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Not Yet Recruiting NCT07770412

The Biobank Integrating Longitudinal ERCP Within a Prospective Chronic Pancreatitis Cohort

Conditions: Chronic Pancreatitis

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 1500
Sponsor: First People's Hospital of Hangzhou

Location: First People's Hospital of Hangzhou Hangzhou Zhejiang

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.

Eligibility Criteria

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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07770412). StuddyBuddy aggregates publicly available trial information.