Subscribe to RSS
DOI: 10.1055/a-0759-1353
Lumen-apposing stents versus plastic stents in the management of pancreatic pseudocysts: a large, comparative, international, multicenter study
Corresponding author
Publication History
submitted 16 February 2018
accepted after revision 05 September 2018
Publication Date:
07 December 2018 (online)
Abstract
Background Larger caliber lumen-apposing stents (LAMSs) have been increasingly used in the management of pancreatic fluid collections, specifically when solid debris is present; however, their advantages over smaller caliber plastic stents in the management of pancreatic pseudocysts are unclear. The aim of this study was to investigate the safety and efficacy of LAMS specifically in the management of pancreatic pseudocysts compared with double-pigtail plastic stents (DPPSs).
Methods We performed a multicenter, international, retrospective study between January 2012 and August 2016. A total of 205 patients with a diagnosis of pancreatic pseudocysts were included, 80 patients received LAMSs and 125 received DPPSs. Measured outcomes included clinical success, technical success, adverse events, stent dysfunction, pancreatic pseudocyst recurrence, and need for surgery.
Results Technical success was similar between the LAMS and the DPPS groups (97.5 % vs. 99.2 %; P = 0.32). Clinical success was higher for LAMSs than for DPPSs (96.3 % vs. 87.2 %; P = 0.03). While the need for surgery was similar between the two groups (1.3 % vs. 4.9 %, respectively; P = 0.17), the use of percutaneous drainage was significantly lower in the LAMS group (1.3 % vs. 8.8 %; P = 0.03). At 6-month follow-up, the recurrence rate was similar between the groups (6.7 % vs 18.8 %, respectively; P = 0.12). The rate of adverse events was significantly higher in the DPPS group (7.5 % vs. 17.6 %; P = 0.04). There was no difference in post-procedure mean length of hospital stay (6.3 days [standard deviation 27.9] vs. 3.7 days [5.7]; P = 0.31).
Conclusion When compared to DPPSs, LAMSs are a safe, feasible, and effective modality for the treatment of pancreatic pseudocysts and are associated with a higher rate of clinical success, shorter procedure time, less need for percutaneous interventions, and a lower overall rate of adverse events.
#
Introduction
Pancreatic pseudocysts occur in 5 % – 15 % of patients following episodes of acute pancreatitis and up to 40 % of patients with chronic pancreatitis [1] [2] [3] [4]. Pancreatic pseudocyst formation occurs when leakage of pancreatic fluid becomes surrounded by a rim of inflammatory or fibrous tissue [5]. The majority of patients with pancreatic pseudocysts are asymptomatic and the collection will resolve spontaneously; however, drainage is indicated when symptoms such as abdominal pain and gastric outlet obstruction arise or in the presence of infection [6].
Traditionally, management strategies for complicated pancreatic pseudocysts have included surgical intervention, percutaneous drainage, and endoscopic drainage [7] [8] [9]. Each of these techniques has advantages and disadvantages. For example, surgical drainage is considered invasive and is associated with prolonged hospital stay and increased cost, while percutaneous drainage can lead to pancreaticocutaneous fistula formation [8] [9] [10] [11] [12]. Endoscopic ultrasound (EUS)-guided transluminal drainage has become the preferred first-line modality for drainage of pancreatic pseudocysts at many tertiary care centers [4] [10] [11] [12] [13] [14].
In 1991, the first transmural pseudocyst drainage was performed using plastic stents [15] [16]. However, because of their small caliber, plastic stents are prone to stent occlusion and their placement is technically challenging, involving placement of multiple stents and repetitive wire access [17]. Recently, lumen-apposing metal stents (LAMSs) were developed for the management of pancreatic fluid collections (PFCs) [7]. There are currently three different LAMSs: AXIOS (Boston Scientific, Marlborough, Massachusetts, USA), NAGI, and SPAXUS (both Taewoong Medical, Seoul, South Korea), but only the AXIOS is currently available in the USA. This novel stent is characterized by antimigratory flared bi-flanges, larger luminal diameters (10 mm, 15 mm, and 20 mm), and a compact one-step cautery-assisted delivery system.
