scholarly journals Prospective international multicenter study on endoscopic ultrasound-guided biliary drainage for patients with malignant distal biliary obstruction after failed endoscopic retrograde cholangiopancreatography

2016 ◽  
Vol 04 (04) ◽  
pp. E487-E496 ◽  
Author(s):  
Mouen Khashab ◽  
Schalk Van der Merwe ◽  
Rastislav Kunda ◽  
Mohamad El Zein ◽  
Anthony Teoh ◽  
...  
2019 ◽  
Vol 12 ◽  
pp. 263177451988945
Author(s):  
Ahmed Youssef Altonbary ◽  
Ahmed Galal ◽  
Mohamed El-Nady ◽  
Hazem Hakim

Background and aim: Endoscopic ultrasound-guided biliary drainage is an alternative to failed endoscopic retrograde cholangiopancreatography. Unfortunately, this procedure remains relatively less explored in Egypt due to its high cost, lack of adequate training, and the perception of increased risk. This study is the first multicenter Egyptian experience of an endoscopic ultrasound-guided biliary drainage in patients with malignant biliary obstruction. Patients and methods: We retrospectively reviewed 15 patients (10 men and five women) with malignant biliary obstruction who from October 2013 to May 2019, following a failed or inaccessible endoscopic retrograde cholangiopancreatography, underwent an endoscopic ultrasound-guided choledochoduodenostomy, endoscopic ultrasound-guided hepaticogastrostomy, or endoscopic ultrasound-guided rendezvous. Their mean age was 57.4 years and mean bilirubin was 18.2 mg/dL. The outcome parameters included technical and clinical success. Technical success was defined as the successful placement of a stent in the biliary system, while clinical success was defined as a greater than 50% decrease in the bilirubin levels 2 weeks after the procedure. Patients were monitored for complications during and after the procedure. Results: In total, 15 patients underwent endoscopic ultrasound-guided biliary drainage (eight underwent endoscopic ultrasound-guided choledochoduodenostomy, five underwent endoscopic ultrasound-guided hepaticogastrostomy, and two underwent endoscopic ultrasound-guided rendezvous). The technical and clinical success rates were 100% (15/15 patients) and 93.3% (14/15 patients), respectively. The complication rate was 26.6% (4/15 patients). All complications were mild and self-limited, and included fever, mild biliary peritonitis, pneumoperitoneum, and a slight migration of one plastic stent during insertion. Conclusion: Although slowly gaining acceptance in Egypt, endoscopic ultrasound-guided biliary drainage is an effective and safe procedure in patients with a malignant biliary obstruction after a failed or inaccessible endoscopic retrograde cholangiopancreatography.


Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Yen-I Chen ◽  
◽  
Kashi Callichurn ◽  
Avijit Chatterjee ◽  
Etienne Desilets ◽  
...  

Abstract Background & aims Endoscopic ultrasound guided-biliary drainage (EUS-BD) is a promising alternative to endoscopic retrograde cholangiopancreatography (ERCP); however, its growth has been limited by a lack of multicenter randomized controlled trials (RCT) and dedicated devices. A dedicated EUS-BD lumen- apposing metal stent (LAMS) has recently been developed with the potential to greatly facilitate the technique and safety of the procedure. We aim to compare a first intent approach with EUS-guided choledochoduodenostomy with a dedicated biliary LAMS vs. standard ERCP in the management of malignant distal biliary obstruction. Methods The ELEMENT trial is a multicenter single-blinded RCT involving 130 patients in nine Canadian centers. Patients with unresectable, locally advanced, or borderline resectable malignant distal biliary obstruction meeting the inclusion and exclusion criteria will be randomized to EUS-choledochoduodenostomy using a LAMS or ERCP with traditional metal stent insertion in a 1:1 proportion in blocks of four. Patients with hilar obstruction, resectable cancer, or benign disease are excluded. The primary endpoint is the rate of stent dysfunction needing re-intervention. Secondary outcomes include technical and clinical success, interruptions in chemotherapy, rate of surgical resection, time to stent dysfunction, and adverse events. Discussion The ELEMENT trial is designed to assess whether EUS-guided choledochoduodenostomy using a dedicated LAMS is superior to conventional ERCP as a first-line endoscopic drainage approach in malignant distal biliary obstruction, which is an important and timely question that has not been addressed using an RCT study design. Trial registration Registry name: ClinicalTrials.gov. Registration number: NCT03870386. Date of registration: 03/12/2019.


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