A randomized controlled trial to compare antireflux metal stent and conventional covered metal stent for nonresectable distal malignant biliary obstruction

A randomized controlled trial to compare antireflux metal stent and conventional covered metal stent for nonresectable distal malignant biliary obstruction - ARMS as the initial SEMS

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000014784

Enrollment

104

Registered

2014-08-15

Start date

2014-08-20

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

Nonresectable distal malignant biliary obstruction

Interventions

Endoscopic placement of antireflux metal stent for biliay obstruction Endoscopic placement of conventional covered metal stent for biliay obstruction

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. nonresectable malignant biliary obstruction 2. distal biliary obstruction (2 cm or longer from the bifurcation) 3. Without a history of biliary SEMS placement 4. Irrespective of sex and a primary disease 5. Written informed consent obtained

Exclusion criteria

Exclusion criteria: 1. Endoscopic approach to the biliary system is impossible 2. Hilar biliary obstruction 3. Performance status is four 4. Gastrointestinal obstruction distal to the papilla (patients whose gastrointestinal obstruction was resolved via a stent or surgical bypass can be included) 5. Severe comobidities in other organs 6. Pregnant women or those suspected of pregnancy 7. Written informed consent not obtained 8. Patients considered ineligible by attending physicians

Design outcomes

Primary

Measure	Time frame
Time to recurrent biliary obstrution after the placement of metal stent	—

Countries

Japan

Contacts

Public ContactHiroyuki Isayama

Graduate School of Medicine, The University of Tokyo Department of Gastroenterology,

isayama-tky@umin.ac.jp+81-3-3815-5411

Outcome results

None listed

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