A multicenter prospective study of the incidence of cholecystitis after endoscopic biliary drainage using a novel low axial force covered self-expandable metallic stent in patients with unresectable malignant distal biliary obstruction

A multicenter prospective study of the incidence of cholecystitis after endoscopic biliary drainage using a novel low axial force covered self-expandable metallic stent in patients with unresectable malignant distal biliary obstruction - A multicenter prospective study of the incidence of cholecystitis after EBD using a novel low axial force CSEMS in patients with unresectable malignant distal biliary obstruction

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000038209

Enrollment

100

Registered

2019-11-01

Start date

2019-11-12

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

patients with unresectable malignant distal biliary obstruction

Interventions

Endoscopic biliary drainage using a novel low axial force covered self-expandable metallic stent for malignant distal biliary obstruction.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. age =>20 2. patients with malignant distal biliary obstruction (or stricture) 3. unresectable 4. providing written informed consent

Exclusion criteria

Exclusion criteria: 1. after cholecystectomy 2. patients with malignant hilar biliary obstruction 3. after gastric surgery (excluding B-I method) 4. performance status 4 5. history of metal allergy 6. patients whose participation in the trial was judged to be inappropriate by the investigator

Design outcomes

Primary

Measure	Time frame
incidence of cholecystitis	—

Secondary

Measure	Time frame
technical success rate functional success rate time to recurrent biliary obstruction adverse events	—

Countries

Japan

Contacts

Public ContactNaoki Minato

Kitasato University School of Medicine Department of Gastroenterology

mina0316@kitasato-u.ac.jp81-42-778-8111

Outcome results

None listed

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