Randomized controlled trial on efficacy of metal stents vs. inside plastic stents for unresectable malignant obstruction of the perihilar bile duct

Randomized controlled trial on efficacy of metal stents vs. inside plastic stents for unresectable malignant obstruction of the perihilar bile duct - MiPS study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000025760

Enrollment

130

Registered

2017-02-24

Start date

2017-03-01

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 malignant perihilar biliary obstruction

Interventions

Deployment of inside PSs Deployment of metal stents (MSs)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: a. those who have been diagnosed as malignant perihilar biliary obstruction with Bismuth level 2 or more. b. Clinically non resectable c. Total biliarubin =/> 2.0 mg/dL d. No history of previous biliary stent placement e. Expected prognosis > 3 months f. Obtaining written informed concent

Exclusion criteria

Exclusion criteria: a. No tolerance of endoscopic procedures b. ASA class 4 or more c. Reconstructed upper GI tract d. State after papillectomy, surgical biliojejunostomy e. Planned for surgical resection, radiotherapy, PDT, or HIFU f. Planned for scheduled replacement of PSs g. State after placement of irremoval biliary stents h. Tumors extending to lower bile duct i. Tumors which have already invaded to broad area and which was considered to be difficult to treat with biliary drainage j. Tumors with papillary growth k. Active infectious inflammation l. PSC, IgG4-SC and PBC m. LC stage Child-Pugh C n. Hemolyzing disease o. Allergic for contrast

Design outcomes

Primary

Measure	Time frame
Patency period of inside PSs	—

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