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Large cell D-type stents for patients with inoperable malignant hilar biliary obstruction

A prospective multicenter study to evaluate the efficacy and safety of a self-expandable large cell metallic stent (Niti-S LCD type) in patients with malignant hilar biliary obstruction

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0002198
Enrollment
40
Registered
2017-01-23
Start date
2013-03-19
Completion date
Unknown
Last updated
2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : After the placement of 2 guidewires into the targeted bilateral intrahepatic branches across the hilar stricture, CO2 cholangiography was performed after injecting 10 to 20 cc of CO2.

Sponsors

Ajou University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) > 20 years of age, (2) malignant hilar biliary obstruction of Bismuth type II or higher, caused by cholangiocarcinoma or gallbladder cancer (3) unsuitable for curative resection due to locally advanced stage, metastasis, or high surgical risk.

Exclusion criteria

Exclusion criteria: a history of prior stent placement or biliary surgery, except cholecystectomy and liver atrophy, and uncontrolled coagulopathy (International normalized ratio > 1.5 or platelet count < 50,000 /mm3).

Design outcomes

Primary

MeasureTime frame
Technical success -At the time of completion of stent insertion, technical success was defined as the passage of the LCD stents bilaterally across the stricture using the SIS method, in a single session of ERCP

Secondary

MeasureTime frame
Functional success -Functional success was defined as a reduction in the bilirubin level of up to < 75% of the pre-treatment level, within the 1st month after the procedure.;adverse event -adverse events were defined as any stent related adverse event, including stent occlusion within 30 days of stent placement

Countries

Korea, Republic of

Contacts

Public ContactMin Jae Yang

Ajou University Hospital

creator1999@hanmail.net+82-31-219-6939

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026