- Email: [email protected]
Endoscopic ultrasound gallbladder drainage: Patient selection, preparation, and performance
Author’s Accepted Manuscript Endoscopic Ultrasound Gallbladder Drainage: Patient Selection, Preparation, and Performance A.J. Small, S. Irani
www.elsevier.com/locate/tgie
PII: DOI: Reference:
S1096-2883(17)30064-5 http://dx.doi.org/10.1016/j.tgie.2017.10.002 YTGIE50544
To appear in: Techniques in Gastrointestinal Endoscopy Cite this article as: A.J. Small and S. Irani, Endoscopic Ultrasound Gallbladder Drainage: Patient Selection, Preparation, and Performance, Techniques in Gastrointestinal Endoscopy, http://dx.doi.org/10.1016/j.tgie.2017.10.002 This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting galley proof before it is published in its final citable form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
1
Endoscopic Ultrasound Gallbladder Drainage: Patient Selection, Preparation, and Performance Small, AJ and Irani, S Division of Gastroenterology and Hepatology Virginia Mason Medical Center Correspondence: Shayan Irani, MBBS, Division of Gastroenterology and Hepatology, Virginia Mason Medical Center, 1100 Ninth Avenue, C3-GAS, Seattle, WA 98101 Email: [email protected] Fax: (206)-625-7195 Abstract: Acute cholecystitis is a common cause of hospital admissions and can result in critically ill patients. For those patients not amenable to cholecystectomy, endoscopic drainage via transpapillary cystic duct stenting or transmural drainage offers a temporizing method for urgent gallbladder decompression. Endoscopic ultrasonography (EUS) and the development of novel lumen apposing metal stents can allow for more permanent drainage with comparable outcomes to percutaneous transhepatic catheters. The merits of this approach including the technical and clinical advantages of EUS guided drainage are discussed further in this review article. Keywords: Acute cholecystitis, Interventional EUS, Transmural gallbladder drainage Abbreviations: PT-GBD, percutaneous transhepatic gallbladder drainage; EUS-GBD, endoscopic ultrasoundguided gallbladder drainage; CT, computed tomography; Fr, French; LAMS, lumen-apposing metal stent; SEMS, self-expandable metal stents
2
1. Introduction
The incidence of hospitalizations for acute cholecystitis in the United States is rising, and with it, the associated costs of hospital stays.1 Definitive treatment by surgical removal of the gallbladder is the gold standard. However, the mortality and morbidity for cholecystectomy in individuals with high risk comorbidities can be as high as 30 and 50% respectively.2 Prompt decompression of an obstructed gallbladder may be achieved by a percutaneous transhepatic gallbladder drain (PT-GBD) for candidates deemed unsuitable or high risk for cholecystectomy. Over the last three decades, endoscopic drainage of the gallbladder (transpapillary drainage via ERCP and transmural drainage via endoscopic ultrasound) has become an alternative option with several advantages over the percutaneous approach. More recently, internal decompression of the gallbladder facilitated under endoscopic guidance has rapidly evolved as a safe and effective option. This review focuses on the appropriate patient selection, preparation, and performance of endoscopic ultrasound gallbladder drainage (EUS-GBD) for treatment of cholecystitis. 2.
Patient Selection 2.1. The rationale for endoscopic internal drainage Acute cholecystitis can be secondary to benign (most commonly stones) or malignant disease
resulting in outflow obstruction of the cystic duct. Laparoscopic cholecystectomy remains the treatment of choice in most patients.3 However, surgery can be associated with increased risk of hemorrhage, bile leaks, and other intra-operative complications depending on the severity of gallbladder inflammation. Cholecystectomy is not always feasible in critically ill nor preferable in terminal patients.
For these and other high-risk operative candidates, conservative
management with intravenous fluids and antibiotics is recommended. For those refractory to
3
these conservative measures, nonsurgical decompression of the gallbladder is urgently needed to prevent sepsis, multi-organ dysfunction, a gangrenous or perforated gallbladder, and even death.4 Nonsurgical drainage by placement of a percutaneous transhepatic gallbladder drain (PT-GBD) has been described since the 1970s and may act as a bridge to elective cholecystectomy. While this approach can be technically easy to perform (percutaneous access to the gallbladder under transabdominal ultrasound or computed tomography (CT) and subsequent insertion of a 6 to 10 French (Fr) pigtail catheter drain), several patient conditions preclude PT-GBD such as ascites, intervening loops of intestine, or patients with coagulopathy or taking antiplatelet or antithrombotic medications. In addition, these external catheters have several disadvantages including the physical discomfort to the patient, a high frequency of dislodgement with rates to be reported to be as high as 31%, and the high overall costs and burden to the patients when follow-up sessions for revision or replacement are necessary. 5 Furthermore, percutaneous drains are typically placed as a temporizing measure until cholecystectomy can be performed; yet up to 37% of high-risk patients with cholecystostomy tubes placed with preoperative intent may require permanent placement.6 The chronic presence of an indwelling external catheter can lead to cellulitis, nerve impingement, peritonitis, and rarely, a non-healing choledochocutaneous fistula.3 Internal gallbladder drainage has become feasible through endoscopic means.4,7,8,9,10 There are two approaches. The first entails transpapillary drainage by endoscopic retrograde cholangiopancreatography (ERCP) stent placement across the cystic duct and neck of the gallbladder. The second entails a transmural approach under EUS visualization: the gallbladder is accessed from within the lumen of the gastrointestinal tract (most commonly the duodenum), a fistulous tract is created, and a stent is deployed. Whether the patient should first undergo ERCP
4
transpapillary or EUS transmural drainage is subject to current debate, and can depend on the patient’s anatomy (tortuosity, diameter, and degree of occlusion of the cystic duct), presence of ascites and intent of the procedure (preoperative or palliative).
