Phase I/II study of endoscopic ultrasound-guided choledochoduodenostomy for biliary drainage treatment (using metallic stent)of patients with malignant biliary obstruction

Phase I/II study of endoscopic ultrasound-guided choledochoduodenostomy for biliary drainage treatment (using metallic stent)of patients with malignant biliary obstruction - PhaseI/II study of EUS-guided choledochoduodenostomy for biliary drainage(using metallic stent)

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003635

Enrollment

Registered

2010-05-18

Start date

2010-04-01

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

Malignant biliary obstruction

Interventions

EUS-guided choledochoduodenostomy (EUS-CDS) was approached from the first portion of the duodenum using a convex echoendoscope and a needle knife. Second steps of the procedure are passage dilatation

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Biliary obstruction induced by malignant tumor 2. Non-resectable tumor 3. Major organ preserved 4. Performance status (ECOG) is 0-3

Exclusion criteria

Exclusion criteria: 1. Obstruction of upper GI tract 2. Obstruction of upper part of extrahepatic biliary duct 3. History or schedule of radiotherapy for duodenum 4. Inappropriate for this trial by doctors

Design outcomes

Primary

Measure	Time frame
Grade and incidence of adverse events Rate of successful completion of procedure	—

Secondary

Measure	Time frame
patency period of stent	—

Countries

Japan

Outcome results

None listed

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