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DOI: 10.1055/a-2509-7076
EUS-guided gallbladder drainage vs dual stent transpapillary gallbladder drainage for management of acute cholecystitis
Abstract
Background and study aims
Cholecystectomy (CCY) is the standard treatment for acute cholecystitis. For non-surgical patients, percutaneous cholecystostomy tube (PT-GBD) is recommended but is associated with high readmission rates and poor quality of life. Endoscopic gallbladder decompression techniques, including endoscopic transpapillary gallbladder drainage (ET-GBD) and endoscopic ultrasound-guided gallbladder drainage (EUS-GBD), are alternatives. Studies comparing ET-GBD and EUS-GBD have shown EUS-GBD to have superior outcomes. However, these studies assessed ET-GBD mostly via single transcystic stent placement (SSET-GBD). This study aimed to compare outcomes of dual transcystic stents (DSET-GBD) and EUS-GBD in non-surgical candidates with acute cholecystitis.
Patients and methods
A multicenter analysis was conducted on patients who underwent ET-GBD or EUS-GBD between January 2019 and January 2023. Data were extracted from electronic medical records and outcomes including technical success, success, adverse events (AEs), and recurrence rates of cholecystitis were measured.
Results
Of 129 procedures (56 EUS-GBD; 73 ET-GBD), technical success was achieved in 87.5% of EUS-GBD and 86.3% of ET-GBD attempts. Immediate clinical success was achieved in 98.1% for EUS-GBD and 100% for DSET-GBD. AE rates were similar between the groups. Recurrent cholecystitis rates were 5.3% for EUS-GBD and 8.2% for DSET-GBD (P = 0.692).
Conclusions
This study demonstrates that DSET-GBD has similarly low rates of recurrent acute cholecystitis compared with EUS-GBD. DSET-GBD should be considered as an alternative management strategy for management of acute cholecystitis in patients who are unable to undergo CCY.
Introduction
Laparoscopic cholecystectomy (CCY) is the standard-of-care approach for patients with acute cholecystitis. The 2018 Tokyo guidelines recommend gallbladder decompression via percutaneous cholecystostomy tube (PT-GBD) as second-line therapy for non-surgical patients with acute cholecystitis (AC) [1]. Incidence of acute cholecystitis is increasing, as is the proportion of patients undergoing PT-GBD for management of acute cholecystitis, in part because of an aging population with a greater prevalence of comorbidities [2]. PT-GBD has previously been a favorable option because it can be performed at the bedside without sedation and is available in both academic and community hospitals; however, PT-GBD is associated with diminished quality of life and an increased reintervention rate due to several associated issues, including tube occlusion or migration [1] [2]. Recent data show that patients who undergo PT-GBD have a 50% readmission rate, which is comparable to conservative management of acute cholecystitis with antibiotics alone [3].
Endoscopic gallbladder decompression is an emerging therapeutic intervention that offers definitive non-operative management of acute cholecystitis. Data suggest that endoscopic gallbladder decompression is associated with fewer surgical interventions, adverse events (AEs), and unplanned hospital admissions when compared with PT-GBD [4]. The two techniques used for endoscopic gallbladder decompression are endoscopic transpapillary gallbladder drainage (ET-GBD) and endoscopic ultrasound-guided gallbladder drainage (EUS-GBD). ET-GBD is performed via endoscopic retrograde cholangiopancreatography (ERCP) with transpapillary placement of a stent into the gallbladder via the cystic duct (i.e., transcystic stenting). Modern EUS-GBD technique most commonly involves placement of a cautery-enhanced lumen-apposing metal stent (LAMS) into the gallbladder via a transgastric or transduodenal approach [5].
Prior studies comparing ET-GBD and EUS-GBD have shown EUS-GBD to have higher rates of technical success and lower rates of recurrent AC compared with ET-GBD [6]. However, these studies assessed ET-GBD mostly via single transcystic stent placement (SSET-GBD). Patients who undergo ET-GBD with dual transcystic stents (DSET-GBD) are less likely to have recurrent AC compared with SSET-GBD. This is likely because of a “wicking” effect, whereby two stents facilitate the flow of bile between the stents as opposed to through the stent lumens, which can easily become occluded over time. Thus, when a single transcystic stent is placed and becomes occluded, patients are at a likely increased risk of recurrent cholecystitis [7].
Prior studies have not compared performance characteristics of DSET-GBD with EUS-GBD and, therefore, it remains unclear which is the optimal method of endoscopic gallbladder drainage for poor surgical candidates. The aim of this study was to compare outcomes in patients with cholecystitis who had undergone EUS-GBD or DSET-GBD.
