Multi-Hole Self-expandable Metal Stent (MHSEMS) versus Fully-covered Self-Expandable Metal Stent (FCSEMS) for Unresectable Malignant Distal Biliary Obstruction (M-FED Study): A Multi-center Prospective Randomized Controlled Trial Research

Multi-Hole Self-expandable Metal Stent (MHSEMS) versus Fully-covered Self-Expandable Metal Stent (FCSEMS) for Unresectable Malignant Distal Biliary Obstruction (M-FED Study): A Multi-center Prospective Randomized Controlled Trial Research - M-FED Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000034427

Enrollment

Registered

2018-10-10

Start date

2018-03-23

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

Interventions

Inserting Multi-Hole covered Self-expandable Metal Stent(MHSEMS) for the patient who has unresectable malignant distal biliary obstruction.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patient with Unresectable Malignant Distal Biliary Obstruction

Exclusion criteria

Exclusion criteria: 1.Pregnancy 2.Contraindications for ERCP 3.Hilar stricture identified during cholangiogram 4.Failed ERCP 5.Subsequent investigations diagnose benign biliary strictures

Design outcomes

Primary

Measure	Time frame
A migration rate compared with a conventional stent (FCSEMS) of a new stent (MHSEMS)	—

Countries

Japan

Contacts

Public ContactSho Takahashi

Juntendo University School of Medicine Gastroenterology

sho-takahashi@juntendo.ac.jp03-3813-3111

Outcome results

None listed

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