Prospective international multicenter study on endoscopic ultrasound-guided biliary drainage for patients with malignant distal biliary obstruction after failed endoscopic retrograde cholangiopancreatography.
Endosc Int Open
; 4(4): E487-96, 2016 Apr.
Article
em En
| MEDLINE
| ID: mdl-27092334
ABSTRACT
BACKGROUND AND AIMS:
Endoscopic ultrasound-guided biliary drainage (EUS-BD) has emerged as an alternative to traditional radiologic and surgical drainage procedures after failed endoscopic retrograde cholangiopancreatography (ERCP). However, prospective multicenter data are lacking. The aims of this study were to prospectively assess the short- and long-term efficacy and safety of EUS-BD in patients with malignant distal biliary obstruction. PATIENTS ANDMETHODS:
Consecutive patients at 12 tertiary centers (5 US, 5 European, 1 Asian, 1 South American) with malignant distal biliary obstruction and failed ERCP underwent EUS-BD. Technical success was defined as successful stent placement in the desired position. Clinical success was defined as a reduction in bilirubin by 50â% at 2 weeks or to below 3âmg/dL at 4 weeks. Adverse events were prospectively tracked and graded according to the American Society for Gastrointestinal Endoscopy (ASGE) lexicon's severity grading system. Overall survival and duration of stent patency were calculated using Kaplan-Meier analysis.RESULTS:
A total of 96 patients (mean age 66 years, female 45â%, pancreatic cancer 55â%) underwent EUS-BD. Stent placement (technical success) was achieved in 92 (95.8â%) patients (metallic stent 84, plastic stent 8). Mean procedure time was 40 minutes. Clinical success was achieved in 86 (89.5â%) patients. A total of 10 (10.5â%) adverse events occurred pneumoperitoneum (nâ=â2), sheared wire (nâ=â1), bleeding (nâ=â1), bile leak (nâ=â3), cholangitis (nâ=â2), and unintentional perforation (nâ=â1); 4 graded as mild, 4 moderate, 1 severe, and 1 fatal (due to perforation). A total of 38 (44â%) patients died of disease progression during the study period. The median patient survival was 167 days (95â%CI 112â-â221) days. The 6-month stent patency rate was 95â% (95â%CI 94.94â-â95.06â%) and the 1-year stent patency was 86â% (95â%CI 85.74â-â86.26â%).CONCLUSION:
This study on EUS-BD demonstrates excellent efficacy and safety of EUS-BD when performed by experts. STUDY REGISTRATION NCT01889953.
Texto completo:
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Coleções:
01-internacional
Base de dados:
MEDLINE
Tipo de estudo:
Clinical_trials
Idioma:
En
Revista:
Endosc Int Open
Ano de publicação:
2016
Tipo de documento:
Article
País de afiliação:
Estados Unidos