The role of anti-reflux biliary stent in patients with unresectable non-hilar malignant biliary obstruction: a prospective randomized study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-11001800

Enrollment

Unknown

Registered

2011-12-15

Start date

2009-01-01

Completion date

Unknown

Last updated

2017-04-18

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

Conditions

unresectable non-hilar malignant biliary obstruction

Interventions

Control group:Ordinary metal stent was implanted

anti-reflux biliary stent group:Anti-reflux biliary stent was implanted

Eligibility

Sex/Gender

All

Age

20 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Unresectable non-hilar malignant biliary obstruction was confirmed by pathology or US, CT and/or MRI, or not a candidate for curative surgical resection due to operative risk or patient wishes; 2. Patients is 20 to 80 years of age; 3. Total Bilirubin>34.2umol/L (normal<17.1umol/L); 4. Information given and informed consent obtained.

Exclusion criteria

Exclusion criteria: 1. Non-obstructive jaundice; 2. Hilar malignant biliary obstruction; 3. Total Bilirubin<=34.2umol/L (normal<17.1umol/L); 4. Resectable non-hilar malignant biliary obstruction; 5. Benign distal common bile duct obstruction; 6. Previous stenting; 7. Previous bile duct surgery; 8. Informed consent not obtained; 9. ERCP contraindication.

Design outcomes

Primary

Measure	Time frame
Stent patency;Survival of patient;	—

Secondary

Measure	Time frame
Serum bilirubin;Unexplained fever;Technical Success of stent placement;	—

Countries

China

Contacts

Public ContactHu Bing

drhubing@yahoo.cn+86 21 81875221

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 8, 2026