Patients and methods
Study design
The study was approved by the Institutional Review Boards of the University of Massachusetts Chan Medical School and Mayo Clinic, Rochester. In this multicenter, retrospective analysis, all consecutive patients who underwent endoscopic management of cholecystitis between January 2019 to January 2023 were evaluated. Demographic, medical, and procedural data were extracted from the electronic medical record (EMR). Inclusion criteria included patients with acute cholecystitis that were treated with ET-GBD or EUS-GBD with a minimum of 6-month follow-up. The EMR was reviewed to evaluate the severity of cholecystitis (as defined by Tokyo criteria), patient demographics, presence or absence of concomitant malignancy, and clinical outcomes for all included patients [8]. AEs were graded and reported based on the American Society of Gastrointestinal Endoscopy lexicon [9].
Endoscopic gallbladder drainage procedure
At our institutions, ET-GBD is attempted in patients who are non-surgical candidates at the time of their admission but may be surgical candidates in the future. Alternatively, EUS-GBD is performed in patients with AC who will never be surgical candidates even once their acute illness resolves. Conversion from one endoscopic modality to the other was attempted in cases where one previously failed due to technical reasons. This includes issues such as the presence of large-volume ascites, malignant obstruction, major papilla deformity, and a contracted gallbladder which could negatively impact an ET-GBD or EUS-GBD procedure. A flow chart diagram describing our approach to selecting ET-GBD or EUS-GBD techniques is shown in [Fig. 1]. This approach is similar to that of previously published expert opinions regarding the non-operative management of AC [10].
DSET-GBD procedure
DSET-GBD is a procedure conducted during ERCP. Typically, ERCP is performed using a 0.035-inch hydrophilic wire (Navipro, Boston Scientific, Marlborough Massachusetts, United States). The cystic duct is identified through cholangiogram or cholangioscopy, and a wire is passed into the cystic duct using a sphincterotome, balloon catheter, or via a cholangioscope. The cystic duct is dilated using a 4-mm biliary dilating balloon (Hurricane, Boston Scientific, Marlborough, Massachusetts, United States). A cytology brush (Rx Cytology Brush, Boston Scientific, Marlborough Massachusetts, United States) is then advanced over the wire, across the cystic duct, and into the gallbladder. The brush is then removed, leaving both the cytology sheath and the original guidewire in place. A second wire, usually a long 0.025-inch guidewire (Visiglide, Olympus America Inc., Lehigh Valley, Pennsylvania, United States), is passed into the gallbladder through the now-empty brush channel. The cytology brush sheath is then removed, leaving two wires in the gallbladder. A 7F double pigtail plastic stent is then deployed with the proximal pigtail in the gallbladder and the distal pigtail in the duodenum. Stent lengths in this study were 20 cm (Contour, Boston Scientific, Marlborough, Massachusetts, United States), 15 cm, and 12 cm. The cystic duct is dilated again with a 4-mm balloon over the second wire, and a second 7F stent is advanced into the gallbladder and deployed ([Video 1]). If only one stent was placed during the index procedure, the patient returned within 3 to 6 months for a second stent placement. If two stents were placed during the index procedure, the patient was considered to have received destination therapy, and the stents were left in place indefinitely.
Endoscopic transpapillary gallbladder drainage video describing tools and techniques for successful dual transcystic stent placement.Video 1EUS-GBD procedure
EUS-GBD is performed using a cautery-enhanced LAMS (AXIOS, Boston Scientific, Marlborough, Massachusetts, United States) and can be conducted via a transgastric (cholecystogastrostomy) or transduodenal (cholecystoduodenostomy) approach. The approach is left to the discretion of the endoscopist and is usually determined by which location allows for an adequate window to access the gallbladder. The procedure involves placing various sizes of LAMS within the gallbladder. A double pigtail coaxial stent is then placed within the LAMS itself. Most often the stents are left in place indefinitely. Follow-up procedures with lithotripsy and stone removal are usually not attempted.
Outcomes
The primary outcome of this study was the rate of recurrent cholecystitis between DS ET-GBD and EUS-GBD within 6 months after the index procedure. The secondary outcome was unplanned reintervention. Tertiary outcomes were rates of technical success, immediate clinical success, AEs (which were graded as mild, moderate, or severe), and all-cause mortality within 30 days of the procedure. Technical success was defined as successful placement of at least one transcystic stent in the ET-GBD group or LAMS into the gallbladder in the EUS-GBD group. Immediate clinical success was defined as successful discharge from the hospital after resolution of symptoms consistent with AC. DSET-GBD clinical success was only measured for patients who received two transcystic stents during the index procedure, whereas the rate of recurrent AC was measured for all patients who eventually had two transcystic stents placed. Patients who expired during the follow-up period for issues unrelated to cholecystitis were not evaluated for the primary outcome.
