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Prospective Randomized Trial Comparing Metal Stents Placed Aboved the Sphincter of Oddi and Metal Stents Across the Sphincter of Oddi in Malignant Extrahepatic bile duct Obstruction

Prospective Randomized Trial Comparing Metal Stents Placed Aboved the Sphincter of Oddi and Metal Stents Across the Sphincter of Oddi in Malignant Extrahepatic bile duct Obstruction

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-09000513
Enrollment
Unknown
Registered
2009-09-04
Start date
2009-09-01
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

Two groups:Metal Stents Placed Aboved the Sphincter of Oddi and Metal Stents Across the Sphincter of Oddi

Sponsors

Department of gastroenterology of General Hospital of Chinese People's Liberation Army
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. To be with inoperable and/or unresectable malignant extrahepatic bile duct obstruction; 2. Be older than 18 year; 3. To be with bile duct or gallbladder cancer invading CBD or distal CHD; 4. To be with pancreatic cancer with mid or distal CBD invasion; 5. 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; 6. Without liver metastasis; First attempt of endoscopic biliary metallic or plastic stenting; 7. Not experinced biliary tract surgery; 8. Life expectancy at least longer than 4 months (Karnofsky score >60%).

Exclusion criteria

Exclusion criteria: 1. Ampullary cancer; 2. Klatskin tumor; 3. Combined intrahepatic bile duct cancer; 4. 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

MeasureTime frame
Patency of stent;Frequency of cholangitis;

Countries

China

Contacts

Public ContactEnqiang Linghu
lheq128@sina.com+86 13501233558

Outcome results

None listed

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