Endoscopic Biliary RFA of Malignant Bile Duct Obstruction
Endoscopic Biliary RFA of Malignant Bile Duct Obstruction
Endoscopic radiofrequency ablation (RFA) is a new palliation therapy for malignant bile duct
 obstruction. It delivers a high amount of thermal energy to target tissue and may prolong the
 duration of stent patency. RFA has showed promising results for malignant bile duct
 obstruction and increasing the duration of stent patency. The aim of our study was to
 evaluate the feasibility and safety of endoscopic RFA for the treatment of bile duct
 obstructions, and to compare the efficacy of Endoscopic biliary RFA with the addition of
 self-expanding metal stents (SEMS) to SEMS alone in a randomized controlled trial.
Malignant bile duct obstructions are caused by many diseases arising from primary or
 metastatic disease in intrahepatic, extrahepatic or hilar locations. To relieve obstructive
 decompression and jaundice as a result of the obstruction, endoscopic stent placement is
 usually required. Compared with surgical intervention, stent insertion offers shorter
 hospitalization, lower overall cost and lower morbidity. Previous studies have shown the
 superiority of SEMSs over plastic stents for maintaining biliary drainage. However, SEMS can
 occlude due to epithelial hyperplasia, tumor in-/overgrowth, biofilm deposition and sludge
 formation. Studies have showed that the median SEMS patency is 120 days. Once bile duct
 obstruction reoccurs, it may lead to significant morbidity and mortality. Thus, long-term
 patency of the SEMS remains an unresolved issue.

 Recently, endoscopic biliary radiofrequency ablation (RFA) have been used in patients
 suffering from inoperable malignant bile duct obstruction, and increasing the duration of
 stent patency. It delivers a high amount of thermal energy to target tissue with curative or
 palliative intent. The purpose of this study is to record information and evaluate the impact
 of radiofrequency ablation in improving the management of cholangiocarcinoma or malignant
 bile duct obstruction, and to compare the effects of SEMS plus RFA to SEMS alone.
Inclusion Criteria:

 1. Histologically (preferred) or radiologically confirmed distal malignant bile duct
 tumors

 2. Inoperability by staging, comorbidities or patient wishes

 Exclusion Criteria:

 1. History of bleeding disorder or use of anticoagulation

 2. prior cardiac pacemaker placement

 3. Presence of serious dysfunction of heart, lung or kidney.

 4. Presence of other malignancy

 5. Pregnancy

 6. Prior SEMS placement

 7. Prior Billroth II or roux-en Y reconstruction