Statistical analyses
Demographic and clinical variables are reported as percentages or median with interquartile range (IQR) and were compared between groups using chi-squared and Mann-Whitney U tests, as appropriate. The association between procedure type and outcome was assessed in two ways. First, associations were assessed in the baseline cohort using univariable logistic regression and multivariable logistic regression adjusting for age. Next, we evaluated for association between procedure type and primary outcome in a propensity-matched cohort. Propensity score matching (PSM) was performed using several methods: nearest-neighbor, optimal, and full matching. The balance between groups was evaluated using standardized mean differences (SMDs). Covariate balance before and after matching was assessed using SMDs and visualized with Love plots. Among the different matching techniques, full matching provided the best covariate balance, which is a method that uses all control and treated units but applies weights to balance the covariates across the groups. After matching, two logistic regression models were run adjusting only for covariates with SMD > 0.25 to address residual imbalance. Strength of associations are reported as odds ratios (ORs) with 95% confidence intervals (CIs). All analyses were conducted using R. P < 0.05 was indicative of a significant difference.
Results
Patient overview
In total, 116 patients underwent 129 procedures (56 EUS-GBD and 73 ET-GBD) at our institutions during the study period. Technical success with placement of one or more stents was achieved in 49 of 56 procedures (87.5%) during which EUS-GBD was attempted and in 63 of 73 procedures (86.3%) during which ET-GBD was attempted (P = 1.000).
Patients who underwent successful EUS-GBD (n = 49) were significantly older than patients who underwent successful ET-GBD (n = 63) (median 79 years old vs. 70 years old, P < 0.001). Comorbidities including chronic obstructive pulmonary disease (P < 0.001), congestive heart failure (P = 0.037), and pancreaticobiliary malignancy (P = 0.010) were more common in the EUS-GBD group whereas cirrhosis was more common in the ET-GBD group (P = 0.018). There was a trend between ET-GBD and prior failed attempt at CCY (12.7% vs. 1.9% P = 0.076), but no difference in prior percutaneous gallbladder drainage (17.9% vs. 9.1%, P = 0.348). Demographics for patients with successful EUS-GBD or ET-GBD procedures are reported in [Table 1].
Procedure details
Reasons for technical failure in the EUS-GBD group (n = 7) included contracted gallbladders (n = 5) and presence of ascites (n = 2). Reasons for technical failure in the ET-GBD group (n = 10) included impacted cholelithiasis (n = 4), malignant obstruction (n = 2), duodenal stenosis (n = 1), and severe angulation/tortuous cystic duct (n = 3).
Of the 63 patients who successfully underwent ET-GBD, 36 patients (57.1%) had two stents placed during the index procedure and 27 patients (42.9%) had one stent placed during the index procedure. Cholangioscopy was used in 29.4% of the ET-GBD procedures. Of the 27 patients with one stent placed during the index procedure, 15 patients (55.5%) had a second transcystic stent placed during a follow-up procedure. On average, a second transcystic stent was placed within 6 months of the index procedure.
Ultimately, 51 of 63 ET-GBD patients (80.9%) successfully underwent DSET-GBD. Of the 12 ET-GBD patients who were only able to have one stent placed, seven (58.3%) went on to CCY and five (41.6%) required routine stent exchange because two transcystic stents were never able to be placed ([Fig. 2]).
For patients undergoing DSET-GBD, 7F x 20 cm double pigtail stents were placed 74.5% of the time ([Table 2]). In the EUS-GBD group, 38 patients (77.6%) underwent cholecystoduodenostomy, and 11 patients (22.4%) underwent cholecystogastrostomy. A 10 mm x 10 mm LAMS was placed in 37 patients (75.5%) and 35 (71.4%) had coaxial double pigtail placement at the time of the index procedure. Most coaxial pigtails were 7F x 4 cm ([Table 2]).
Outcomes
Immediate clinical success with resolution of AC was achieved in 98.1% of patients who successfully underwent EUS-GBD and 100% of the patients who successfully underwent DSET-GBD during the index procedure. Thirty-day mortality was lower in patients undergoing ET-GBD compared with EUS-GBD (2.0% vs. 12.2%), but this was not significant on age-adjusted analyses (OR 0.17, 95% CI 0.02–1.55, P = 0.117) ([Table 3]). Causes of death in the EUS-GBD group included septic shock (n = 1), out-of-hospital cardiac arrest (n = 2), death from underlying medical comorbidities (n = 2), and unknown causes (n = 1). In the ET-GBD group, one patient died from cardiac arrest. None of the deaths in this study were thought to be procedure-related. Only one patient in the EUS-GBD group experienced an AE related to the procedure including a bile leak requiring intensive care admission.
