The Usefulness of Newly Modified Non-flared Fully Covered Metal Stent of 12 mm in diameter Comparing with Conventional Stent for Periampullary Malignant Biliary Strictures

The Usefulness of Newly Modified Non-flared Fully Covered Metal Stent of 12 mm in diameter Comparing with Conventional Stent for Periampullary Malignant Biliary Strictures - M-FCSEMS in periampullary malignant biliary stricture

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000030201

Enrollment

Registered

2017-12-31

Start date

2014-01-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

under IRB

Interventions

ERCP with biliary drainage of newly modified non-flared FCSEMS(BONASTENT M-intraductal 12)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Age at least 18 years 2)Periampullary cancer; ampulla of Vater cancer, distal CBD cancer, pancreatic head cancer 3)Clinical symptoms of biliary obstruction with obstructive jaundice and/or cholangitis

Exclusion criteria

Exclusion criteria: 1)Surgically altered anatomy 2)Bleeding tendency (INR > 1.5 or platelet count < 50,000/mm3) 3)Contraindications for ERCP

Design outcomes

Primary

Measure	Time frame
Stent migration rate in periampullary malignant biliary stricture	—

Secondary

Measure	Time frame
-Technical success rate -Clinical success rate -Other adverse events -Stent occlusion and re-intervention rate -Stent patency	—

Countries

Asia(except Japan)

Contacts

Public ContactHyun Woo Lee

SoonChunHyang University School of Medicine Digestive Disease Center and Research Institute

imlhw@schmc.ac.kr+821080235271

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026