scholarly journals Endoscopic biliary drainage in unresectable biliary obstruction: the role of endoscopic ultrasound-guidance in a cohort study

Author(s):  
Manuel Puga ◽  
Nat�lia Pallar�s ◽  
Julio Velásquez-Rodríguez ◽  
Albert García-Sumalla ◽  
Claudia F. Consiglieri ◽  
...  
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.


Endoscopy ◽  
2020 ◽  
Vol 53 (01) ◽  
pp. 55-62 ◽  
Author(s):  
Pradermchai Kongkam ◽  
Theerapat Orprayoon ◽  
Chaloemphon Boonmee ◽  
Passakorn Sodarat ◽  
Orathai Seabmuangsai ◽  
...  

Abstract Background Endoscopic retrograde cholangiopancreatography (ERCP) may not provide complete biliary drainage in patients with Bismuth III/IV malignant hilar biliary obstruction (MHBO). Complete biliary drainage is accomplished by adding percutaneous transhepatic biliary drainage (PTBD). We prospectively compared recurrent biliary obstruction (RBO) rates between combined ERCP and endoscopic ultrasound-guided biliary drainage (EUS-BD) vs. bilateral PTBD. Methods Patients with MHBO undergoing endoscopic procedures (group A) were compared with those undergoing bilateral PTBD (group B). The primary outcome was the 3-month RBO rate. Results 36 patients were recruited into groups A (n = 19) and B (n = 17). Rates of technical and clinical success, and complications of group A vs. B were 84.2 % (16/19) vs. 100 % (17/17; P = 0.23), 78.9 % (15/19) vs. 76.5 % (13/17; P > 0.99), and 26.3 % (5/19) vs. 35.3 % (6/17; P = 0.56), respectively. Within 3 and 6 months, RBO rates of group A vs. group B were 26.7 % (4/15) vs. 88.2 % (15/17; P  = 0.001) and 22.2 % (2/9) vs. 100 % (9/9; P = 0.002), respectively. At 3 months, median number of biliary reinterventions in group A was significantly lower than in group B (0 [interquartile range] 0–1 vs. 1 [1–2.5]), respectively (P < 0.001). Median time to development of RBO was longer in group A than in group B (92 [56–217] vs. 40 [13.5–57.8] days, respectively; P  =  0.06). Conclusions Combined ERCP and EUS procedures provided significantly lower RBO rates at 3 and 6 months vs. bilateral PTBD, with similar complication rates and no significant mortality difference.


2020 ◽  
Vol 35 (12) ◽  
pp. 2103-2108 ◽  
Author(s):  
Huiyun Zhu ◽  
Pei Xie ◽  
Yuxin Wang ◽  
Zhendong Jin ◽  
Zhaoshen Li ◽  
...  

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