Either method of internal
endoscopic drainage can obviate some of the problems encountered with emergent or urgent cholecystectomy and PT-GBD in select individuals. For the purposes of this review, the authors will focus on the merits and technical aspects of EUS-guided transmural intervention. 2.2. Indications and contraindications for EUS gallbladder drainage The optimal choice of drainage is dependent on both patient factors and provider or hospital capabilities. EUS gallbladder drainage requires a high level of expertise in advanced endoscopic techniques and familiarity with interventional endoscopic equipment and devices. Ultimately, the decision to proceed with EUS-GBD should include multiple disciplines including the involved surgeon’s input on the patient’s operative risk or candidacy. There are relative and absolute contraindications to cholecystectomy for cholecystitis (Table 1), for whom, EUS-GBD may be considered.11,12 Potential indications for EUS-GBD as of now includes: 1) palliative drainage in critically ill patients with severe comorbidities that preclude cholecystectomy (such as advanced malignancy or ASA ≥ III), 2) contraindication or refusal to undergo placement of a percutaneous drain. Contraindications to EUS-GBD include: 1) perforated gallbladder with biliary peritonitis; 2) inability to be sedated for endoscopy due to severe sepsis (Class 3 cholecystitis); 3) a potential surgical candidate down the road, which is a relative contraindication at this time.13,14 EUS-GBD as a bridge to elective cholecystectomy needs investigation and should probably not be performed yet, due to the creation of a large cholecystoenteric fistula that would require closure at the time of surgery, that could prolong or complicate the operation. In this
5
scenario, ERCP transpapillary stenting has the distinct advantage of allowing temporary drainage without the need to create a transmural fistulous tract. 2.3. Discussion of Risks and Benefits with Patients A discussion of the risks, benefits, and alternative treatment options are crucial when deciding to perform EUS guided gallbladder interventions. Patients and their families should be informed that this is a specialized therapeutic maneuver that, while often life-saving, also carries risk of adverse events. Several procedural-related early adverse events include puncture-induced hemorrhage, bile or air leakage (and resultant bile peritonitis or pneumoperitoneum), perforation, and stent migration into the gallbladder or intestinal lumen.4
Late adverse events include
delayed hemorrhage and relapsing cholecystitis following stent occlusion, albeit rare when using lumen apposing metal stents (LAMS). The timing of intervention depends on the severity of symptoms and the patient’s overall risk of decompensation if drainage is delayed.
Early
drainage (<7 days) using temporary cholecystostomy tubes have been associated with fewer complications at subsequent cholecystectomy and shorter hospitalizations.2 3.
Preparation and Performance 3.1. Preprocedural Planning and Execution Once the decision is made to perform EUS-GBD, there are several key procedural steps to
optimize the success of the technique. A review of available radiographic studies, i.e. CT scan of the abdomen, prior to the procedure can be informative of the best potential EUS access point to the gallbladder from the gastric or duodenal lumen. Furthermore, cross-sectional imaging taken in the right clinical picture can demonstrate a perforated gallbladder, and these patients should not undergo EUS-GBD. Next, the technique will vary depending on the chosen stent intended to
6
be placed. Transmural drainage can be performed using plastic stents, covered self-expandable metal stents (SEMS), and now most recently and probably exclusively, LAMS. Similar to EUS guided drainage of intra-abdominal fluid collections, the evolution of transmural gallbladder drainage began with the use of plastic nasocystic drains and double pigtail stents to the off-label use of SEMS to now the use of LAMS. There are several modified SEMS or LAMS that have a large diameter, short length, and flared ends to prevent the problems associated with straight biliary SEMS (bile leakage and migration). These include the partially covered BONA-AL stent (Standard Sci-Tech, Seoul, Korea), fully covered NAGI stent (Taewoong-Medical, Seoul, Korea) and the Axios stent (Boston Scientific, Natick, Ma, USA). Regardless of which stent is utilized, the initial step involves visualization of the gallbladder using the therapeutic linear echoendoscope often positioned in either the duodenal bulb or gastric antrum. The most suitable access point minimizes the distance between the gallbladder body or neck and the enteral lumen.
After excluding any intervening vessels using color Doppler
ultrasound, EUS cholecystoenterostomy can be performed in one of two ways depending on the method by which the fistulous tract will be formed, and the type of stent being deployed. 3.2. Technique with nasogallbladder drain, plastic stents, and SEMS After depiction of the gallbladder in close approximation with the antrum or duodenal bulb, a 19-gauge needle is used to puncture the gallbladder.
