A Randomized Controlled Trial of Endoscopic Biliary Radiofrequency Ablation of Malignant Distal Common Bile Duct Strictures.
Inclusion Criteria:
1. Age ≥ 18 years old with informed consent
2. Histologically (preferred) or radiologically confirmed distal malignant bile duct
tumors
3. Inoperability by staging, comorbidities or patient wishes
4. Distal tumors 2cm away from the portal hilum
5. Bilirubin > 50umol/L at diagnosis
Exclusion Criteria:
1. Periampullary tumours
2. Multiple hepatic metastases with significant blockage of one or more liver segments
(if no segment blockage, metastasis is not an exclusion criteria)
3. Presence of main portal vein thrombosis
4. Prior SEMS placement
5. Prior Billroth II or roux-en Y reconstruction
6. History of bleeding disorder or use of anticoagulation
7. Child's B/C cirrhosis
8. Pregnancy
9. Performance status ECOG ≥3 (confined to bed / chair > 50% waking hours)
10. Presence of other malignancy
11. Presence of gastric outlet obstruction
12. Life expectancy < 3months