Data on LAMSs in the management of walled-off necrosis (WON) have shown excellent results; however, despite recent publications directly comparing LAMSs to double-pigtail plastic stents (DPPSs) in the management of pancreatic pseudocysts, the overall literature in this area remains low in comparison to that on WON [9]. In addition, published studies have frequently included both WON and pancreatic pseudocysts, which have different outcomes following endoscopic intervention.
The objective of this international, multicenter, retrospective study is to compare clinical outcomes of EUS-guided transmural drainage of pancreatic pseudocysts using LAMSs (AXIOS) vs. DPPSs.
#
Methods
This international, multicenter, retrospective study involved 14 tertiary hospitals: 12 from the USA and 2 from Europe ([Table e1]). Consecutive patients who underwent EUS-guided pancreatic pseudocyst drainage with either a LAMS or DPPS between January 2012 and August 2016 were included. Patients with WON and those with < 30 days of follow-up were excluded [18].
Pancreatic pseudocysts were defined according to the revised Atlanta classification as an organized collection with homogenous fluid density on imaging (computed tomography [CT], magnetic resonance imaging [MRI], and/or EUS) without a non-liquid component and with a well-defined wall arising about 4 weeks post-acute interstitial pancreatitis [18]. WON was defined as an organized collection containing both liquid and solid components that developed 4 weeks post-acute necrotizing pancreatitis.
Patients were identified using center-specific endoscopic or billing databases. Electronic records were reviewed to capture the following variables: demographics; pancreatic pseudocyst location and size; etiology of pancreatitis; paracolic fluid extension; presence of main pancreatic duct (MPD) disruption or leak based on endoscopic retrograde cholangiopancreatography (ERCP) findings; indication for drainage; stent type and size; number of stents; drainage approach (transgastric, transduodenal, transesophageal); technical success; procedure time; percutaneous drain insertion and size; clinical success; success of stent removal; ERCP performed within 30 days pre- or post-index procedure; insertion of transpapillary pancreatic stent; pancreatic pseudocyst recurrence; need for surgery; adverse events, graded according to the American Society for Gastrointestinal Endoscopy (ASGE) lexicon [19]; length of hospital stay; and duration of follow-up. None of the patients had been reported in previous studies.
Procedure technique
Drainage of pancreatic pseudocysts with a LAMS
Pre-procedure informed consent was obtained from all patients. Prophylactic antibiotics were given at the discretion of the endoscopist and as per institutional protocol. All procedures were performed by interventional endoscopists using linear array echoendoscopes. The procedures were performed with the patients under monitored anesthesia, general anesthesia, or moderate/deep sedation.
Prior to pancreatic pseudocyst puncture, a linear echoendoscope was used to evaluate its size and location, the presence of solid debris, and the surrounding organs. Color Doppler ultrasound was then used to exclude intervening vascular structures. After careful visualization of the PFC, the distance between the EUS probe and the pancreatic pseudocyst was carefully measured to assure the targeted access site was within a distance of 1 cm ([Fig. 1]). The LAMS was subsequently inserted into the pancreatic pseudocyst cavity with cautery assistance, followed by deployment of the distal flange and then the proximal flange under direct EUS or endoscopic guidance.
If a non-cautery LAMS was used, the pancreatic pseudocyst was first punctured with a 19G needle, followed by coiling of 0.025 – or 0.035-inch guidewire within the pancreatic pseudocyst under fluoroscopic guidance, tract dilation, and LAMS insertion. Dilation of the stent with a radial expansion balloon was performed at the discretion of the endoscopist.
#
Drainage of pancreatic pseudocysts with a DPPS
The same pre-procedural protocol was followed: the pancreatic pseudocyst was assessed with a linear echoendoscope and the cavity was punctured with a 19G fine needle aspiration (FNA) needle from the stomach or the duodenum. A 0.025 – or 0.035-inch guidewire was advanced and coiled within the cyst cavity under fluoroscopic guidance. Tract dilation was then performed with either a cystotome or radial expansion balloon to facilitate stent placement. The DPPS was then inserted over the guidewire under fluoroscopic guidance. The number and the size of the stents placed were at the discretion of the endoscopist.
#
#
End points
The primary end point was clinical success, defined as a reduction of the pancreatic pseudocyst to ≤ 3 cm on CT/MRI [20] [21] [22], with corresponding clinical symptom resolution within 6 months of stent insertion, and without the need for percutaneous drainage or surgery.