Bile can be aspirated and/or a
cholecystogram can be obtained to confirm positioning within the gallbladder. Next, a guidewire can be passed through the needle and coiled within the gallbladder. Small diameter bougie (6 or 7 Fr) and balloon (4 mm) dilators have been reported to sequentially dilate the tract over the guidewire. Alternately, an over-the-wire triple lumen needle knife or cystotome (6 or 10 Fr) can
7
be used to access the gallbladder. Following tract dilation, a nasogallbladder drain, double pigtail plastic stent, or conventional covered SEMS can be inserted over the guidewire. 3.3. Technique with LAMS The recent availability of a LAMS (Axios) has streamlined EUS-GBD. While initially designed and FDA approved for drainage of peri-pancreatic fluid collections, LAMS allows for effective gallbladder drainage as well. This modified SEMS is a fully covered Nitinol braided stent with bilateral anchor flanges that is 10 mm in length with an inner diameter of 10 or 15 mm, and outer flange of 21 or 24 mm diameter. While either 10 or 15 mm inner diameter stents can be used for gallbladder drainage, and both have been reported in the literature, the smaller diameter 10 mm stents may be preferable for trans-duodenal placement where the working space in the duodenal bulb may be limited. Furthermore, food can become entrapped within the stent and gallbladder, and as such a smaller diameter stent maybe less likely to cause this. This is also why we routinely place a plastic pigtail stent though the LAMS at our institution. On the other hand, certain situations may require more expeditious drainage such as the presence of gallstones greater than 1 cm, and thus, the use of the larger diameter 15 mm waist offers advantage. The dumbbell shaped flanges function to anchor the two targeted lumens and allow apposition of the gallbladder wall to the duodenum or stomach. As such, the distance between the gallbladder and stomach or duodenum should be minimized, and no more than the length of the LAMS saddle i.e. 10 mm. The non-cautery enhanced LAMS required dilation steps as described above. The more recently introduced cautery-enhanced LAMS is a 10.5 Fr catheter based delivery system that has been adapted such that the cautery-enhanced tip facilitates placement with or without a guidewire in place.
The cautery-enhanced LAMS is recommended to be connected to an
electrosurgical unit that applies monopolar energy using a pure cut mode ranging from 80 to 120
8
Watts. ERBE generators (ERBE, Inc., Marietta, GA, USA) are compatible with the Axios delivery system, programmed to Auto Cut, Effect 5, Max Watts 100 in our endoscopy unit. Once the distal flange is in the gallbladder lumen, it is unsheathed under EUS visualization. The distal flange is then pulled back to create proximal traction on gallbladder wall and appose the lumen of the duodenal or gastric wall. The proximal flange is then deployed under direct endoscopic visualization or under EUS-guidance alone. Finally, some physicians (we routinely do at our institution) deploy a double pigtail through the LAMS to anecdotally prevent tissue hyperplasia that can result in delayed metal stent occlusion at the uncovered flanges. This stepwise approach for placement of a cautery-enhanced LAMS is further illustrated in Figure 1. 4. Outcomes after EUS-GBD The feasibility of internal gallbladder drainage for cholecystitis by transpapillary cystic duct stenting was initially demonstrated over thirty years ago.8,15,16 Since that time, the application of EUS transmural drainage of inflamed and/or infected intra-abdominal collections has extended to include the gallbladder, and been validated in several studies.3,9,17,18,19,20,21,22,23
The technical
and clinical successes of EUS-GBD have been validated in several pooled analyses.24,25,26 When combining all stent types (plastic, SEMS, and LAMS), EUS-GBD has a technical success rate of 97% and clinical success rate of 99% in immediate resolution of acute cholecystitis, with an adverse event rate of 8%.23 Nevertheless, plastic stents have fallen out of favor in light of larger diameter SEMS that are less apt to occlude over time, and even more so, after the development of LAMS with their anti-migratory properties, wide diameter, and low frequency of bile leakage. EUS-GBD may offer a more suitable nonsurgical method of gallbladder decompression as compared to time-honored percutaneous transhepatic drains. Indeed, a few landmark studies have demonstrated that EUS transmural drainage can achieve similar technical and clinical
9
success compared with PT-GBD.27,28,29,30,31 In a randomized clinical trial comparing EUS-GBD using nasobiliary tubes and PT-GBD, both techniques were comparable in terms of technical and clinical response rates exceeding 90% (based on post-procedural symptoms and laboratory values), with similar safety profiles (adverse events EUS-GBD 7% vs. PT-GBD 3%; P>0.05).26 When comparing PT-GBD to EUS-GBD with LAMS, patients treated by transmural drainage had the added benefit of reduced post-procedural pain. The EUS-GBD cohort had a shorter hospital stay, fewer repeated interventions (and thus less risk of recurrent cholecystitis), and a trend toward fewer adverse events than those patients who underwent PT-GBD.27
In this
multicenter, international study and other case series, high technical success rates (up to 98%) and clinical success rates (up to 96%) were achieved using LAMS for treatment of cholecystitis.27,28,32
