A novel metallic stent for unresectable distal malignant biliary obstruction; A multicenter prospective study

A novel metallic stent for unresectable distal malignant biliary obstruction; A multicenter prospective study - EVOLUTION study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000030022

Enrollment

Registered

2017-11-17

Start date

2018-03-16

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 distal malignant biliary obstruction

Interventions

Full covered self expandable metal stent

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Patients with unresectable malignant biliary stricture diagnosed by pathological findings. (2) Patients with written informed consent.

Exclusion criteria

Exclusion criteria: (1) Patients with uncontrolable jaundice or cholangitis after biliary drainage. (2) Patients with serious comorbidities. (3) Patients with ECOG performance status 4. (4) Patients with not expected prognosis more than 3 months. (5) Patients with hilar biliary stricture. (6) Patients with biliary reconstruction. (7) Patients with considered ineligible by the attending physician.

Design outcomes

Primary

Measure	Time frame
Stent patency	—

Secondary

Measure	Time frame
Technical success, Clinical success, Complications, Stent replaced, Survival period	—

Countries

Japan

Contacts

Public ContactArata Sakai

Kobe University Graduate School of Medicine Division of gastroenterology, Department of Internal medicine

asakai@med.kobe-u.ac.jp078-382-6305

Outcome results

None listed

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