Secondary end points included: the rate of technical success; adverse events, with severity graded as per the ASGE lexicon [19]; stent migration; pancreatic pseudocyst recurrence (defined as recurrent symptoms and increase in pancreatic pseudocyst diameter > 3 cm); and the need for surgery. Technical success was defined as successful placement of a LAMS or DPPS to the intended target.
#
Statistical analysis
Continuous variables were reported as mean and standard deviation (SD), or median and range, where appropriate. Categorical variables were reported as proportions and 95 % confidence intervals (CIs), with inferential analysis performed using chi-squared testing. Student’s t test and Wilcoxon’s rank sum test were used for continuous variables. A level of significance of P < 0.05 was adopted for all inferential testing.
Multivariable analysis was performed using step-by-step logistic regression. All variables on univariable analysis with a P value < 0.1 were considered for multivariable analysis.
#
#
Results
Patient demographics
A total of 205 patients (mean age 54.5 [SD 14.1]; 37 % women) were identified, comprising 80 patients treated with a LAMS (cautery-enhanced LAMS, n = 48; non-cautery-enhanced LAMS, n = 32) and 125 patients treated with a DPPS ([Table 2]).
SD, standard deviation.
The etiologies of acute pancreatitis were: alcohol (32.3 %), gallstones (20 %), idiopathic (19.5 %), other (18.5 %), trauma (5.8 %), post-ERCP (3.4 %), and autoimmune (0.5 %). The primary indications for drainage were: abdominal pain (59.4 %), gastric outlet obstruction (15.8 %), early satiety (10.9 %), infection (8.8 %), biliary obstruction (2.4 %), other (1.5 %), and rapid increase in pancreatic pseudocyst size (0.98 %). Pancreatic pseudocysts were located in the body (44.4 %), tail (27.8 %), head (22.9 %), extrapancreatic (2 %), multiple locations (1 %), and other (1.9 %). The mean diameter of the pancreatic pseudocysts was 106.4 mm (SD 48.8 mm) for LAMS and 101.8 mm (SD 53.6 mm) for DPPS (P = 0.54). Paracolic gutter extension was noted in 7.7 % of LAMS patients and 12.3 % of DPPS patients (P = 0.29).
A total of 74 patients in the LAMS group and 105 patients in the DPPS group underwent imaging evaluations. Pancreatic duct leak occurred in 18 patients in the LAMS group and 32 in the DPPS group. Disconnected pancreatic duct was observed in 22.2 % (4 /18) in the LAMS group and 18.8 % (6 /32) in the DPPS group (P = 0.77).
#
Procedure characteristics
Transgastric stenting was the most common approach in both groups (85 % LAMS vs. 86.4 % DPPS; P = 0.46) ([Table 3]). Procedure time was significantly shorter in the LAMS group (43.2 minutes [SD 24.4] vs. 65.5 minutes [SD 27.0]; P < 0.001). The average number of stents used in the LAMS group was significantly lower than that in the DPPS group (1.1 [SD 0.28] vs. 1.9 [SD 0.57]; P < 0.001). The total number of endoscopic procedures prior to stent removal was similar between the two groups (1 [interquartile range (IQR) 1 – 2] vs. 1 [IQR 1 – 1]; P = 0.24). ERCP was performed in 28.8 % of LAMS patients and 32.0 % of DPPS patients (P = 0.62), with pancreatic duct stent insertion performed in 18 /18 (100 %) in the LAMS group and 28 /32 (87.5 %) in the DPPS group (P = 0.28).
IQR, interquartile range; ERCP, endoscopic retrograde cholangiopancreatography; SD, standard deviation.