Immediate resolution of acute cholecystitis can be achieved without
recurrence and with minimal adverse events, although studies with longitudinal follow-up are lacking. A few studies with medium term follow-up (up to one year without LAMS removal) have demonstrated promising low rates of major adverse events including negligible stent migration rates.27,31,33 Taken together, EUS guided gallbladder interventions may someday replace the need for cholecystostomy tubes in high-risk inoperable candidates. 5. Conclusion Over the years, new endoscopic techniques and tools have facilitated new interventions applicable to gallbladder disorders. The development of EUS-guided gallbladder drainage has become a viable option for patients with cholecystitis who are critically ill and poor operative candidates. Moreover, LAMS technology permits drainage of an inflamed gallbladder either as primary therapy or as a secondary treatment to internalize cholecystostomy tubes. Additional investigations including randomized controlled trials comparing ERCP transpapillary drainage to
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EUS-GBD and PT-GBD will provide insight on the optimal nonsurgical therapies as the field of interventional EUS continues to expand. Acknowledgements: None. Conflict of interest statement: Aaron Small is a consultant for Boston Scientific. Shayan Irani is a consultant for Boston Scientific, with remittance to clinic. REFERENCES 1
Wadhwa V, Jobanputra Y, Garg SK, et al. Nationwide trends of hospital admissions for acute cholecystitis in the United States. Gastroenterol Rep (Oxf). 2016 May 11. [Epub ahead of print]. 2
Frazee RC, Nagorney DM, Mucha P Jr. Acute acalculous cholecystitis. Mayo Clin Proc. 1989; 64:163-7. 3
Baron TH, Grimm IS, Swanstrom LL. Interventional Approaches to Gallbladder Disease. N Engl J Med. 2015; 373:357-65. 4
Hasan MK, Itoi T, Varadarajulu S. Endoscopic management of acute cholecystitis. Gastrointest Endosc Clin N Am. 2013; 23:453-9. 5
Bagla P, Sarria JC, Riall TS. Management of acute cholecystitis. Curr Opin Infect Dis. 2016; 29:508-13. 6
Mizrahi I, Mazeh H, Yuval JB, et al. Perioperative outcomes of delayed laparoscopic cholecystectomy for acute calculous cholecystitis with and without percutaneous cholecystostomy. Surgery. 2015; 158:728-35. 7
Irani S, Baron TH, Grimm IS, et al. EUS-guided gallbladder drainage with a lumen-apposing metal stent (with video). Gastrointest Endosc. 2015; 82:1110-5. 8
Itoi T, Coelho-Prabhu N, Baron TH. Endoscopic gallbladder drainage for management of acute cholecystitis. Gastrointest Endosc. 2010; 71:1038-45. 9
Law R, Baron TH. Endoscopic ultrasound-guided biliary interventions: an update on recent developments. Curr Opin Gastroenterol. 2016; 32:232-7. 10
Pannala R, Petersen BT, Gostout CJ, et al. Endoscopic transpapillary gallbladder drainage: 10-year single center experience. Minerva Gastroenterol Dietol. 2008; 54:107-13.
11
11
Keus F, Broeders IA, van Laarhoven CJ. Gallstone disease: Surgical aspects of symptomatic cholecystolithiasis and acute cholecystitis. Best Pract Res Clin Gastroenterol. 2006; 20:1031-51. 12
Steinert R, Nestler G, Sagynaliev E, et al. Laparoscopic cholecystectomy and gallbladder cancer. J Surg Oncol. 2006; 93:682-9. 13
Choi JH, Lee SS. Endoscopic ultrasonography-guided gallbladder drainage for acute cholecystitis: from evidence to practice. Dig Endosc. 2015; 27:1-7. 14
Hirota M, Takada T, Kawarada Y, et al. Diagnostic criteria and severity assessment of acute cholecystitis: Tokyo Guidelines. J Hepatobiliary Pancreat Surg. 2007; 14:78-82. 15
Kozarek RA. Selective cannulation of the cystic duct at time of ERCP. J Clin Gastroenterol. 1984; 6:37-40. 16
Feretis C, Apostolidis N, Mallas E, et al. Endoscopic drainage of acute obstructive cholecystitis in patients with increased operative risk. Endoscopy. 1993; 25:392-5. 17
Baron TH, Topazian MD. Endoscopic transduodenal drainage of the gallbladder: implications for endoluminal treatment of gallbladder disease. Gastrointest Endosc. 2007; 65:735-7. 18
Itoi T, Itokawa F, Kurihara T. Endoscopic ultrasonography-guided gallbladder drainage: actual technical presentations and review of the literature (with videos). J Hepatobiliary Pancreat Sci. 2011; 18:282-6. 19
Widmer J, Alvarez P, Sharaiha RZ, et al. Endoscopic Gallbladder Drainage for Acute Cholecystitis. Clin Endosc. 2015; 48:411-20. 20
Kahaleh M, Perez-Miranda M, Artifon EL, et al. International collaborative study on EUSguided gallbladder drainage: Are we ready for prime time? Dig Liver Dis. 2016; 48:1054-7. 21
Song TJ, Park DH, Eum JB, et al. EUS-guided cholecystoenterostomy with single-step placement of a 7F double-pigtail plastic stent in patients who are unsuitable for cholecystectomy: a pilot study (with video). Gastrointest Endosc. 2010; 71:634-40. 22
Lee SS, Park DH, Hwang CY, et al. EUS-guided transmural cholecystostomy as rescue management for acute cholecystitis in elderly or high-risk patients: a prospective feasibility study. Gastrointest Endosc. 2007; 66:1008-12. 23
Jang JW, Lee SS, Park DH, et al. Feasibility and safety of EUS-guided transgastric/transduodenal gallbladder drainage with single-step placement of a modified covered self-expandable metal stent in patients unsuitable for cholecystectomy. Gastrointest Endosc. 2011; 74:176-81.
