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Bile acid profiles in patients with biliary tract neoplasms

Bile acid profiles in patients with biliary tract neoplasms

Status
Active, not recruiting
Phases
Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300068817
Enrollment
Unknown
Registered
2023-03-01
Start date
2023-03-01
Completion date
Unknown
Last updated
2023-05-22

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

Conditions

biliary tract neoplasms

Interventions

the healthy:N/A
people with malignant biliary tract diseases:N/A
people with benign biliary tract diseases:N/A
People undergoing hepatobiliary surgery for non-biliary diseases:N/A

Sponsors

Zhongshan Hospital Affiliated to Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Healthy people 1) The informed consent has been fully understood and signed; 2) Age: 18-80 years old; 3)BMI18.5-24 kg/m2 4) Healthy people (without diabetes, NAFLD, disorder of lipid metabolism, metabolic syndrome, chronic diarrhea, inflammatory bowel disease, metabolic syndrome, irritable bowel syndrome, hepatobiliary and pancreatic diseases) in physical examination within one year; 5) Liver and kidney function, blood glucose, blood lipids, urine and stool routine are within the normal range. 2. People with malignant biliary diseases: 1) The informed consent has been fully understood and signed; 2) Age: 18-80 years old; 3) The diagnosis of malignant disease of biliary tract is clear (confirmed by biopsy and pathology). 3. People with benign biliary diseases: 1) The informed consent has been fully understood and signed; 2) Age: 18-80 years old; 3) The diagnosis of biliary tract disease is clear (Cholelithiasis: oily eating, right upper abdominal pain and other manifestations, imaging diagnosis is clear; cholecystitis: right upper abdominal pain and other manifestations, imaging diagnosis is clear; oddi sphincter dysfunction: repeated attacks of biliary or pancreatic pain, transaminase, direct bilirubin, alkaline phosphatase rise, imaging shows biliary or pancreatic duct dilation and combined with ERCP to eliminate stone tumors and other organic diseases; primary sclerosing cholangitis: ERCP, MRCP It shows multiple strictures of the bile duct, irregular dilation, excluding secondary factors and no malignant change). 4. People undergoing hepatobiliary surgery for non-biliary diseases: 1) The informed consent has been fully understood and signed; 2) Age: 18-80 years old; 3) Liver transplant recipients (primary liver cancer, end-stage cirrhosis, acute and chronic liver failure); 4) Partial resection of liver tissue (liver lesions meet the criteria, such as giant hemangioma, giant cyst, primary hepatocellular carcinoma).

Exclusion criteria

Exclusion criteria: 1) Those with a history of any of the following intestinal diseases: chronic diarrhea, chronic intestinal obstruction, Crohn's disease, ulcerative colitis, familial hereditary polyposis, colorectal cancer, intestinal tuberculosis, intestinal typhoid, gastrointestinal tumors, gastrointestinal surgery to change the normal anatomical structure, etc; 2) Receive antibiotic or probiotics treatment in a short time; 3) Have any of the following liver diseases: viral hepatitis, autoimmune liver disease, alcoholic liver disease, hereditary liver disease; 4) Cholecystectomy has been performed and the structure of biliary tract has changed; 5) Decompensated cirrhosis; 6) HBsAg (+), and/or HCV-Ab (+); 7) Patients with severe kidney disease or serum creatinine = 256umol/L; 8) Patients with other serious diseases (patients with severe heart disease: patients with myocardial infarction and heart failure and/or serious arrhythmia, patients with severe infection: patients with severe trauma, patients with serious damage to other organs within 6 months after surgery (patients with non-biliary diseases undergoing hepatobiliary surgery may have acute liver injury); 9) Male or female patients who are pregnant or may be pregnant and lactating or who wish to be pregnant during the test; 10) Patients who have participated in other clinical trials within 24 weeks; 11) Those who are unable to comply with the research plan due to mental illness; 12) Those who do not sign the informed consent form; 13) Incomplete subject information; 14) Other, the researcher thinks it is not suitable to be the test object;

Design outcomes

Primary

MeasureTime frame
bile acid profiles;

Secondary

MeasureTime frame
Histological changes of liver;

Countries

China

Contacts

Public ContactSuo Tao

Department of General Surgery, Zhongshan Hospital, Fudan University, Shanghai 200032, China

suo.tao@zs-hospital.sh.cn+86 136 8197 1201

Outcome results

None listed

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