Plastic stent placement above the sphincter of Oddi ("inside-stent") for patients of malignant hilar biliary obstruction. A prospective phase II trial.

Plastic stent placement above the sphincter of Oddi ("inside-stent") for patients of malignant hilar biliary obstruction. A prospective phase II trial. - Plastic stent placement above the sphincter of Oddi ("inside-stent") for patients of malignant hilar biliary obstruction.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006779

Enrollment

Registered

2011-12-01

Start date

2011-12-01

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

Malignant hilar biliary obstruction

Interventions

A plastic stent which is attached a nylon string is used. The plastic stent is placed endoscopically above the sphincter of Oddi for malignant hilar biliary obstruction.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Unresectable malignant hilar biliary obstruction is proven by pathological or radiological diagnosis. 2.A stent placement is needed. 3.The therapy of a stent placement have never been performed. 4.Endoscopic stenting can be performed. 5.A stent can be placed above the sphincter of Oddi. 6.Written informed concent of the print.

Exclusion criteria

Exclusion criteria: 1.The prognosis is considered within 3 months. 2.They have jaundice which can't be improved by stenting. For example, liver failure. 3.Decision of unsuitableness by principal investigator.

Design outcomes

Primary

Measure	Time frame
Time to dysfunction	—

Secondary

Measure	Time frame
1.Dysfunction rate and substance 2.Complication rate and substance 3.Suvival time 4.Re-intervention rate and method 5.Operation time 6.success rate of operation	—

Countries

Japan

Contacts

Public ContactTomohiro Ishii

Yokohama City University Medical Center Gastroenterological Center

tishii@yokohama-cu.ac.jp045-261-5656

Outcome results

None listed

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

Plastic stent placement above the sphincter of Oddi (&quot;inside-stent&quot;) for patients of malignant hilar biliary obstruction. A prospective phase II trial.