#
Clinical end points and adverse events
Technical success was achieved in 97.5 % (78 /80) of patients in the LAMS group compared to 99.2 % (124 /125) in the DPPS group (P = 0.32) ([Table 4]). Post-procedure mean length of hospital stay was not significantly different between the LAMS and DPSS groups (6.3 days [SD 27.9] vs. 3.7 days [SD 5.7], respectively; P = 0.31). Clinical success was significantly higher in the LAMS group (96.3 % vs. 87.2 %; P = 0.03). The need for percutaneous drainage was significantly lower in the LAMS group (1.3 % vs. 8.8 %; P = 0.03); however, the need for surgery was similar between the two groups (1.3 % vs. 4.9 %, respectively; P = 0.17).
|
Lumen-apposing stent (n = 80) |
Plastic stent (n = 125) |
P value |
95 % confidence limits for difference |
|
|
Technical success, n (%) |
78 (97.5 %) |
124 (99.2 %) |
0.32 |
− 0.02, 0.05 |
|
Clinical success, n (%) |
77 (96.3 %) |
109 (87.2 %) |
0.03 |
− 0.01, 0.18 |
|
Length of hospital stay, mean (SD), days |
6.3 ± 27.9 |
3.7 ± 5.7 |
0.31 |
− 2.3, 8.1 |
|
Percutaneous drain, n (%) |
1 (1.3 %) |
11 (8.8 %) |
0.03 |
0.0, 0.1 |
|
Surgical intervention, n (%) |
1 (1.3 %) |
6 (4.9 %) |
0.17 |
− 0.0, 0.1 |
|
Recurrence, n (%)[1] |
5 (6.7 %) |
23 (18.8 %) |
0.12 |
− 0.0, 0.3 |
SD, standard deviation.
* Rates were calculated after excluding patients with less than 6 months of follow-up, 39 in the double-pigtail plastic stent group and 43 in the lumen-apposing metal stent group.
A total of 28 adverse events were observed with an overall adverse event rate of 13.7 % ([Table 5]). The rate of adverse events was significantly higher in the DPPS group (7.5 % [n = 6] vs. 17.6 % [n = 22]; P = 0.04). Adverse events included infection (n = 12), bleeding (n = 7), stent misdeployment (n = 3), perforation (n = 2), and others (n = 4). In terms of severity, 3.9 % were rated as mild, 6.8 % as moderate, and 2.9 % as severe. Of adverse events among LAMS patients, 16.7 % (n = 1) were classified as severe; among DPPS patients, 27 % (n = 6) were severe. In the LAMS group, one severe adverse event occurred related to infection and was managed with re-insertion of a plastic stent. In the DPPS group, a total of five severe adverse events occurred: three cases of bleeding and two of perforation, all of which were managed with interventional radiology. There was no procedure-related mortality.
The migration rate was 8.8 % in the LAMS group and 4.8 % in the DPPS group (P = 0.26). After excluding 39 patients in the DDPS group and 43 patients in the LAMS group with < 6 months of follow-up, there was no statistical difference in recurrence between the LAMS and DPPS groups (18.8 % vs. 6.7 %; P = 0.12). The median length of follow-up was 152 days (IQR 66.8 – 395.5) for LAMS patients and 429 days (IQR 119 – 980) for DPPS patients (P < 0.001).
#
Predictors of clinical success
Univariable analysis of the aforementioned variables identified LAMS placement as a positive predictor of clinical success (P = 0.04). Furthermore, paracolic gutter extension (P < 0.001) was identified as a negative predictor of clinical success.
The multivariable analysis showed decreased procedure time and lower use of pancreatic duct stent placement were correlated with clinical success, while younger age and increased number of endoscopic interventions prior to stent removal were correlated with adverse events ([Table 6]).
#
#
Discussion
The development of pancreatic pseudocysts remains a common complication of pancreatitis and a significant socioeconomic burden, given their predisposition to infection and symptom causation [4]. The overall treatment success using DPPSs in transmural drainage of pancreatic pseudocysts is reported to be between 85 % and 95 %, a finding attributed to the thin, relatively debris-free pancreatic pseudocyst content [21] [23] [24] [25] [26]. However, there are several disadvantages to the use of DPPSs, including the small lumen diameter, requiring placement of multiple stents to obtain adequate drainage, stent occlusion, and stent-related adverse events in up to 18 % of patients [27]. Because of these limitations of DPPS, the larger caliber biliary fully covered self-expanding metal stents (FCSEMSs) have been used in the management of both pancreatic pseudocysts and WON.
