Host-Microbe Interactions in Biliary Dilatation

NCT07152496 | Not Yet Recruiting

• 1 other identifier: 24756-0-01
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

This study is an observational cohort study aimed at continuously enrolling patients with biliary dilatation and healthy controls. It will collect bile duct tissue samples and clinical data from participants across all age groups to establish a comprehensive cohort for biliary dilatation research. Based on this cohort, the study seeks to investigate the molecular mechanisms underlying biliary dilatation development and progression, explore the role of host-microbiome interactions in disease processes, and identify biomarkers associated with complications and malignancy risk, to establish evidence-based strategies for improved diagnosis and treatment of biliary dilatation.

Conditions

Choledochal Cyst

Keywords

molecular mechanism; Biliary Dilatation; microbiome

Outcome Measures

Primary Outcomes (1)

• molecular mechanisms

  Identification of differentially expressed genes and altered molecular pathways in biliary dilatation through integrated transcriptome analysis of bile duct tissue samples, measured by RNA sequencing and bioinformatics analysis.

  At the time of surgery.

Study Arms (2)

This group included BD patients

This group included healthy control

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Disease Group: Patients diagnosed with biliary dilatation who are scheduled for surgical resection. These participants represent the primary study population for investigating the molecular mechanisms and microbiome characteristics associated with biliary dilatation. Control Group: Healthy donor bile duct tissues that are routinely discarded during organ transplantation surgical procedures. These tissues represent normal bile duct samples that are removed as part of standard surgical preparation but are not used for transplantation, serving as healthy controls for comparison of transcriptome and microbiome profiles.

You may qualify if:

• Patients who have been definitively diagnosed with biliary dilatation and are scheduled for surgical resection (Disease group) Healthy donor bile duct tissues discarded during organ transplantation procedures as part of routine surgical preparation (Control group)

You may not qualify if:

• Patients with severe systemic diseases that may affect study outcomes (Disease group) Insufficient tissue sample quality or quantity (Disease group) Unavailable or inadequate donor bile duct tissue samples (Control group)

Sponsors & Collaborators

• Beijing Tsinghua Chang Gung Hospital: lead

Study Sites (1)

Beijing Tsinghua Changgung Hospital

Beijing, Beijing Municipality, 102218, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

bile duct tissue

MeSH Terms

Conditions

Choledochal Cyst

Condition Hierarchy (Ancestors)

Cysts; Neoplasms; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Digestive System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Shuo Jin, Principal Investigator

  Beijing Tsinghua Changgeng Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Siqiao Shan

CONTACT

+86 13683156996; dsqs01567@btch.edu.cn

Shuo Jin

CONTACT

jsa01263@btch.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 3, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 9, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)