12
24
Peñas-Herrero I, de la Serna-Higuera C, Perez-Miranda M. Endoscopic ultrasound-guided gallbladder drainage for the management of acute cholecystitis (with video). J Hepatobiliary Pancreat Sci. 2015; 22:35-43. 25
Widmer J, Singhal S, Gaidhane M, et al. Endoscopic ultrasound-guided endoluminal drainage of the gallbladder. Dig Endosc. 2014; 26:525-31. 26
Anderloni A, Buda A, Vieceli F, et al. Endoscopic ultrasound guided transmural stenting for gallbladder drainage in high-risk patients with acute cholecystitis: a systematic review and pooled analysis. Surg Endosc. 2016; 30:5200-08. 27
Jang JW, Lee SS, Song TJ, et al. Endoscopic ultrasound-guided transmural and percutaneous transhepatic gallbladder drainage are comparable for acute cholecystitis. Gastroenterology. 2012; 142:805-11. 28
Irani S, Ngamruengphong S, Teoh A, et al. Similar Efficacies of Endoscopic Ultrasound Gallbladder Drainage With a Lumen-Apposing Metal Stent Versus Percutaneous Transhepatic Gallbladder Drainage for Acute Cholecystitis. Clin Gastroenterol Hepatol. 2017;15:738-745. 29
Tyberg A, Saumoy M, Sequeiros EV, et al. EUS-guided Versus Percutaneous Gallbladder Drainage: Isn't It Time to Convert? J Clin Gastroenterol. 2016 Dec 22. [Epub ahead of print]. 30
Teoh AYB, Serna C, Penas I, et al. Endoscopic ultrasound-guided gallbladder drainage reduces adverse events compared with percutaneous cholecystostomy in patients who are unfit for cholecystectomy. Endoscopy. 2017; 49:130-138. 31
Choi JH, Kim HW, Lee JC, et al. Percutaneous transhepatic versus EUS-guided gallbladder drainage for malignant cystic duct obstruction. Gastrointest Endosc. 2017; 85:357-364. 32
Walter D, Teoh AY, Itoi T, et al. EUS-guided gall bladder drainage with a lumen-apposing metal stent: a prospective long-term evaluation. Gut. 2016; 65:6-8. 33
Inoue T, Okumura F, Kachi K, et al. Long-term outcomes of endoscopic gallbladder stenting in high-risk surgical patients with calculous cholecystitis (with videos). Gastrointest Endosc. 2016; 83:905-13.
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Figure 1. EUS guided gallbladder drainage using LAMS A. EUS visualization of the gallbladder in close approximation with the duodenal bulb B. Cautery-enhanced catheter tip positioned for entry into the gallbladder (EUS and fluoroscopic views) C. Distal flange unsheathed in the gallbladder lumen after transmural insertion of the LAMS catheter D. Fluoroscopic view of a fully deployed LAMS following deployment of the proximal flange in the duodenal lumen E. Endoscopic view of pus draining from the gallbladder after successful LAMS placement F. Placement of a plastic pigtail stent through LAMS
14
15
16
17
Table 1. Contraindications to Cholecystectomy for Acute Cholecystitis Absolute
Peritonitis with hemodynamic compromise
Refractory coagulopathy
Inability to tolerate general anesthesia
Gallbladder cancer
Relative Contraindications*
*
Prior extensive abdominal surgeries
Active cholangitis
Cirrhosis with portal hypertension
Severe cardiopulmonary disease
Morbid obesity
Pregnancy
Dependent on the surgeon’s experience and judgement
www.elsevier.com/locate/tgie
PII: DOI: Reference:
S1096-2883(17)30064-5 http://dx.doi.org/10.1016/j.tgie.2017.10.002 YTGIE50544
To appear in: Techniques in Gastrointestinal Endoscopy Cite this article as: A.J. Small and S. Irani, Endoscopic Ultrasound Gallbladder Drainage: Patient Selection, Preparation, and Performance, Techniques in Gastrointestinal Endoscopy, http://dx.doi.org/10.1016/j.tgie.2017.10.002 This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting galley proof before it is published in its final citable form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
1
Endoscopic Ultrasound Gallbladder Drainage: Patient Selection, Preparation, and Performance Small, AJ and Irani, S Division of Gastroenterology and Hepatology Virginia Mason Medical Center Correspondence: Shayan Irani, MBBS, Division of Gastroenterology and Hepatology, Virginia Mason Medical Center, 1100 Ninth Avenue, C3-GAS, Seattle, WA 98101 Email: [email protected] Fax: (206)-625-7195 Abstract: Acute cholecystitis is a common cause of hospital admissions and can result in critically ill patients. For those patients not amenable to cholecystectomy, endoscopic drainage via transpapillary cystic duct stenting or transmural drainage offers a temporizing method for urgent gallbladder decompression. Endoscopic ultrasonography (EUS) and the development of novel lumen apposing metal stents can allow for more permanent drainage with comparable outcomes to percutaneous transhepatic catheters. The merits of this approach including the technical and clinical advantages of EUS guided drainage are discussed further in this review article. Keywords: Acute cholecystitis, Interventional EUS, Transmural gallbladder drainage Abbreviations: PT-GBD, percutaneous transhepatic gallbladder drainage; EUS-GBD, endoscopic ultrasoundguided gallbladder drainage; CT, computed tomography; Fr, French; LAMS, lumen-apposing metal stent; SEMS, self-expandable metal stents
2
1. Introduction
The incidence of hospitalizations for acute cholecystitis in the United States is rising, and with it, the associated costs of hospital stays.1 Definitive treatment by surgical removal of the gallbladder is the gold standard. However, the mortality and morbidity for cholecystectomy in individuals with high risk comorbidities can be as high as 30 and 50% respectively.2 Prompt decompression of an obstructed gallbladder may be achieved by a percutaneous transhepatic gallbladder drain (PT-GBD) for candidates deemed unsuitable or high risk for cholecystectomy. Over the last three decades, endoscopic drainage of the gallbladder (transpapillary drainage via ERCP and transmural drainage via endoscopic ultrasound) has become an alternative option with several advantages over the percutaneous approach. More recently, internal decompression of the gallbladder facilitated under endoscopic guidance has rapidly evolved as a safe and effective option. This review focuses on the appropriate patient selection, preparation, and performance of endoscopic ultrasound gallbladder drainage (EUS-GBD) for treatment of cholecystitis. 2.
