Endoscopic Biliary Radiofrequency Ablation of Malignant Bile Duct Obstruction
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Cholangiocarcinoma
- 发起方
- The Second Hospital of Nanjing Medical University
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Stent patency rate
- 最后更新
- 10年前
概览
简要总结
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.
详细描述
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.
研究者
入排标准
入选标准
- •Histologically (preferred) or radiologically confirmed distal malignant bile duct tumors
- •Inoperability by staging, comorbidities or patient wishes
排除标准
- •History of bleeding disorder or use of anticoagulation
- •prior cardiac pacemaker placement
- •Presence of serious dysfunction of heart, lung or kidney.
- •Presence of other malignancy
- •Prior SEMS placement
- •Prior Billroth II or roux-en Y reconstruction
结局指标
主要结局
Stent patency rate
时间窗: 6 months
次要结局
- Overall survival(3 years)
- Number of Participants with Adverse Events(30 days)
- Change from Baseline in Bile Duct Stricture Diameter(3 years)