Kaffes Stent in the Management of Post-surgical Biliary Strictures
Benign Biliary Stricture, Biliary Stricture, Cholangitis
About this trial
This is an interventional treatment trial for Benign Biliary Stricture
Eligibility Criteria
Inclusion Criteria:
- Confirmed benign postsurgical biliary stricture by presence of all 3 of the following:
Ultrasound imaging or Magnetic resonance cholangiopancreatography (MRCP) showing biliary dilatation, Raised bilirubin and or alkaline phosphatase, History of biliary tree surgery within the previous year
- Naïve to endoscopic therapy
- Age > 18 years
Exclusion Criteria:
- Coagulopathy
- Inability of patient to adhere to regular follow-up
- Living-donor liver transplant patients
Sites / Locations
- Kasr Alaini University HospitalRecruiting
- National hepatology and tropical medicine research instituteRecruiting
- Theodor Bilharz InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Multiple plastic stents
Metallic stent
All procedures will be performed under propofol sedation. Strictures will be identified by cholangiography and then dilated by a dilating balloon (diameter 6-10mm). A 10 French plastic stent will be inserted bypassing the level of the stricture. Stent replacement and the addition of further stents will be planned after 3 months from the initial procedure and every 3 months until stricture resolution occurs with a maximum of four procedures. Balloon dilatation with a 6-10 mm balloon will be used in each session before stent insertion.
All procedures will be performed under propofol sedation. Strictures will be identified by cholangiography and then dilated by a dilating balloon (diameter 6-10mm). A 4-6cm fully covered expandable metallic stent (Kaffes stent, Taewoong medical, Seoul, Korea) will then be deployed at the level of the stricture. In cases close to the hepatic hilum where the deployment of the stent is expected to reach one duct and possibly block another duct, a 7 Fr stent will be inserted prior to deployment of the metallic stent in the contralateral duct.. - Stent will be extracted endoscopically after 6 months.