There are doubts concerning the possible benefits derived from the insertion of double-pigtail plastic stents (DPS) within the lumen-apposing metal stents (LAMS) in the EUS-guided transmural biliary drainage (BD). The aims was to evaluate the safety of LAMS with and without a coaxial DPS in EUS-BD for the palliative management in malignant biliary obstruction.
Study Type
OBSERVATIONAL
Enrollment
39
Endosonography-guided biliodigestive anastomosis using a dedicated biliary lumen-apposing stent in order to proveide a biliary drainage in cases of palliative malignant biliary obstruction. Two different strategies will be compared: single lumen-apposing stent vs lumen-apposing stent plus dousble-pigtail plastic stent.
Hospital Universitari Mútua de Terrassa
Terrassa, Barcelona, Catalonia, Spain
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital de Sant Pau i de la Santa Creu
Barcelona, Catalonia, Spain
Potential benefits
to respond if a coaxial DPS within a biliary LAMS really has a potential benefit in the EUS-BD (less number of adverse events: cholangitis, bleeding, sump syndrome, cholestasis secondary to stent biliary obstruction)
Time frame: 4 weeks
Technical success
Technical success was defined as a successful stent placement between the extrahepatic bile duct and duodenal lumen in a single step approach and determined by endoscopy and fluoroscopy
Time frame: 24 hours
Clinical success
Clinical success was defined as a reduction in bilirubin by 50% at 2-weeks after stent placement, meaning that the biliary stent was functional.
Time frame: 4 weeks
Procedure time
Procedure time was defined from the insertion of the endoscope to its removal.
Time frame: 2 hours
Biliary reintervention
Biliary reintervention: the need to perform additional interventions to achieve biliary drainage.
Time frame: 6 months
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