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Comparison of the efficacy of biliary stent with intracavitary irradiation versus External Beam Radiotherapy Combined With Expandable Metallic Stent in treating inoperable Hilar Cholangiocarcinoma: a randomized controled trial

Comparison of the efficacy of biliary stent with intracavitary irradiation versus External Beam Radiotherapy Combined With Expandable Metallic Stent in treating inoperable Hilar Cholangiocarcinoma: a randomized controlled trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000036610
Enrollment
Unknown
Registered
2020-08-24
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-09-21

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

Conditions

hilar Cholangiocarcinoma

Interventions

Group 1:biliary stent with intracavitary irradiation
Group 2:External Beam Radiotherapy Combined With Expandable Metallic Stent

Sponsors

The Third Affiliated Hospital of Naval Military Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged between 18 and 80 years; 2. Biliary obstruction caused by hilar cholangiocinoma; 3. Symptoms such as jaundice related to biliary obstruction; 4. Unresectability or refusal to be surgically treated; 5. The expected overall survival is more than 3 months; 6. Willing and able to comply with the study procedures and provide written informed consent to participate in the study.

Exclusion criteria

Exclusion criteria: 1. Patients with suspected benign bile duct stricture; 2. Biliary tract stricture that could not be dilated enough to pass the delivery system; 3. Perforation of any ducts within the biliary tree; 4. HCC has received chemotherapy, radiotherapy, targeted drugs, PD1 and other anti-tumor therapy; 5. Presence of metallic biliary stent or bile duct surgery; 6. Percutaneous transhepatic cholangiography (PTC) procedure was contraindicated; 7. Active hepatitis orsclerosing cholangitis; 8. Intrahepatic metastases that extensively involves both lobes of the liver; 9. Uncontrolled hepatic encephalopathy, hepatorenal syndrome, ascites; 10. Active bleeding or abnormal coagulation function, has bleeding tendency or is receiving thrombolytic, anticoagulant or antiplatelet therapy; 11. Uncooperative or could not provide authorization and signature; 12. Any reason that researcher does consider its not possible to enroll.

Design outcomes

Primary

MeasureTime frame
overall survival;

Secondary

MeasureTime frame
patency time of stent;

Countries

China

Contacts

Public ContactHuang Jian
huangswords@163.com+86 18217574281

Outcome results

None listed

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