Prospective Randomized Trial Comparing Metal Stents Placed and Plastic stent in Malignant Extrahepatic Bile Duct Obstruction

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-09000381

Enrollment

Unknown

Registered

2009-04-15

Start date

2008-01-01

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

Malignant Extrahepatic Bile Duct Obstruction

Interventions

Group B:Plastic sten, inserted across SO

Group A:Metal Stents, inserted above SO

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: To be with inoperable and/or unresectable malignant extrahepatic bile duct obstruction; be older than 18 year; To be with bile duct or gallbladder cancer invading CBD or distal CHD; To be with pancreatic cancer with mid or distal CBD invasion; The cancer should be 2 cm apart from bifurcation and 2 cm apart from ampulla of Vater or Gastrointestinal cancer with hilar lymph node metastasis; Without liver metastasis; First attempt of endoscopic biliary metallic or plastic stenting; Not experinced biliary tract surgery; Life expectancy at least longer than 4 months (Karnofsky score >60).

Exclusion criteria

Exclusion criteria: Ampullary cancer; Klatskin tumor; Combined intrahepatic bile duct cancer; Patient with hemobilia; history of biliary drainage (endoscopic, percutaneous, surgical) except plastic stent or endoscopic nasobiliary drainage smaller than 7 Fr within 5 day.

Design outcomes

Primary

Measure	Time frame
Survival;	—

Secondary

Measure	Time frame
patency of stent;frequency of cholangitis;	—

Countries

China

Contacts

Public ContactLINGHU En-qiang

lheq128@sina.com+86 010 66936998

Outcome results

None listed

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