Randomized Controlled Trial on Clinical Outcomes of EUS-guided Biliary Drainage vs. Balloon-enteroscopy-assisted ERCP for Malignant Biliary Obstruction

Randomized Controlled Trial on Clinical Outcomes of EUS-guided Biliary Drainage vs. Balloon-enteroscopy-assisted ERCP for Malignant Biliary Obstruction - Red Ball Study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000038316

Enrollment

Registered

2019-10-16

Start date

2019-10-16

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

Biliary obstruction

Interventions

EUS-BD BE-ERCP

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: a. malignant biliary obstruction b. surgically-altered anatomy except Billroth-I reconstruction c. total biliarubin (TB) >/= 2.0 mg/dL d. no previous biliary stenting e. condition applicable for both interventions f. written IC

Exclusion criteria

Exclusion criteria: a. impossibility for endoscopic therapy b. poor general condition, ASA class 4 or poorer. c. extremely poor condition due to malignancy d. condition in which either intervention cannot be applicable e. condition in which either intervention is obviously favorable f. previous EUS-BD, BE-ERCP, ERCP, or percutaneous biliary drainage g. previous registration to this study h. elevated TB level derived from diseases other than biliary obstruction, such as hemolysis i. allergy for a contrast agent j. pregnancy k. impossibility for observation after treatment l. at doctor's discretion

Design outcomes

Primary

Measure	Time frame
Overall procedure time	—

Secondary

Measure	Time frame
Success rate of biliary decompression, adverse events, recurrence of biliary obstruction, number of reintervention, survival period	—

Countries

Japan

Contacts

Public ContactYoshihide Kanno

Sendai City Medical Center Department of Gastroenterology

yoshi-hk@openhp.or.jp022-252-1111

Outcome results

None listed

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