Eus-giuded Biliary Drainage With Ec-lams vs ERCP as a Primary Intervention for Endoscopic Treatment of Patinets With Distal Malignant Biliary Obstruction
Eus-giuded Biliary Drainage With Ec-lams vs ERCP as a Primary Intervention for Endoscopic Treatment of Patinets With Distal Malignant Biliary Obstruction
Endoscopic retrograde cholangiopancreatography (ERCP) is the gold standard for the management
 of jaundice in patients with distal malignant biliary obstruction. However, surgically
 altered anatomy (i.e., Whipple intervention, Roux-en-Y gastric bypass, Billroth II surgery),
 periampullary diverticula, gastric outlet obstruction, and malignant obstruction of the lumen
 determine the failure of the procedure in about 5-10% of cases, requiring alternative methods
 of decompression. Percutaneous transhepatic biliary drainage (PTBD) and surgical bypass are
 well established alternatives in these patients, but associated with increased morbidity,
 longer length of hospital stay and higher costs.

 EUS guided biliary drainage (EUS-BD) through a transduodenal access is an alternative in
 cases of failed or unfeasible ERCP. EUS-BD has considerably evolved thanks to the development
 of dedicated devices such as lumen apposing metal stents (LAMS), specifically designed for
 endoscopic ultrasound procedures. LAMS are made up of braided nitinol that is fully covered
 with silicone to prevent tissue ingrowth, with wide flanges on both ends to provide
 anchorage.

 Recently, LAMS have been incorporated into a delivery system with an electrocautery mounted
 on the tip (Hot Axios; Boston Scientific Corp.), which allows the device to be used directly
 to penetrate the target structure without the need to utilize a 19G needle, a guidewire, and
 a cystotome for prior dilation. This has been described for drainage of peri-pancreatic fluid
 collections, common bile duct (CBD), gallbladder, and for creation of gastro-jejuno
 anastomosis. The biliary drainage procedure performed with the Hot Axios sistem is a fast,
 one-step procedure that obviates the need accessory exchange and thus potentially reduces the
 risk of complications.

 The procedure has been described as safe and effective with a technical success of 98.2%,
 clinical success of 96.4%, and low rate of complications 7% (consisting of duodenal
 perforations, bleeding and transient cholangitis).

 Patients with distal malignant biliary obstruction have a higher risk of ERCP failure,
 related to the difficulty of bile duct cannulation or access to the second duodenal portion
 due to the presence of a stenosis. This condition could imply the need of more advanced
 cannulation techniques (such as pre-cut, Double Guide Wire DGW technique, pancreatic
 septotomy) with consequent higher risk of developing post ERCP pancreatitis (PEP). Unlike
 ERCP, an reaching the papilla is not a requisite for a successful EUS-BD. Moreover, since the
 papilla is not cannulated and the pancreatic duct is not accessed, this is expected to result
 in a minimal risk of post-procedural pancreatitis (about 0.50%).

 The investigators hypothesize that, in patients with distal malignant biliary obstruction,
 EUS guided biliary drainage as first step approach has a lower risk of post-procedural
 pancreatitis compared to standard ERCP. The investoigators propose to perform a randomized
 controlled study to test this hypothesis.
Inclusion Criteria:

 -  Age ≥18 years

 -  Patients with distal malignant biliary obstruction

 -  Abdominal ultrasound or computed tomography or magnetic resonance or EUS showing
 a dilated common bile duct > 15 mm diameter.

 -  Agree to receive follow up phone calls

 -  Able to provide written informed consent

 Exclusion Criteria:

 -  Coagulation and/or platelets hereditary disorders and/or INR>1.5, PLT<50,000.

 -  Use of anticoagulants that cannot be discontinued

 -  Pregnant women

 -  Inability to sign the informed consent