: lead
• Westlake University: collaborator

Study Sites (1)

First People's Hospital of Hangzhou

Hangzhou, Zhejiang, 310006, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Multi-site biological samples including blood (such as whole blood, serum, and plasma), feces, bile, saliva, tongue coating, and urine will be collected and retained in the biobank for future multi-omics analyses and microbiome evaluations.

MeSH Terms

Conditions

Pancreatitis, Chronic

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Xiaofeng Zhang

CONTACT

86-0571-56005600; zhangxiaofeng@hospital.westlake.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician, Department of Gastroenterology, First People's Hospital of Hangzhou

Study Record Dates

• First Submitted: August 8, 2026
• First Posted: August 18, 2026
• Study Start: August 15, 2026
• Primary Completion (Estimated): January 31, 2031
• Study Completion (Estimated): August 31, 2031
• Last Updated: August 18, 2026

Record last verified: 2026-08

Locations

CN (1)