Comparison of endoscopic radiofrequency ablation versus stenting alone for the treatment of unresectable malignant biliary obstruction

Comparison of endoscopic radiofrequency ablation combined with biliary stenting versus stenting alone for the treatment of unresectable malignant biliary obstruction : Prospective randomized controlled pilot study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0004623

Enrollment

Registered

2020-01-13

Start date

2020-07-23

Completion date

Unknown

Last updated

2022-11-28

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 : study group: the group with insertion of plastic stent after endoscopic RFA control groups: the group with insertion of stent alone

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? pathologically diagnosed malignant biliary obstruction (bile duct cancer, pancreatic cancer, gallbladder cancer, etc) ? over 19 years of age ? expected life expectancy of 3 months or more ? in cases where it cannot be resected due to advanced stage or accompanying diseases ? patients who agree to participate in this study and complete the patient consent form

Exclusion criteria

Exclusion criteria: ? in case that ERCP cannot be performed due to general condition ? in case that the anatomical structure of the bile duct has been modified due to past surgery ? in case that endoscopic approach to duodenum or bile duct is not available ? in case that stent procedure, chemotherapy or radiation therapy was performed after malignant biliary obstruction was diagnosed in the past

Design outcomes

Primary

Measure	Time frame
Stent patent period	—

Secondary

Measure	Time frame
the period of survival;early complication rate;late complication rate;technical success of RFA	—

Countries

Korea, Republic of

Contacts

Public ContactHyung-Keun Kim

The Catholic University of Korea, Uijeongbu St. Mary’s Hospital

hykkim1@gmail.com+82-31-820-3016

Outcome results