IRS(Irradiation Stent) vs. CS(Conventional Stent) Insertion in Inoperable Malignant Biliary Obstruction
Condition: Malignant Biliary Obstruction
Study type: Interventional

Summary: 
      Stenting the malignant biliary obstruction is considered to be the preferred palliation
      modality to relieve pruritus,cholangitis,pain and jaundice in patients without surgical
      indications of malignant biliary obstruction.An unicentral clinical trial has demonstrated
      the safety and technical feasibility of an irradiation biliary stent insertion in patients
      with biliary obstruction caused by adenocarcinomas, such a treatment seems have benefits in
      relieving jaundice and extending survival when compared to a conventional biliary
      stent.However,the small sample size,the population distribution of two groups will influence
      the final results in obtaining a powerful statistical conclusion.Therefore,a multicentric
      study was designed to prospectively compared the responses to the treatment with this
      irradiation biliary stent versus the conventional biliary self-expandable stent in patients
      with inoperable malignant biliary obstruction.
    

Detailed description: 
      Malignant biliary obstruction is a common condition caused by various carcinomas.The clinical
      process is usually silent and insidious,only 10-20% patients can be surgically removed once
      obstructive jaundice occurred.The long-term survival rate after resection remain
      dismal.Relief of obstructive jaundice plays major role on prognosis in patients without
      surgical indications.For unresectable patients,stenting the biliary obstruction is considered
      to be the preferred palliation modality to relieve pruritus,cholangitis,pain and
      jaundice.Although a number of new techniques for treatment of malignant biliary obstruction
      have been developed,there have been no significant differences in survival or quality of life
      comparing surgery bypass versus plastic stent insertion,metal stent insertion versus plastic
      stents insertion,or covered stent versus uncovered stents insertion in such patients.Our
      previous unicentric clinical trial has demonstrated the safety and technical feasibility of a
      biliary intraluminal irradiation stent insertion in patients with biliary obstruction caused
      by adenocarcinomas, such a treatment seems have benefits in relieving jaundice and extending
      survival when compared to a conventional biliary stent.However,the small sample size,the
      population distribution of two groups will influence the final results in obtaining a
      powerful statistical conclusion in the overall survival and stent patency between two
      groups.Therefore,a multicentric study was designed to prospectively compared the responses to
      the treatment with this irradiation biliary stent versus the conventional biliary
      self-expandable stent in patients with inoperable malignant biliary obstruction.
    

Intervention name(s): Biliary SEMS loaded with 125I seeds; Conventional biliary SEMS
Intervention type(s): Device; Device
Intervention description(s): A self-expandable metallic biliary stent loaded with 125 iodine seeds is inserted in patients with inoperable malignant biliary obstruction.; A self-expandable metallic stent is inserted in patients with inoperable malignant biliary obstruction.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Malignant biliary obstruction; Obstruction/stricture; Stent; Brachytherapy; Bile duct