EUS-guided transmural gallbladder drainage: a new era has begun

The first line management of acute cholecystitis remains surgery for patients who are good operative candidates. In high-risk operative candidates, a conservative approach of intravenous fluids and antibiotics is recommended. In those who fail conservative management, nonsurgical decompression of the gallbladder is urgently needed to prevent sepsis, perforation and death. Percutaneous gallbladder drainage (PTGBD) has been described since the 1970s [Elyaderani and Gabriele, 1979]. This can be performed with gallbladder puncture under transabdominal ultrasound or computed tomography (CT) guidance followed by placement of an indwelling 6-10 French pigtail catheter drain [Akhan et al. 2002]. This technique has been well studied with prospective data and randomized trials showing success rates upwards of 95% [Ito et al. 2004; Hatzidakis et al. 2002; Sugiyama et al. 1998]. However, PTGBD has significant complications including bleeding, bile leak, bile peritonitis, pneumothorax, bowel perforation, secondary infections and catheter dislodgement [Akhan et al. 2002]. In addition, it cannot be performed in patients with ascites or those on anticoagulants. The need for leaving an exterior drainage tube can be burdensome and uncomfortable, requiring multiple sessions [Kedia et al. 2015] and tube dislodgement occurs in 0.3–12% of patients [Ito et al. 2004, Hatzidakis et al. 2002, Kiviniemi et al. 1998]. Interestingly percutaneous drainage of the gallbladder has been increasingly used in an attempt to ‘cool off’ the gallbladder and facilitates a future resection.

With the evolution of endoscopic ultrasound (EUS) techniques for pseudocyst and biliary drainage, new methods for transmural gallbladder drainage have emerged. The first series on EUS-guided transmural gallbladder drainage (EUS-GBD) by Kwan and colleagues included only three patients and described both transgastric and transduodenal approaches to gallbladder puncture followed by placement of an internal plastic double pigtail biliary stent across the tract along with a transnasal gallbladder drain [Kwan et al. 2007]. Subsequent case series describing a similar technique with use of plastic biliary stents across the transmural tract all reported high success rates of 100% [Lee et al. 2007; Song et al. 2010; Sutil et al. 2012; Kamata et al. 2009]. However plastic stents placement can be associated with bile leak with subsequent bile peritonitis due to tract dilation during placement [Jang et al. 2011]. This has led to placing partially covered self-expanding metal stents (SEMSs), which can ‘seal the gap’ between the gallbladder lumen and the bowel. Fins or flanges on the end of the SEMS can also prevent stent migration [Jang et al. 2011; Widmer et al. 2014]. In the series of 15 patients studied by Jang and colleagues there was technical success in all cases with no adverse events due to stent migration or bile leak; two patients had self-limited pneumoperitoneum [Jang et al. 2011]. Finally, the newest innovation in EUS-GBD is the lumen apposing stent (LAMS) (AXIOS; Xlumena Inc., CA, USA) with a 10 or 15 mm luminal diameter and dumbbell shaped flanges to bring together the 2 walls in apposition. These features of the AXIOS stent decrease risk for bile leak, stent migration and stent occlusion [Itoi et al. 2012].

The pilot study by Takagi and colleagues published in this issue presents the results of EUS-guided cholecystoduodenostomy using a fully covered SEMS (BONA stent, Standard Sci Tech Inc., Seoul, Korea) followed by a 7-Fr pigtail plastic stent with gallbladder puncture done exclusively transduodenally to access the gallbladder neck [Takaki et al. 2015]. The tandem SEMS and plastic stent approach was proposed to prevent stent migration and food entry into the gallbladder after tract formation. There has been one report of food impaction of a SEMS leading to recurrent cholecystitis after EUS-GBD [Choi et al. 2014] and there is a theoretical risk for food or sludge flowing from the intestinal side into the gallbladder to across a patent cystic duct and into biliary tree causing obstruction or cholangitis. Takagi and colleagues chose the gallbladder neck for puncture to allow optimal apposition of the gallbladder against the duodenum to prevent bile leak and to allow the top end of the SEMS to lie across the cyst duct in such a way as to mechanically obstruct it. In their series of 16 patients, technical success was achieved in all with only 1 case of self-limited pneumoperitoneum and no other adverse events due to bile leak, stent migration, recurrent cholecystitis or cholangitis.

Taken together, the accumulated evidence to date shows that EUS-GBD is a feasible and safe alternative to PTGBD in patients who are poor surgical candidates. The technical success of EUS-GBD is consistently 100% in recent series, and evolving techniques and newer devices are aimed at minimizing the few adverse events associated with this procedure. A prospective, randomized, head-to-head comparison of PTGBD and EUS-GBD LAMS (AXIOS, BSC) stents is currently in progress with preliminary data in favor of LAMS [ClinicalTrials.gov identifier:NCT02212717]. It is clear that EUS-GBD has started a new era of therapeutic EUS and will become more widely adopted as a safe, effective and viable non-surgical option for treating gallbladder disease.