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临床试验/NCT02582541
NCT02582541Unknown不适用

Endoscopic Biliary Radiofrequency Ablation of Malignant Bile Duct Obstruction

The Second Hospital of Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2014年2月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
Stent patency rate

研究概览

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

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)

研究者

发起方
The Second Hospital of Nanjing Medical University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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