Biliary Obstruction, Hilar Cholangiocarcinoma
Conditions
Keywords
Hilar cholangiocarcinoma, Biliary obstruction, Radiofrequency ablation
Brief summary
The study aim to evaluate the efficacy of intraductal radiofrequency ablation for unresetable hilar cholangiocarcinoma in addition to biliary stenting. The patient would be randomized into 1:1 ratio of conventional group who received biliary stenting alone, and RFA group who receive intraductal RFA before biliary stenting. Immediate complications as well as long term stent patency and patient survival would be studied.
Detailed description
Study design: randomized single-blind control trial Study population: patient with unresectable hilar cholangiocarcinoma with obstructive jaundice who need hilar biliary stenting Primary endpoint: Biliary stent patency time Secondary endpoint: Patient survival Intervention 1. Recruited patients randomly assigned into 2 groups, conventional and RFA group by sealed enveloped 2. All patients receive endoscopic biliary stenting. Those in RFA group receive RFA before biliary stent. 3. Monitor for adverse event during hospitalization and during follow up 4. Follow up as outpatient in 4-weekly interval with monitoring of serum liver function test as routine
Interventions
DEVICEELRA endoluminal radiofrequency ablation electrode (Taewoong, Seoul, Korea)
Intraductal radiofrequency ablation using ELRA endoluminal radiofrequency ablation electrode (Taewoong, Seoul, Korea) 10W 2 minutes at the obstructed bile duct before placing uncover self-expandable biliary metal stent
Sponsors
Department of Medical Services Ministry of Public Health of Thailand
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Hilar cholangiocarcinoma diagnosed by imaging or pathology * Considered unresectable or unfit for surgery * Presence of obstructive jaundice need endoscopic biliary drainage
Exclusion criteria
* History of unremovable metallic biliary stent placement * severe biliary stricture that the instrument was unable to pass through * unfit for endoscopic under conscious sedation * loss to follow up and loss contact within 6 months after intervention
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biliary stent patency | up to 6 months | The duration between primary intervention and first recurrent increased in serum total bilirubin after intervention up to 6 months after the primary procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient survival | up to 6 months | Survival time after primary intervention and documented patient death at 6 months after primary intervention |
Countries
Thailand
Outcome results
None listed