Patient Selection 2.1. The rationale for endoscopic internal drainage Acute cholecystitis can be secondary to benign (most commonly stones) or malignant disease
resulting in outflow obstruction of the cystic duct. Laparoscopic cholecystectomy remains the treatment of choice in most patients.3 However, surgery can be associated with increased risk of hemorrhage, bile leaks, and other intra-operative complications depending on the severity of gallbladder inflammation. Cholecystectomy is not always feasible in critically ill nor preferable in terminal patients.
For these and other high-risk operative candidates, conservative
management with intravenous fluids and antibiotics is recommended. For those refractory to
3
these conservative measures, nonsurgical decompression of the gallbladder is urgently needed to prevent sepsis, multi-organ dysfunction, a gangrenous or perforated gallbladder, and even death.4 Nonsurgical drainage by placement of a percutaneous transhepatic gallbladder drain (PT-GBD) has been described since the 1970s and may act as a bridge to elective cholecystectomy. While this approach can be technically easy to perform (percutaneous access to the gallbladder under transabdominal ultrasound or computed tomography (CT) and subsequent insertion of a 6 to 10 French (Fr) pigtail catheter drain), several patient conditions preclude PT-GBD such as ascites, intervening loops of intestine, or patients with coagulopathy or taking antiplatelet or antithrombotic medications. In addition, these external catheters have several disadvantages including the physical discomfort to the patient, a high frequency of dislodgement with rates to be reported to be as high as 31%, and the high overall costs and burden to the patients when follow-up sessions for revision or replacement are necessary. 5 Furthermore, percutaneous drains are typically placed as a temporizing measure until cholecystectomy can be performed; yet up to 37% of high-risk patients with cholecystostomy tubes placed with preoperative intent may require permanent placement.6 The chronic presence of an indwelling external catheter can lead to cellulitis, nerve impingement, peritonitis, and rarely, a non-healing choledochocutaneous fistula.3 Internal gallbladder drainage has become feasible through endoscopic means.4,7,8,9,10 There are two approaches. The first entails transpapillary drainage by endoscopic retrograde cholangiopancreatography (ERCP) stent placement across the cystic duct and neck of the gallbladder. The second entails a transmural approach under EUS visualization: the gallbladder is accessed from within the lumen of the gastrointestinal tract (most commonly the duodenum), a fistulous tract is created, and a stent is deployed. Whether the patient should first undergo ERCP
4
transpapillary or EUS transmural drainage is subject to current debate, and can depend on the patient’s anatomy (tortuosity, diameter, and degree of occlusion of the cystic duct), presence of ascites and intent of the procedure (preoperative or palliative).
Either method of internal
endoscopic drainage can obviate some of the problems encountered with emergent or urgent cholecystectomy and PT-GBD in select individuals. For the purposes of this review, the authors will focus on the merits and technical aspects of EUS-guided transmural intervention. 2.2. Indications and contraindications for EUS gallbladder drainage The optimal choice of drainage is dependent on both patient factors and provider or hospital capabilities. EUS gallbladder drainage requires a high level of expertise in advanced endoscopic techniques and familiarity with interventional endoscopic equipment and devices. Ultimately, the decision to proceed with EUS-GBD should include multiple disciplines including the involved surgeon’s input on the patient’s operative risk or candidacy. There are relative and absolute contraindications to cholecystectomy for cholecystitis (Table 1), for whom, EUS-GBD may be considered.11,12 Potential indications for EUS-GBD as of now includes: 1) palliative drainage in critically ill patients with severe comorbidities that preclude cholecystectomy (such as advanced malignancy or ASA ≥ III), 2) contraindication or refusal to undergo placement of a percutaneous drain. Contraindications to EUS-GBD include: 1) perforated gallbladder with biliary peritonitis; 2) inability to be sedated for endoscopy due to severe sepsis (Class 3 cholecystitis); 3) a potential surgical candidate down the road, which is a relative contraindication at this time.13,14 EUS-GBD as a bridge to elective cholecystectomy needs investigation and should probably not be performed yet, due to the creation of a large cholecystoenteric fistula that would require closure at the time of surgery, that could prolong or complicate the operation. In this
5
scenario, ERCP transpapillary stenting has the distinct advantage of allowing temporary drainage without the need to create a transmural fistulous tract. 2.3. Discussion of Risks and Benefits with Patients A discussion of the risks, benefits, and alternative treatment options are crucial when deciding to perform EUS guided gallbladder interventions. Patients and their families should be informed that this is a specialized therapeutic maneuver that, while often life-saving, also carries risk of adverse events. Several procedural-related early adverse events include puncture-induced hemorrhage, bile or air leakage (and resultant bile peritonitis or pneumoperitoneum), perforation, and stent migration into the gallbladder or intestinal lumen.4
Late adverse events include
delayed hemorrhage and relapsing cholecystitis following stent occlusion, albeit rare when using lumen apposing metal stents (LAMS). The timing of intervention depends on the severity of symptoms and the patient’s overall risk of decompensation if drainage is delayed.
Early
drainage (<7 days) using temporary cholecystostomy tubes have been associated with fewer complications at subsequent cholecystectomy and shorter hospitalizations.2 3.