Primary and secondary outcome
The rate of recurrent cholecystitis did not differ in patients who underwent EUS-GBD and DEST-GBD (5.3% vs 8.2%, respectively; P = 0.692) (Table 3). A similar proportion of patients who underwent EUS-GBD and ET-GBD required an unplanned repeat procedure (8.2% vs. 10.0%, P = 1.000). In the propensity-matched cohort, multivariable logistic regression revealed no association between procedure type and unscheduled repeat procedure (OR 1.75, 95% CI 0.32–10.9, P = 0.514) or recurrent cholecystitis at 6 months (OR 1.26, 95% CI 0.16–10.8, P = 0.20) on adjusted analyses ([Table 4]).
Discussion
Endoscopic gallbladder drainage has emerged as an alternative method to treat AC for patients who are not surgical candidates. Despite this, it remains unclear which endoscopic technique is best for managing AC. Published expert opinions have recommended EUS-GBD ahead of ET-GBD for management of AC [10]. These opinions were based on prior research that demonstrated that EUS-GBD has lower rates of recurrent AC than ET-GBD. However, most comparative studies evaluated ET-GBD patients who only had a single transcystic stent placed [11]. Importantly, a study by Storm et al. demonstrated that patients undergoing DSET-GBD had much lower rates of recurrent AC [7]. Our study is the first to compare outcomes for patients undergoing EUS-GBD and DSET-GBD. In our study, our results show that EUS-GBD and DSET-GBD have similarly high rates of technical success and clinical success while maintaining a low incidence of AEs and recurrent cholecystitis.
Outcomes from this study are quite different than what has been reported previously when EUS-GBD and ET-GBD have been compared. A study by Siddiqui et al. noted that patients undergoing EUS-GBD had significantly fewer instances of recurrent AC compared with ET-GBD, which may be explained by the patient population, which primarily included individuals undergoing single transcystic stent placement [4]. Single transcystic stents placed into the gallbladder are likely to occlude over the long term, which can subsequently result in AC. When two transcystic stents are placed, bile can drain between the stents even if they become occluded, thus recurrent AC should be less common. This principle is similar to EUS-guided drainage of pancreatic pseudocysts, whereby placement of two stents facilitates drainage better than a single stent [12].
In the DSET-GBD group in this study, there were four events of recurrent AC. Two of these events occurred in patients with prior biliary manipulation (e.g. PT-GBD). Our theory is that prior attempts at gallbladder manipulation increase risk of cystic duct scarring, which could limit the benefit of DSET-GBD. Otherwise, DSET-GBD offers advantages such as preservation of native anatomy and simultaneous clearance of concomitant choledocholithiasis.
Importantly, DSET-GBD is technically challenging. In our cohort, only 80.9% of patients undergoing ET-GBD could have two stents placed. Although DSET-GBD is difficult to perform, it is a viable alternative with favorable outcomes and performs well in situations in which EUS-GBD is contraindicated, such as in cirrhotic patients with large-volume ascites.
Our study has several limitations. Inherent shortcomings arise from its retrospective design, which introduces selection bias, because the choice of endoscopic gallbladder drainage over alternative modalities was determined on a case-by-case basis by a multidisciplinary team of surgeons, interventional radiologists, and gastroenterologists. It is worth noting that patients who underwent EUS-GBD were significantly older compared with patients who underwent ET-GBD, likely because this approach is favored in non-surgical patients. The ET-GBD group included patients considered to never be surgical candidates as well as those who were not surgical candidates at the time of their presentation but could potentially be surgical candidates in the future. In addition, it is important to consider that our procedures were conducted at high-volume centers and the technical success rate and safety profile of endoscopic gallbladder drainage observed in our study may not be generalizable to all healthcare centers.
Conclusions
Rates of acute cholecystitis continue to rise along with an aging population. Endoscopic modalities for gallbladder drainage have been proven as safe, feasible, and effective. We present data demonstrating that DS ET-GBD has similarly low rates of recurrent acute cholecystitis compared with EUS-GBD. DS ET-GBD adds another technique to the endoscopic arsenal for management of AC in patients who are unable to undergo laparoscopic CCY while having the added benefit of maintaining future surgical candidacy. A randomized controlled trial should be considered to further demonstrate the comparative efficacy of EUS-GBD and DSET-GBD.
