The efficacy and safety of inner coated ComVi stent for management of distal malignant biliary obstruction

The efficacy and safety of inner coated ComVi stent for management of distal malignant biliary obstruction - Inner coated ComVi stent for distal malignant biliary obstruction

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004405

Enrollment

Registered

2010-10-25

Start date

2010-10-01

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

Cases of distal malignant biliary obstruction

Interventions

Placement of inner coated ComVi stent for the cases of distal malignant biliary obstruction

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)The Case of distal malignant biliary obstruction 2)The level of total bilirubin is more than 3mg/dl. 3)The expected life expectancy for the patients is more than two months. 4)Written informed consent is obtained. 5)Activity of the case is considered as 0 to 2 by ECOG performance status score.

Exclusion criteria

Exclusion criteria: 1) Ascites 2) Severe coexisting illness 3) Inaccessible to duodenal papilla due to post surgical status 4) Difficult cannulation to duodenal papilla 5) Intestinal or colonic obstruction

Design outcomes

Primary

Measure	Time frame
Patency of Inner coated ComVi stent	—

Secondary

Measure	Time frame
Compliation Median survival period of cases	—

Countries

Japan

Contacts

Public ContactNatsuyo Yamamoto

The University of Tokyo Department of Gastroenterology

natsuyo@tke.att.ne.jp03-3815-5411ext.33070

Outcome results

None listed

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