Clinical Trial Summary
Distal malignant biliary obstruction results from different types of tumors including
pancreatic cancer, biliary tract cancer (BTC), gallbladder cancer, and metastasis, which can
lead to obstructive jaundice. Endoscopic retrograde cholangiopancreatography (ERCP)
represents the gold standard for jaundice palliation in this setting of patients. 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 stays and higher costs, and patient
discomfort.
In 2001 Giovannini et al. described the first EUS guided biliary drainage (EUS-BD) through a
transduodenal access with a needle knife. Subsequently, 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 LAMS is a one step procedure that
requires less or no need for accessory exchange and becomes faster, thus potentially
decreasing 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 % (duodenal perforations,
bleeding and transient cholangitis) [6]. A systematic review and meta-analyses showed
clinical and technical success rates of 87% and 95% respectively [7]. Currently, the EUS-BD
is indicated as a rescue therapy for jaundice palliation after ERCP failure. Actually, only a
retrospective series is published in literature about the gallbladder (GB) drainage in
patients with malignant biliary obstruction (MBO), demonstrating the feasibility of
gallbladder drainage to relieve malignant distal bile duct obstruction in patients with
failed ERCP. No data are actually reported, especially in a prospective way, about the GB
drainage as first intention in patients with MBO.
