A prospective study of metal stent placement for unresectable malignant distal biliary obstruction

A prospective study of fully covered self-expandable metal stent placement for unresectable malignant distal biliary obstruction to find the optimal stent - A prospective study of fully covered self-expandable metal stent placement for unresectable malignant distal biliary obstruction to find the optimal stent

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000055977

Enrollment

Registered

2024-10-29

Start date

2024-11-01

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 biliary obstruction due to pancreatobiliary cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients who underwent transpapillary placement of a 10 mm FCSEMS for malignant distal biliary obstruction due to pancreatobiliary cancer 2) Patients scheduled to undergo non-resection 3) Patients whose life prognosis are expected more than 3 months

Exclusion criteria

Exclusion criteria: 1) Patients with postoperative reconstruction of the upper gastrointestinal tract 2) Patients after bilioenteric anastomosis 3) Patients in whom clinical success is not expected by stent placement 4) Patients with a history of biliary drainage using metal stent 5) Pregnant patients 6) Patients who ultimately underwent surgical resection for the malignant distal biliary obstruction

Design outcomes

Primary

Measure	Time frame
time to recurrent biliary obstruction	—

Secondary

Measure	Time frame
Causes of recurrence of biliary obstruction (RBO) Technical success rate Clinical success rate Rate of early adverse events Rate of late adverse events other than RBO Survival period Technical success rate of reintervention in cases of RBO	—

Countries

Japan

Contacts

Public ContactToji Murabayashi

Ise Red Cross Hospital Department of Gastroenterology

t-murabayashi@ise.jrc.or.jp0596-28-2171

Outcome results