The feasibility of the new designed biliary metallic stent with distal tapering shape for the unresectable distal biliary malignancies: A pilot study

The feasibility of the new designed biliary metallic stent with distal tapering shape for the unresectable distal biliary malignancies: A pilot study - BULLET trial

Status

Recruiting

Phases

Phase 2

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000042078

Enrollment

Registered

2020-10-11

Start date

2017-12-01

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

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Unresectable distal biliary malignant obstruction (regardless of primary disease) 2) Never received treatment with SEMS 3) Cases with expected prognosis of more than 2 months 4) 20 years or older 5) Cases with informed consent after sufficient explanation from physician and patient's understanding 6) 2 or less in ECOG performance status

Exclusion criteria

Exclusion criteria: 1) Massive ascites 2) Cases with serious complications in other organs 3) Hilar biliary obstruction 4) Altered anatomy following Billroth-II or Roux-en-Y gastrectomy 5) Case in which ERCP is difficult to perform 6) Duodenal stenosis on the anal side more than the duodenal papilla (cases improved with the duodenal stent can be enrolled) 7) Case in which the physician judged inappropriate for some reason

Design outcomes

Primary

Measure	Time frame
Stent malfunction and obstruction rate Stent patency period	—

Secondary

Measure	Time frame
Median survival period The incidence of adverse event	—

Countries

Japan

Contacts

Public ContactShinpei Shinpei

Teikyo University School of medicine University Mizonokuchi Hospital Dept of Gastroenterology

sinpesan@gmail.com044-844-3333

Outcome results