In 2012, Penn et al. successfully demonstrated the use of biliary FCSEMSs in the drainage of pancreatic pseudocysts [28]. Although this approach is associated with high rates of clinical success, the straight FCSEMS is not optimally designed for cyst fluid drainage because of the lack of lumen apposition and its long length, which leads to migration rates upwards of 15 %. LAMSs, with their unique dumb-bell shaped flanges and a shorter saddle, were developed to overcome the shortcomings of biliary SEMSs [21] [28] [29] [30] [31] [32]. Early outcome data on the use of LAMSs for PFCs have been encouraging, with an overall technical success rate exceeding 95 %, clinical success rates of 85 % – 91 %, 5 % migration rate, and 10 % – 15 % adverse event rate [6] [7] [13] [24] [33] [34] [35].
Large direct comparative studies of LAMSs with DPPSs in pancreatic pseudocyst management are lacking and there has not been strong evidence favoring one type of stent over the other in terms of clinical or technical success. [Table 7] summarizes the studies that have compared the outcomes of LAMSs vs. DPPSs in the management of PFCs. All these studies [20] [29] [31] [36] [37] [38] included small numbers of LAMS patients treated with the AXIOS stent for pseudocysts (collectively a total of 60), as most had a mix of both WON and pancreatic pseudocyst collections (all but one study [20]), or a different type of LAMS (NAGI) that is not available in the USA had been used [29]. Ge et al. [20] specifically compared LAMSs vs. DPPSs in the drainage of only pancreatic pseudocysts and showed DPPSs are associated with increased risk of re-intervention and increased migration and cyst leakage. The paucity of literature on this topic may be a contributor to the conflicting conclusions with regard to stent type for pancreatic pseudocyst management.
|
Study |
Stent types |
n |
Type of pancreatic fluid collection |
Technical success |
Clinical success |
Adverse |
Recurrence |
||
|
Ang et al. |
LAMS (NAGI) |
12 |
WON 4 |
4 (100 %) |
11 (91.7 %) |
No difference (P = 0.07) |
None |
6.3 % |
No difference |
|
PP 8 |
8 (100 %) |
||||||||
|
DPPS |
37 |
WON 10 |
10 (100 %) |
24 (64.9 %) |
5 (13.5 %) |
7.9 % |
|||
|
PP 27 |
27 (100 %) |
||||||||
|
Bang et al. |
LAMS (AXIOS) |
20 |
WON 13 |
13 (100 %) |
12 (92.9 %) |
No difference (P = 0.99) |
4 (30.8 %) |
No difference |
|
|
PP 7 |
7 (100 %) |
7 (100 %) |
None |
1 (14.2 %) |
|||||
|
DPPS |
40 |
WON 26 |
26 (100 %) |
24 (92.3 %) |
6 (23.1 %) |
||||
|
PP 14 |
14 (100 %) |
13 (92.9 %) |
None |
4 (28.5 %) |
|||||
|
Itoi et al. |
LAMS (AXIOS) |
15 |
PP |
15 (100 %) |
15 (100 %) |
None |
1 (6.7 %) |
None |
|
|
Khashab et al. |
LAMS (AXIOS) |
80 |
PP |
78 (97.5 %) |
77 (96.3 %) |
Significantly improved clinical success (P = 0.03) |
6 (7.5 %) |
6.70 % |
No difference |
|
DPPS |
125 |
124 (99.2 %) |
109 (87.2 %) |
22 (17.6 %) |
18.80 % |
||||
|
Ge et al. |
LAMS |
12 |
PP |
29 (100 %) |
52 (100 %) |
No difference |
1 (8.3 %) |
15.40 % |
Significant difference[1] |
|
DPPS |
40 |
3 (7.5 %) |
|||||||
|
Lang et al. |
LAMS |
19 |
WON 9 |
18 (94 %) |
99 % |
No difference |
10 (53 %) |
1 (5.3 %) |
No difference |
|
PP 10 |
|||||||||
|
DPPS |
84 |
WON 14 |
81 (96 %) |
9 (12 %) |
3 (3.6 %) |
||||
|
PP 70 |
|||||||||
|
Brimhall et al. |
LAMS |
97 |
WON 81 |
90 (92.8 %) |
97.6 % |
No difference (P = 0.71) |
24 (24.7 %)[2] |
4.6 % |
No difference |
|
PP 16 |
|||||||||
|
DPPS |
152 |
WON 116 |
137 (90.1 %) |
96.7 % |
27 (17.8 %) |
6.2 % |
|||
WON, walled-off necrosis; PP, pancreatic pseudocyst.
