Int J Gastrointest Interv 2020; 9(4): 148-153
Published online October 31, 2020 https://doi.org/10.18528/ijgii200046
Copyright © International Journal of Gastrointestinal Intervention.
Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong, Shatin, Hong Kong
Correspondence to:* Corresponding author. Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong, 4/F Li Ka Shing Medical Sciences Building, Ngan Shing St., Shatin, Hong Kong.
E-mail address: firstname.lastname@example.org (A.Y.B. Teoh).
This is an open-access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0) which permits unrestricted noncommercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Endoscopic ultrasonography-guided gallbladder drainage (EUS-GBD) has emerged as a promising alternative treatment to high-risk patients suffering from acute cholecystitis and are unfit for surgery. EUS-GBD has similar rates of technical and clinical success compared to other alternative treatments, but the procedure has been shown to reduce adverse event rates and the need for repeated interventions. This review aims to provide a summary of the recent development in the EUS-GBD technique with various devices employed in the procedure.
Keywords: Acute cholecystitis, Endoscopic ultrasonography-guided gallbladder drainage, Malignant biliary obstruction, Percutaneous cholecystostomy
Laparoscopic cholecystectomy (LC) is the treatment of choice for patients suffering from acute cholecystitis (AC). In patients that are at very high risk for cholecystectomy, temporary drainage of the gallbladder may be required.1 Conventionally, the gallbladder could be drained by two approaches, namely, percutaneous transhepatic gallbladder drainage (PT-GBD) and endoscopic transpapillary gallbladder drainage (ET-GBD).1,2 PT-GBD is associated with several short and long term issues including dysfunctional cholecystostomy tube (46%) and recurrence of AC (41%) requiring repeated interventions (28%).3,4 Meanwhile, ET-GBD is associated with a lower success rate when compared to PT-GBD but avoids the presence of an external tube.2 Thus, an alternative approach of draining the gallbladder with higher technical success and lower adverse events rate is required.
Since 2007, endoscopic ultrasonography-guided gallbladder drainage (EUS-GBD) has emerged as the third alternative for draining the gallbladder in AC. EUS-GBD has been reported to be more advantageous than PT-GBD with reduced adverse events, number of re-interventions, hospital stay, postprocedural pain scores and fewer unplanned admissions whilst the clinical and technical success rates are comparable.5,6 In 2018, the revised Tokyo Guideline has included EUS-GBD as one of the treatment modalities for non-surgical management of AC.1 Moreover, there are some variations in the technique of EUS-GBD to incorporate different types of puncture routes, stents and stent delivery systems. In this review, we describe the latest techniques and advancements of EUS-GBD.
There are several potential indications for EUS-GBD. Firstly, EUS-GBD could be offered as an option for gallbladder drainage in elderly patients suffering from AC that are at very high risk for cholecystectomy.7 Secondly, EUS-GBD could be used to convert long-term cholecystostomy to internal drainage.8,9 Finally, EUS-GBD could be used for drainage of the biliary tract for malignant biliary obstruction after failed endoscopic retrograde cholangiopancreatography (ERCP) and EUS-guided biliary drainage.10,11
The stenting device used in the first few pioneering studies were nasobiliary drainage tubes or plastic stents.12,13 However, the use these stents do not impart lumen to lumen adherence for maintenance of tight organ anastomosis and may risk leakage of intestinal contents. Thereafter, the use of fully covered self-expandable metal stent (cSEMS) were described. cSEMS are more advantageous over plastic stents as they provide better sealing of the fistula tract between gallbladder wall and the gastrointestinal lumen and hence may reduce the risk of leak.14 However, placement of cSEMS requires progressive dilation of the fistula tract and this could lead to longer procedure time and risk leakage of gastrointestinal contents or air to the peritoneal cavity during exchange of instruments. Furthermore, stent migration and stent impingement onto adjacent organs could occur with the use of cSEMS.15 Hence, further improvement of the stenting device is required.
Recently, lumen-apposing metal stent (LAMS) has been developed for EUS-GBD. The design rationale of LAMS is to generate adequate lumen apposing force to anastomose two non-adherent organs and to prevent stent migration.16 Currently, there is no consensus on what properties LAMS should constitute but these stents share several similarities in design. The stents are composed of braided nitinol covered entirely with silicone and have bilateral flanges to prevent migration, they are short in length but have a large lumen diameter. In an
EUS-GBD can be performed by the conventional technique or direct puncture with a cautery enhanced delivery system. Regardless of the technique, the endoscopist also needs to decide on the site of puncture. The gallbladder can be drained from the distal gastric antrum and the duodenum.18 Depending on the puncture site, the access site at the gallbladder will vary. The gallbladder is generally accessed at the neck or infundibulum through punctures from duodenum. Meanwhile, the gallbladder is accessed at the fundus or body through puncture at the distal gastric antrum.19 In general, the neck or body of the gallbladder is chosen as the optimal target for puncture under the guidance of EUS.10 The factors affecting the selection of puncture site involve presence of vessels between the gastric or duodenal wall and the gallbladder wall, presence of duodenal stenosis and the distance between the gastric or duodenal wall to the gallbladder wall. However, it should be noted that transgastric punctures may be increase the risk of stent migration or even dislocation as stomach is relatively more mobile.19 Stent migration could result in bile leakage into the peritoneal space, which may lead to bile peritonitis.10 Furthermore, there may be a risk of food impaction in the gallbladder and also the risk of buried stent syndrome. However, Teoh et al5 has reported that both antral and duodenal puncture routes share similar clinical and technical success rate and risk of adverse events. Nevertheless, it is the author’s preference to drain the gallbladder from the duodenum.