Preparation and Performance 3.1. Preprocedural Planning and Execution Once the decision is made to perform EUS-GBD, there are several key procedural steps to
optimize the success of the technique. A review of available radiographic studies, i.e. CT scan of the abdomen, prior to the procedure can be informative of the best potential EUS access point to the gallbladder from the gastric or duodenal lumen. Furthermore, cross-sectional imaging taken in the right clinical picture can demonstrate a perforated gallbladder, and these patients should not undergo EUS-GBD. Next, the technique will vary depending on the chosen stent intended to
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be placed. Transmural drainage can be performed using plastic stents, covered self-expandable metal stents (SEMS), and now most recently and probably exclusively, LAMS. Similar to EUS guided drainage of intra-abdominal fluid collections, the evolution of transmural gallbladder drainage began with the use of plastic nasocystic drains and double pigtail stents to the off-label use of SEMS to now the use of LAMS. There are several modified SEMS or LAMS that have a large diameter, short length, and flared ends to prevent the problems associated with straight biliary SEMS (bile leakage and migration). These include the partially covered BONA-AL stent (Standard Sci-Tech, Seoul, Korea), fully covered NAGI stent (Taewoong-Medical, Seoul, Korea) and the Axios stent (Boston Scientific, Natick, Ma, USA). Regardless of which stent is utilized, the initial step involves visualization of the gallbladder using the therapeutic linear echoendoscope often positioned in either the duodenal bulb or gastric antrum. The most suitable access point minimizes the distance between the gallbladder body or neck and the enteral lumen.
After excluding any intervening vessels using color Doppler
ultrasound, EUS cholecystoenterostomy can be performed in one of two ways depending on the method by which the fistulous tract will be formed, and the type of stent being deployed. 3.2. Technique with nasogallbladder drain, plastic stents, and SEMS After depiction of the gallbladder in close approximation with the antrum or duodenal bulb, a 19-gauge needle is used to puncture the gallbladder.
Bile can be aspirated and/or a
cholecystogram can be obtained to confirm positioning within the gallbladder. Next, a guidewire can be passed through the needle and coiled within the gallbladder. Small diameter bougie (6 or 7 Fr) and balloon (4 mm) dilators have been reported to sequentially dilate the tract over the guidewire. Alternately, an over-the-wire triple lumen needle knife or cystotome (6 or 10 Fr) can
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be used to access the gallbladder. Following tract dilation, a nasogallbladder drain, double pigtail plastic stent, or conventional covered SEMS can be inserted over the guidewire. 3.3. Technique with LAMS The recent availability of a LAMS (Axios) has streamlined EUS-GBD. While initially designed and FDA approved for drainage of peri-pancreatic fluid collections, LAMS allows for effective gallbladder drainage as well. This modified SEMS is a fully covered Nitinol braided stent with bilateral anchor flanges that is 10 mm in length with an inner diameter of 10 or 15 mm, and outer flange of 21 or 24 mm diameter. While either 10 or 15 mm inner diameter stents can be used for gallbladder drainage, and both have been reported in the literature, the smaller diameter 10 mm stents may be preferable for trans-duodenal placement where the working space in the duodenal bulb may be limited. Furthermore, food can become entrapped within the stent and gallbladder, and as such a smaller diameter stent maybe less likely to cause this. This is also why we routinely place a plastic pigtail stent though the LAMS at our institution. On the other hand, certain situations may require more expeditious drainage such as the presence of gallstones greater than 1 cm, and thus, the use of the larger diameter 15 mm waist offers advantage. The dumbbell shaped flanges function to anchor the two targeted lumens and allow apposition of the gallbladder wall to the duodenum or stomach. As such, the distance between the gallbladder and stomach or duodenum should be minimized, and no more than the length of the LAMS saddle i.e. 10 mm. The non-cautery enhanced LAMS required dilation steps as described above. The more recently introduced cautery-enhanced LAMS is a 10.5 Fr catheter based delivery system that has been adapted such that the cautery-enhanced tip facilitates placement with or without a guidewire in place.
The cautery-enhanced LAMS is recommended to be connected to an
electrosurgical unit that applies monopolar energy using a pure cut mode ranging from 80 to 120
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Watts. ERBE generators (ERBE, Inc., Marietta, GA, USA) are compatible with the Axios delivery system, programmed to Auto Cut, Effect 5, Max Watts 100 in our endoscopy unit. Once the distal flange is in the gallbladder lumen, it is unsheathed under EUS visualization. The distal flange is then pulled back to create proximal traction on gallbladder wall and appose the lumen of the duodenal or gastric wall. The proximal flange is then deployed under direct endoscopic visualization or under EUS-guidance alone. Finally, some physicians (we routinely do at our institution) deploy a double pigtail through the LAMS to anecdotally prevent tissue hyperplasia that can result in delayed metal stent occlusion at the uncovered flanges. This stepwise approach for placement of a cautery-enhanced LAMS is further illustrated in Figure 1. 4. Outcomes after EUS-GBD The feasibility of internal gallbladder drainage for cholecystitis by transpapillary cystic duct stenting was initially demonstrated over thirty years ago.8,15,16 Since that time, the application of EUS transmural drainage of inflamed and/or infected intra-abdominal collections has extended to include the gallbladder, and been validated in several studies.3,9,17,18,19,20,21,22,23
The technical
