Efficacy of radiofrequency ablation in malignant hilar obstruction

Efficacy of additional radiofrequency ablation in malignant hilar biliary obstruction

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0003275

Enrollment

Registered

2018-10-18

Start date

2018-12-19

Completion date

Unknown

Last updated

2024-01-22

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

Conditions

None listed

Interventions

Procedure/Surgery : All endoscopic procedures (ERCP) will be performed by an experienced pancreatobiliary endoscopist under conscious sedation with a commercially available duodenoscope (TJF-240 or TJ

STARmed, Goyang, Korea). After catheterization of the hilum, an initial cholangiogram will be obtained, and a narrow segment of the hilum will be chosen as the site for the EB-RFA with a close contact

STARmed) with a target temperature-controlled mode (80?, 7 W for 60~ 120 seconds), which can automatically terminate ablation if a certain presetting temperature is exceeded. 3. After endoscopic proce

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? 18 years and more ? Pathologically confirmed unresectable malignant hilar obstruction ? Malignant hilar obstruction due to cholangiocarcinoma or GB ca. ? Expected survival more than 3 months ? Performance status: ECOG 0~1 or Karnofsky performance >80% ? Consent to this study

Exclusion criteria

Exclusion criteria: ? Contrast allergy ? Uncontrolled coagulopathy (PT-INR > 1.5; normal 0.85-1.25, platelet count < 60,000/mm3; normal 150,000-450,000/mm3) ? Can not stop the dual anti-platelet agent ? Uncompensated LC (Child Class C) ? ESRD - Anatomical change due to surgery ? Inaccessible papilla due to failed cannulation or inaccess ? Pregnancy - Poor performance status ? Disagree with this study

Design outcomes

Primary

Measure	Time frame
Stent patency	—

Secondary

Measure	Time frame
adverse event- cholangitis;survival	—

Countries

Korea, Republic of

Contacts

Public ContactTae Hoon Lee

Soon Chun Hyang University Hospital Cheonan

taewoolee9@gmail.com+82-41-570-3662

Outcome results