Post-surgical biliary strictures are common especially after cholecystectomy. Standard treatment involves the performance of multiple procedures over a 1 year period at least using several plastic stents to achieve permanent dilatation of these strictures. Metallic stents have the theoretical benefit of absence of need of multiple sessions. These strictures however are frequently very close to the hilum and thus previously considered a contraindication for insertion of metallic stents for the fear of occlusion of the contralateral ducts. Metallic stent migration is also a frequent problem. The use of a metallic stent that is short and completely intraductal, in theory, should reduce the risk of stent migration. This is a randomized controlled trial comparing the efficacy and safety of a short metallic intraductal stent to the conventional treatment which is multiple plastic stents. In cases with a stricture reaching or close to the hilum a technique is used to avoid obstruction of the contralateral ducts which is insertion of a 7 French plastic stent alongside the metallic stent.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
30
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.
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.
Kasr Alaini University Hospital
Cairo, New Cairo, Egypt
RECRUITINGNational hepatology and tropical medicine research institute
Cairo, Egypt
RECRUITINGTheodor Bilharz Institute
Cairo, Egypt
RECRUITINGClinical success
Proportion of patients with Absence of clinical or laboratory evidence of recurrence of biliary obstruction
Time frame: 6 months after removal of stents
Technical success
Proportion of patients with Successful deployment of stents
Time frame: At time of procedure
Stricture resolution at end of treatment
Radiological resolution of the stricture at the time of removal of the stents (after insertion of 3 or 4 stents) and after removal of the metallic stent.
Time frame: After 6 months in the metallic stent group and after 12 or 15 months in the multiple plastic stents group
Occurrence of complications
occurence of any procedure-related complication
Time frame: up to 6 months after the last procedure
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