Randomized controlled trial of endoscopic biliary drainage in patients with unresectable malignant distal biliary obstruction: transpapillary route vs. transenteric route

Randomized controlled trial of endoscopic biliary drainage in patients with unresectable malignant distal biliary obstruction: transpapillary route vs. transenteric route - Randomized controlled trial of endoscopic biliary drainage in patients with unresectable malignant distal biliary obstruction: transpapillary route vs. transenteric route

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000017065

Enrollment

100

Registered

2015-04-08

Start date

2015-03-04

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 malignant distal biliary obstruction

Interventions

Transenteric biliary drainage

TEBD Transpapillary biliary drainage

TPBD

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Malignant tumor with no indication of surgical operation 2) Necessity of biliary draianage 3) Written, signed consent for trial participation must be obtained from the patient or proxies.

Exclusion criteria

Exclusion criteria: 1) Obstruction of intrahepatic bile duct 2) Difficulty of endoscopic procedure 3) Severe complications in other organs 4) Other problem(s) in the opinion of the Investigator(s).

Design outcomes

Primary

Measure	Time frame
technical success rate, clinical success rate, complications	—

Secondary

Measure	Time frame
stent patency	—

Countries

Japan

Contacts

Public ContactTakeshi Hisa

Saku Central Hospital Advanced Care Center Gastrointestinal medicine

ctroffice@sakuhp.or.jp0267-62-8181

Outcome results

None listed

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