1 Significantly increased risk of re-intervention with DPSS.
2 No difference between LAMS vs. DPPS; however, LAMS showed a higher risk of pseudoaneurysm.
The current report is the largest study to compare the outcomes of the use of LAMS and DPPS and included only patients with pancreatic pseudocysts. Our study demonstrated that LAMS placement for pancreatic pseudocyst management is associated with an overall higher clinical success (P = 0.03), shorter procedure time (P < 0.001), a lower rate of percutaneous drainage (P = 0.03), and a lower rate of adverse events (P = 0.04) when compared to DPPS placement. The most frequent adverse events encountered were infection and bleeding. These complications have been well reported in the literature, with rates ranging from 15 % to 26 % [9] [17] [19] [25] [31] [39] [40]. The overall rate of infection in our study was 5.9 % (12/205). Out of these 12 cases of infections, 11 were encountered in the DPPS group. This higher number of infectious complications is likely due to occlusion of the DPPS by food debris and bacterial film formation.
There has been a recent concern about increased risk of bleeding with the use of LAMSs for the drainage of PFCs [41]. One study comparing LAMSs and DPPSs in PFCs showed a significantly higher rate of bleeding in the LAMS group compared to the DPPS group (19 % vs. 1 %; P = 0.003) [37]. The proposed explanations were that the rapid collapse of the collection caused erosion or direct impingement of the LAMS into vessels following cyst cavity collapse, leading to pseudoaneurysm formation and hemorrhage; on the other hand, the softer plastic stents were thought to be less likely to cause bleeding following cyst collapse.
This finding was not however reflected in our study, nor in other large registry-based studies [42] [43] [44]. In our study, six out of the seven bleeding events occurred in the DPPS group: three were severe requiring interventional radiology input and the rest were managed endoscopically. This difference may be due to heterogeneity in the previous studies, because they included either exclusively WON or a mixture of WON and pancreatic pseudocysts [7] [9] [26] [37] [45]. In addition, variability in interpretations of adverse events, nomenclatures, and procedure complexities persists among endoscopists, despite using the ASGE lexicon. These factors may contribute to the differences in incidence and adverse event outcomes between studies [19] [46].
There are several limitations to our study. Firstly, it is a retrospective study, which carries inherent limitations, including a lack of standardized algorithm of stent management across the multiple centers and lack of long-term follow-up. In addition, only tertiary referral centers were involved, which would limit its generalizability to other centers with less experience and access to the LAMS used in our study. This study specifically applies to the use of AXIOS and cannot be generalized to other LAMS such as the NAGI and SPAXUS stents. In addition, the median follow-up time was significantly longer in the DPPS group (P < 0.001).
Furthermore, a uniform definition of clinical success is lacking and varies between different studies, which may be a factor accounting for the differences in clinical outcomes [20] [22] [27] [36] [41] [47] [48]. Finally, we did not evaluate the cost-effectiveness of using LAMSs in pancreatic pseudocyst drainage and we did not separate early and late adverse events. The strengths of this study include its multicenter design, large number of patients in comparison to prior studies on pancreatic pseudocyst drainage, and the exclusion of WON patients.
In conclusion, in this large, multicenter, international study, our data suggest that, in comparison to the use of DPPSs, the use of LAMSs in the endoscopic drainage of pancreatic pseudocysts is associated with higher clinical success, shorter procedure time, less need for percutaneous interventions, and a lower rate of adverse events.
Yang J, Chen YI, Friedland S et al. Lumen-apposing stents versus plastic stents in
the management of pancreatic pseudocysts: a large, comparative, international, multicenter
study Endoscopy, DOI 10.1055/a-0759-1353
In the above-mentioned article, the name of the author Srinivas Gaddam has been corrected.