A number of devices are required for accessing the gallbladder from the gastrointestinal tract and dilating the fistula tract. These include a 19-gauge fine-needle aspiration needle, 6-Fr cystotome, needle-knife and a 4 mm dilating balloon. The gallbladder is first punctured with a 19-gauge needle, bile is then aspirated out to confirm that the needle is in gallbladder and to obtain sample for bacterial culture to identify the appropriate antibiotic therapy.20 Contrast injection is generally not required as presence of bile aspirate indicates that the needle is in proper position. A guidewire is then inserted through the needle to the gallbladder and is allowed to coil within for the track dilation and stent insertion later. Common choices of guidewire include 0.035-inch, 450 cm-long guidewire (Jagwire; Boston Scientific, Marlborough, MA, USA) or 0.025-inch guidewire (Visiglide; Olympus, Tokyo, Japan). After the insertion of guidewire, a dilator is required for fistula dilation and these can be cautery or non-cautery dilators.21,22 For cautery dilators, a 6Fr cystotome or needle-knife can be used. The cystotome is generally preferred as it provides a radial cautery on the guidewire to create the fistula. Afterwards, the track is further dilated by non-cautery dilators. A 6Fr-7Fr-9Fr Biliary dilation catheter or balloon dilator (4 mm) are the commonly employed devices.22 Thereafter, the stent is inserted into the gallbladder and deployed between the gallbladder and gastrointestinal lumen. Depending on the type of stent that is being used, the method of deployment may vary. For LAMS, the distal flange is usually deployed under EUS guidance, followed by intra-channel deployment of the proximal flange and pushing the stent out of the endoscope channel under endoscopic guidance.
Recently, EUS-GBD with a cautery-tipped stent delivery system (HOT AXIOS; Boston Scientific) and (SPAXUS; Taewoong Medical, Gimpo, Korea) that allows the insertion of a lumen-apposing stent without the need of a dilation device has been described.17 The distal tip of this stent delivery system was modified to incorporate a cautery tip for direct puncture and eliminates the need of a multi-stepped fistula track dilation. Thereafter, the stent is deployed as described above (Fig. 1–5). According to a multi-centered retrospective study, this one-step system has proven to reduce the procedural time significantly which can in theory reduce the risk of fluid leakage and adverse events compared with the conventional technique (3.1 vs 7.7 minutes,
Table 1 . Summary of Recent Publications on Endoscopic Ultrasonography-Guided Gallbladder Drainage.
|Author||Year||Stent||No. of patients||Technical success||Clinical success||Adverse event||Repeat intervention|
|Jang et al29||2012||Nasobiliary drainage tube||30||29 (96.7)||29 (96.7)||2 (6.7)||Not accessed|
|Choi et al30||2014||DONA-AL||63||62 (98.4)||62 (98.4)||3 (4.8)||2 (2.6)|
|Kedia et al6||2015||Nasobiliary drainage tube||30||30 (100)||26 (86.7)||4 (13.3)||4 (13.3)|
|Walter et al31||2016||Hot AXIOS||30||27 (90.0)||26 (86.7)||4 (13.3)||Not assessed|
|Kahaleh et al24||2016||cSEMS/AXIOS||35||32 (91.4)||31 (88.6)||8 (22.9)||Not assessed|
|Teoh et al5||2017||Hot AXIOS||59||57 (96.6)||53 (89.8)||19 (32.2)||1 (1.7)|
|Irani et al25||2017||Cold AXIOS/Hot AXIOS||45||44 (97.8)||43 (95.6)||5 (11.1)||11 (24.4)|
|Dollhopf et al23||2017||Hot AXIOS||75||74 (98.7)||72 (95.9)||8 (10.7)||Not assessed|
|Teoh et al26||2018||SPAXUS||17||15 (88.2)||16 (94.1)||0 (0)||Not assessed|
|Tyberg et al21||2018||AXIOS||42||40 (95.2)||40 (95.2)||9 (21.4)||4 (9.52)|
|Minaga et al27||2019||cSEMS/BONA-AL/plastic stent||21||19 (90.5)||17 (89.5)||3 (15.8)||0 (0)|
|James and Baron20||2019||AXIOS||15||14 (93.3)||14 (93.3)||2 (13.3)||Not assessed|
|Cho et al28||2020||BONA-AL/SPAXUS||71||69 (97.2)||69 (97.2)||6 (8.5)||Not assessed|
Values are presented as number (%)..
