Treatment of endobiliary radiofreqeuncey ablation for the treatment of malignant extrahepatic biliary stricture

Clinical utility of endobiliary radiofrequency ablation for the treatment of malignant extrahepatic biliary stricture: A multicenter randomized controlled trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0003373

Enrollment

147

Registered

2018-11-25

Start date

2019-03-25

Completion date

Unknown

Last updated

2024-08-19

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 : study group: uncovered metal stent insertion to biliary stircture afterl biliary radiofreqeuncy ablation control group: uncovered metal stent insertion to biliary stircture

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Malignant extrahepatic bile duct stricture (histopathologically confirmed or malignant bile duct stenosis is judged through clinical course). If surgical resection is not possible, or high-risk surgical operation or patient does not want surgery 2. Malignant biliary stricture caused by cholangiocarcinoma, gallbladder cancer and pancreatic cancer 3. The bile duct stricture is at least 1 cm away from the hilar bile duct 4. The predicted survival period is more than 3 months 5. Performance status: ECOG 0 ~ 1 or Karnofsky performance> 80% 6. patient who agree to participate in this study and complete the patient consent form

Exclusion criteria

Exclusion criteria: 1. Inadequate for ERCP 2. More than 14 days after ERCP, EST, or ERBD / ENBD 3. Uncontrolled blood coagulation disorders (PT-INR> 1.5; normal 0.85-1.25, platelet count <60,000 / mm3; normal 150,000-450,000 / mm3) 4. Patients who can not stop taking dual anti-platelet agents (eg, patients with coronary artery disease undergoing coronary vascular stenting within one year) 5. Child C grade uncompensated cirrhosis patient 6. End-stage renal failure 7. ultered bile duct anatomy due to previous surgical operation 8. Failure of duodenal access to the duodenal papilla or failure of selective bile duct cannulation 9. pregnancy or lactating 10. patient who disagree with participation in this study 11. Uncooperative patients during ERCP procedure 12. Patients with poor performance status 13. Ampullary cancer 14. Intraductal papillary mucinous neoplasm in bile duct (IPN-B)

Design outcomes

Primary

Measure	Time frame
Stent patent period	—

Secondary

Measure	Time frame
overall early complication rate;technical success of RFA;Clinical success after metal stenting;late complication rate;the period of patient`s survival;The rescue method for the stent dysfunction	—

Countries

Korea, Republic of

Contacts

Public ContactSeok Jeong

Inha University Hospital

sjlovesercp@gmail.com+82-32-890-2548

Outcome results