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Diagnosis, surgical complications and prognosis of cholangiocarcinoma based on bile microbiome and metabolomics: a multicenter prospective cohort study

Diagnosis, surgical complications and prognosis of cholangiocarcinoma based on bile microbiome and metabolomics: a multicenter prospective cohort study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500096710
Enrollment
Unknown
Registered
2025-02-05
Start date
2025-02-15
Completion date
Unknown
Last updated
2025-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholangiocarcinoma

Interventions

Benign biliary disease group:None

Sponsors

Peking Union Medical College Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Cholangiocarcinoma group: (1) Age of 18-90 years old; (2) The patient had obstructive jaundice (jaundice of the skin, sclera, dark yellow urine, etc.) and serum total bilirubin >100(µmol/L) on admission; (3) cholangiocarcinoma (confirmed as malignant by postoperative pathological examination); (4) Preoperative biliary drainage was performed in the included hospitals; (5) Radical surgery was performed for the first time at the hospitals included in the study. Benign biliary disease group: (1) Age of 18-90 years old; (2) diagnosis of cholecystolithiasis, choledocholithiasis or benign biliary stricture with abdominal imaging evidence, including abdominal ultrasound, CT or magnetic resonance imaging; (3) patients underwent cholecystectomy, bile duct exploration or choledochojejunostomy for the first time at the included hospital.

Exclusion criteria

Exclusion criteria: Cholangiocarcinoma group: (1) patients with surgical contraindications or unable to accept radical surgery for various reasons; (2) use of antibiotics within 1 month before bile collection; (3) incomplete medical records; (4) the presence of diabetes mellitus, metabolic syndrome or serious systemic chronic diseases. Benign biliary disease group: (1) patients with surgical contraindications or unable to receive surgical treatment for various reasons; (2) patients who received antibiotics within 1 month before surgery; (3) incomplete medical records; (4) the presence of diabetes mellitus, metabolic syndrome or serious systemic chronic diseases.

Design outcomes

Primary

MeasureTime frame
Bile microbiome and metabolomics;

Secondary

MeasureTime frame
Postoperative Complications;Recurrence-free survival and overall survival;

Countries

China

Contacts

Public ContactHaitao Zhao

Peking Union Medical College Hospital

zhaoht@pumch.cn+86 139 0124 6374

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026