Conflict of Interest
Dr. Nasser-Ghodsi is a consultant for Boston Scientific Dr. Andrew Storm is a consultant for Apollo Endosurgery, ERBE, GI dynamics, and Olympus. Dr. Marya is a consultant for Boston Scientific None of the remaining authors have any conflicts of interest to disclose.
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Krishnamoorthi R,
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EUS-guided versus endoscopic transpapillary gallbladder drainage in high-risk surgical
patients with acute cholecystitis: a systematic review and meta-analysis. Surg Endosc
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Teoh AYB,
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Correspondence
Publication History
Received: 24 June 2024
Accepted after revision: 16 December 2024
Accepted Manuscript online:
02 January 2025
Article published online:
29 January 2025
© 2025. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).
Georg Thieme Verlag KG
Oswald-Hesse-Straße 50, 70469 Stuttgart, Germany
Dhruval Amin, Katherine M. Cooper, Prashanth Rau, Lea Sayegh, Nouran Mostafa, Ikechukwu Achebe, Zachary DeVore, Daniella Gonzalez, Stephanie Stephanie, Jaroslav Zivny, Savant Mehta, Christopher Marshall, Navine Nasser-Ghodsi, Andrew C Storm, Neil B. Marya. EUS-guided gallbladder drainage vs dual stent transpapillary gallbladder drainage for management of acute cholecystitis. Endosc Int Open 2025; 13: a25097076.
DOI: 10.1055/a-2509-7076
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References
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Baron TH,
Grimm IS,
Swanstrom LL.
Interventional approaches to gallbladder disease. N Engl J Med 2015; 373: 357-365
MissingFormLabel
- 2
Lu P,
Chan C-L,
Yang N-P.
et al.
Outcome comparison between percutaneous cholecystostomy and cholecystectomy: A 10-year
population-based analysis. BMC Surg 2017; 17: 1-12
MissingFormLabel
- 3
Wiggins T,
Markar SR,
Mackenzie H.
et al.
Evolution in the management of acute cholecystitis in the elderly: population-based
cohort study. Surg Endosc 2018; 32: 4078-4086
MissingFormLabel
- 4
Siddiqui A,
Kunda R,
Tyberg A.
et al.
Three-way comparative study of endoscopic ultrasound-guided transmural gallbladder
drainage using lumen-apposing metal stents versus endoscopic transpapillary drainage
versus percutaneous cholecystostomy for gallbladder drainage in high-risk surgical
patients with acute cholecystitis: Clinical outcomes and success in an international,
multicenter study. Surg Endosc 2019; 33: 1260-1270
MissingFormLabel
- 5
Saumoy M,
Yang J,
Bhatt A.
et al.
Endoscopic therapies for gallbladder drainage. Gastrointest Endosc 2021; 94: 671-684
MissingFormLabel
- 6
Higa JT,
Sahar N,
Kozarek RA.
et al.
EUS-guided gallbladder drainage with a lumen-apposing metal stent versus endoscopic
transpapillary gallbladder drainage for the treatment of acute cholecystitis (with
videos). Gastrointest Endosc 2019; 90: 483-492
MissingFormLabel
- 7
Storm AC,
Vargas EJ,
Chin JY.
et al.
Transpapillary gallbladder stent placement for long-term therapy of acute cholecystitis.
Gastrointest Endosc 2021; 94: 742-748 e741
MissingFormLabel
- 8
Wakabayashi G,
Iwashita Y,
Hibi T.
et al.
Tokyo Guidelines 2018: Surgical management of acute cholecystitis: safe steps in laparoscopic
cholecystectomy for acute cholecystitis (with videos). J Hepatobiliary Pancreat Sci
2018; 25: 73-86
MissingFormLabel
- 9
Cotton PB,
Eisen GM,
Aabakken L.
et al.
A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest
Endosc 2010; 71: 446-454
MissingFormLabel
- 10
Irani SS,
Sharzehi K,
Siddiqui UD.
AGA Clinical Practice Update on Role of EUS-Guided Gallbladder Drainage in Acute Cholecystitis:
Commentary. Clin Gastroenterol Hepatol 2023; 21: 1141-1147
MissingFormLabel
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Krishnamoorthi R,
Jayaraj M,
Thoguluva Chandrasekar V.
et al.
EUS-guided versus endoscopic transpapillary gallbladder drainage in high-risk surgical
patients with acute cholecystitis: a systematic review and meta-analysis. Surg Endosc
2020; 34: 1904-1913
MissingFormLabel
- 12
Teoh AYB,
Ho LKY,
Dhir VK.
et al.
A multi-institutional survey on the practice of endoscopic ultrasound (EUS) guided
pseudocyst drainage in the Asian EUS group. Endosc Int Open 2015; 3: E130-E133
MissingFormLabel