and clinical successes of EUS-GBD have been validated in several pooled analyses.24,25,26 When combining all stent types (plastic, SEMS, and LAMS), EUS-GBD has a technical success rate of 97% and clinical success rate of 99% in immediate resolution of acute cholecystitis, with an adverse event rate of 8%.23 Nevertheless, plastic stents have fallen out of favor in light of larger diameter SEMS that are less apt to occlude over time, and even more so, after the development of LAMS with their anti-migratory properties, wide diameter, and low frequency of bile leakage. EUS-GBD may offer a more suitable nonsurgical method of gallbladder decompression as compared to time-honored percutaneous transhepatic drains. Indeed, a few landmark studies have demonstrated that EUS transmural drainage can achieve similar technical and clinical
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success compared with PT-GBD.27,28,29,30,31 In a randomized clinical trial comparing EUS-GBD using nasobiliary tubes and PT-GBD, both techniques were comparable in terms of technical and clinical response rates exceeding 90% (based on post-procedural symptoms and laboratory values), with similar safety profiles (adverse events EUS-GBD 7% vs. PT-GBD 3%; P>0.05).26 When comparing PT-GBD to EUS-GBD with LAMS, patients treated by transmural drainage had the added benefit of reduced post-procedural pain. The EUS-GBD cohort had a shorter hospital stay, fewer repeated interventions (and thus less risk of recurrent cholecystitis), and a trend toward fewer adverse events than those patients who underwent PT-GBD.27
In this
multicenter, international study and other case series, high technical success rates (up to 98%) and clinical success rates (up to 96%) were achieved using LAMS for treatment of cholecystitis.27,28,32
Immediate resolution of acute cholecystitis can be achieved without
recurrence and with minimal adverse events, although studies with longitudinal follow-up are lacking. A few studies with medium term follow-up (up to one year without LAMS removal) have demonstrated promising low rates of major adverse events including negligible stent migration rates.27,31,33 Taken together, EUS guided gallbladder interventions may someday replace the need for cholecystostomy tubes in high-risk inoperable candidates. 5. Conclusion Over the years, new endoscopic techniques and tools have facilitated new interventions applicable to gallbladder disorders. The development of EUS-guided gallbladder drainage has become a viable option for patients with cholecystitis who are critically ill and poor operative candidates. Moreover, LAMS technology permits drainage of an inflamed gallbladder either as primary therapy or as a secondary treatment to internalize cholecystostomy tubes. Additional investigations including randomized controlled trials comparing ERCP transpapillary drainage to
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EUS-GBD and PT-GBD will provide insight on the optimal nonsurgical therapies as the field of interventional EUS continues to expand. Acknowledgements: None. Conflict of interest statement: Aaron Small is a consultant for Boston Scientific. Shayan Irani is a consultant for Boston Scientific, with remittance to clinic. REFERENCES 1
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Baron TH, Grimm IS, Swanstrom LL. Interventional Approaches to Gallbladder Disease. N Engl J Med. 2015; 373:357-65. 4
Hasan MK, Itoi T, Varadarajulu S. Endoscopic management of acute cholecystitis. Gastrointest Endosc Clin N Am. 2013; 23:453-9. 5
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Kahaleh M, Perez-Miranda M, Artifon EL, et al. International collaborative study on EUSguided gallbladder drainage: Are we ready for prime time? Dig Liver Dis. 2016; 48:1054-7. 21
Song TJ, Park DH, Eum JB, et al. EUS-guided cholecystoenterostomy with single-step placement of a 7F double-pigtail plastic stent in patients who are unsuitable for cholecystectomy: a pilot study (with video). Gastrointest Endosc. 2010; 71:634-40. 22
Lee SS, Park DH, Hwang CY, et al. EUS-guided transmural cholecystostomy as rescue management for acute cholecystitis in elderly or high-risk patients: a prospective feasibility study. Gastrointest Endosc. 2007; 66:1008-12. 23
Jang JW, Lee SS, Park DH, et al. Feasibility and safety of EUS-guided transgastric/transduodenal gallbladder drainage with single-step placement of a modified covered self-expandable metal stent in patients unsuitable for cholecystectomy. Gastrointest Endosc. 2011; 74:176-81.
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Peñas-Herrero I, de la Serna-Higuera C, Perez-Miranda M. Endoscopic ultrasound-guided gallbladder drainage for the management of acute cholecystitis (with video). J Hepatobiliary Pancreat Sci. 2015; 22:35-43. 25
Widmer J, Singhal S, Gaidhane M, et al. Endoscopic ultrasound-guided endoluminal drainage of the gallbladder. Dig Endosc. 2014; 26:525-31. 26
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Jang JW, Lee SS, Song TJ, et al. Endoscopic ultrasound-guided transmural and percutaneous transhepatic gallbladder drainage are comparable for acute cholecystitis. Gastroenterology. 2012; 142:805-11. 28
Irani S, Ngamruengphong S, Teoh A, et al. Similar Efficacies of Endoscopic Ultrasound Gallbladder Drainage With a Lumen-Apposing Metal Stent Versus Percutaneous Transhepatic Gallbladder Drainage for Acute Cholecystitis. Clin Gastroenterol Hepatol. 2017;15:738-745. 29
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Figure 1. EUS guided gallbladder drainage using LAMS A. EUS visualization of the gallbladder in close approximation with the duodenal bulb B. Cautery-enhanced catheter tip positioned for entry into the gallbladder (EUS and fluoroscopic views) C. Distal flange unsheathed in the gallbladder lumen after transmural insertion of the LAMS catheter D. Fluoroscopic view of a fully deployed LAMS following deployment of the proximal flange in the duodenal lumen E. Endoscopic view of pus draining from the gallbladder after successful LAMS placement F. Placement of a plastic pigtail stent through LAMS
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Table 1. Contraindications to Cholecystectomy for Acute Cholecystitis Absolute
Peritonitis with hemodynamic compromise
Refractory coagulopathy
Inability to tolerate general anesthesia
Gallbladder cancer
Relative Contraindications*
*
Prior extensive abdominal surgeries
Active cholangitis
Cirrhosis with portal hypertension
Severe cardiopulmonary disease
Morbid obesity
Pregnancy
Dependent on the surgeon’s experience and judgement