PT-GBD is recommended method for draining the gallbladder in patients that are at very high risk for cholecystectomy and suffering from AC.1 PT-GBD is associated with risk of adverse events such as blockade, dislodgement, skin infections and recurrent AC resulting in the need of repeated interventions. With the development of EUS-GBD, multiple studies compared the efficacy of EUS-GBD and PT-GBD as summarized in Table 2.5–7,21,25,29
Table 2 . Summary of Recent Publications Comparing the Outcomes between EUS-GBD and PT-GBD.
|Author||Year||No. of patients||Technical success||Clinical success||Adverse event||Repeat intervention|
|Jang et al29||2012||59||96.7 (||96.6 (||96.7 (||93.1 (||6.7 (||3.4 (||NA||NA|
|Kedia et al6||2015||73||100 (||97.6 (||86.7 (||97.6 (||13.3 (||39.5 (||NA||NA|
|Teoh et al5||2017||118||96.6 (||100 (||89.8 (||94.9 (||32.2 (||74.6 (||1.7 (||27.1 (|
|Irani et al25||2017||90||97.8 (||100 (||95.6 (||91.1 (||17.8 (||31.1 (||24.4 (||24.9 (|
|Tyberg et al21||2018||155||95.2 (||99.1 (||95.2 (||85.8 (||16.7 (||18.6 (||24 (||10 (|
|Teoh et al7||2020||80||97.4 (||100 (||92.3 (||92.5 (||25.6 (||77.5 (||2.6 (||50 (|
Values are presented as percentage (%)..
EUS-GBD, endoscopic ultrasonography-guided gallbladder drainage; PT-GBD, percutaneous transhepatic gallbladder drainage; NA, not assessed..
When comparing EUS-GBD and PT-GBD, most clinical studies demonstrated similar rates of technical (95%–100% vs 96.6%–100%) and clinical success (86.7%–100% vs 86%–100%, respectively). Whilst EUS-GBD has been shown to be associated with significantly lower rate of adverse events than PT-GBD (13.0%–32.2% vs 39.5%–77.5%,
The technique of ET-GBD requires expert endoscopy skills to insert the guidewire and stent through the curved and thin cystic duct. In a retrospective cohort study of 78 patients comparing the efficacy of EUS-GBD against ET-GBD, EUS-GBD has been found to have significantly higher clinical success rate than ET-GBD (95% vs 76.3%,
In an international multicentered retrospective study of 372 patients comparing the outcomes of the three procedure, EUS-GBD and PT-GBD have a significantly higher technical (94% vs 98% vs 88%) and clinical success rate (90% vs 97% vs 80%) than ET-GBD.35 EUS-GBD was also associated with less frequent late-term adverse events than the other two procedures (1.9% vs PT-GBD 19,8% vs ET-GBD 4.8%,
The efficacies between the three procedures have also been studied by a number of meta-analysis studies, Mohan et al36 summarized the results of 15,131 patients and the analysis showed that EUS-GBD is superior to ET-GBD while inferior to PT-GBD in terms of technical success rates while EUS-GBD is superior to both procedures in terms of clinical success rates.37 The complication rates have been found to be similar between the three procedures, complications include pancreatitis, bleeding, perforation and stent migrations, to name a few. The results of a network ranking meta-analysis agree with Mohan et al’s results36 on technical (EUS-GBD vs PT-GBD vs ET-GBD = 2.00 vs 1.02 vs 2.98) and clinical success rates (EUS-GBD vs PT-GBD vs ET-GBD = 1.48 vs 1.55 vs 2.98).37 Furthermore, this network meta-analysis has shown that the EUS-GBD has the lowest risk of recurrent cholecystitis, which is in line with the aforementioned studies. In addition, EUS-GBD has a lower risk of repeated intervention and readmission compared with PT-GBD while having a higher rate of such risks compared to ET-GBD. Interestingly, EUS-GBD has the highest risk of overall mortality among the three procedures (EUS- GBD vs PT-GBD vs ET-GBD = 2.62 vs 2.09 vs 1.29) despite homogeneity among the pooled groups. The results of Mohan et al’s meta-analysis36 also show similar results. Nonetheless, the results could be affected by numerous factors, for example, EUS-GBD has been employed with high-risk patients whose conditions have been worse. Hence, further research could be directed to evaluate the mortality rates between procedures and derive guidelines to reduce post-procedural mortalities.
EUS-GBD is currently indicated for patients at very high-risk for LC. Whether the approach is suitable for surgically fit patients is to be confirmed. A propensity score analysis matching patients for age, sex, and age-adjusted Charlson score compared the 1-year outcomes of EUS-GBD with LC.38 The technical success rates (100% vs 100%), clinical success rates (93.3% vs 100%,
In conclusion, EUS-GBD has been shown to be an effective means of achieving gallbladder drainage with superior efficacy to PT-GBD and ET-GBD in patients deemed at high-risk for LC. The procedure also creates portal for removing gallstones resulting in low rates of recurrent AC. Further studies are required to assess if the procedure is suitable in a selected group of surgically fit patients.
Professor Anthony Y.B. Teoh is a consultant for Boston Scientific, Cook, Taewoong and Microtech Medical Corporations.
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