Efficacy and safety of endoscopic biliary stenting with fully covered self expandable metal stent for unresectable hilar malignant biliary obstruction: A prospective multicenter study

Efficacy and safety of endoscopic biliary stenting with fully covered self expandable metal stent for unresectable hilar malignant biliary obstruction: A prospective multicenter study - Efficacy and safety of endoscopic biliary stenting with fully covered self expandable metal stent for unresectable hilar malignant biliary obstruction : A prospective multicenter study(FCAP)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000027353

Enrollment

Registered

2017-05-16

Start date

2017-05-16

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

Unresectable hilar malignant biliary obstruction

Interventions

Placement of fully covered self expanding metal stent for unresectable hilar malignant biliary obstruction

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: a) Unresectable hilar malignant biliary obstruction is proven by historical or pathological or radiological diagnosis b) Obstruction of Bismuth type II or higher and before biliary drainage with metal stent c) Effective biliary drainage already performed without metal stent d) Patients of age>=20years e) Life expectancy>=3months f) Patients with written informed consent

Exclusion criteria

Exclusion criteria: a) Patients after gastrectomy without Billroth-I reconstruction b) Patients with pancreatitis c) Inappropriate patients for entry on this study in the judgement of the investigator d) Patients who refused to entry this study

Design outcomes

Primary

Measure	Time frame
Six month primary patency rate of fully covered self-expandable metal stent	—

Secondary

Measure	Time frame
safety, technical success rate, functional success rate, procedure time, stent patency period, cause of stent obstruction, death related endoscopic procedure, re-intervention rate, technical success rate of re-intervention, overall survival time	—

Countries

Japan

Contacts

Public ContactYosuke/ Hirotsugu Kinoshita/ Maruyama

Osaka City University Graduate School of Medicine, Department of Gastroenterology Gastroenterology

yousukekino.13@gmail.com06-6645-3811

Outcome results

None listed

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