This was corrected in the online version on February 14, 2019
#
#
Competing interests
S. Friedland is a consultant for Boston Scientific and C2 Therapeutics; T. Stevens is a speaker and consultant for Boston Scientific and a speaker for AbbVie pharmaceuticals; C. J. DiMaio is a consultant for Boston Scientific and Medtronic; L. H. Jamil is a consultant for Aries pharmaceutical; P. S. Yachimski is a consultant for Boston Scientific; J. Nieto is a consultant for Boston Scientific; V. Kumbhari is a consultant for ReShape Life Sciences, Apollo Endosurgery, Medtronic, and Boston Scientific, and has received consulting fees from Pentax Medical and C2 Therapeutics; V. Singh is a consultant for Abbvie, D-Pharm, and Santarus; E. J. Shin is a consultant for Boston Scientific and C2 Therapeutics; M. Khashab is a consultant for Boston Scientific and Olympus, and is also on the medical advisory board for Boston Scientific and Olympus. All other co-authors have no conflict of interest disclosures.
-
References
- 1 Poornachandra KS, Bhasin DK, Nagi B. et al. Clinical, biochemical, and radiologic parameters at admission predicting formation of a pseudocyst in acute pancreatitis. J Clin Gastroenterol 2011; 45: 159-163
- 2 Tyberg A, Karia K, Gabr M. et al. Management of pancreatic fluid collections: A comprehensive review of the literature. World J Gastroenterol 2016; 22: 2256-2270
- 3 Maringhini A, Uomo G, Patti R. et al. Pseudocysts in acute nonalcoholic pancreatitis: incidence and natural history. Dig Dis Sci 1999; 44: 1669-1673
- 4 Nealon WH, Bhutani M, Riall TS. et al. A unifying concept: pancreatic ductal anatomy both predicts and determines the major complications resulting from pancreatitis. J Am Coll Surg 2009; 208: 790-799 ; discussion 799–801
- 5 Singhal S, Rotman SR, Gaidhane M. et al. Pancreatic fluid collection drainage by endoscopic ultrasound: an update. Clin Endosc 2013; 46: 506-514
- 6 Kahaleh M, Shami VM, Conaway MR. et al. Endoscopic ultrasound drainage of pancreatic pseudocyst: a prospective comparison with conventional endoscopic drainage. Endoscopy 2006; 38: 355-259
- 7 Shah RJ, Shah JN, Waxman I. et al. Safety and efficacy of endoscopic ultrasound-guided drainage of pancreatic fluid collections with lumen-apposing covered self-expanding metal stents. Clin Gastroenterol Hepatol 2015; 13: 747-752
- 8 Baron TH, Harewood GC, Morgan DE. et al. Outcome differences after endoscopic drainage of pancreatic necrosis, acute pancreatic pseudocysts, and chronic pancreatic pseudocysts. Gastrointest Endosc 2002; 56: 7-17
- 9 Sharaiha RZ, Tyberg A, Khashab MA. et al. Endoscopic therapy with lumen-apposing metal stents is safe and effective for patients with pancreatic walled-off necrosis. Clin Gastroenterol Hepatol 2016; 14: 1797-1803
- 10 Varadarajulu S, Bang JY, Sutton BS. et al. Equal efficacy of endoscopic and surgical cystogastrostomy for pancreatic pseudocyst drainage in a randomized trial. Gastroenterology 2013; 145: 583-590.e1
- 11 Varadarajulu S, Lopes TL, Wilcox CM. et al. EUS versus surgical cyst-gastrostomy for management of pancreatic pseudocysts. Gastrointest Endosc 2008; 68: 649-655
- 12 Teoh AY, Dhir V, Jin ZD. et al. Systematic review comparing endoscopic, percutaneous and surgical pancreatic pseudocyst drainage. World J Gastrointest Endosc 2016; 8: 310-318
- 13 Giovannini M. Endoscopic ultrasound-guided pancreatic pseudocyst drainage. Gastrointest Endosc Clin N Am 2005; 15: 179-188, xi
- 14 Parks RW, Tzovaras G, Diamond T. et al. Management of pancreatic pseudocysts. Ann R Coll Surg Engl 2000; 82: 383-387
- 15 Pfaffenbach B, Langer M, Stabenow-Lohbauer U. et al. [Endosonography controlled transgastric drainage of pancreatic pseudocysts]. Dtsch Med Wochenschr 1998; 123: 1439-1442
- 16 Knecht GL, Kozarek RA. Double-channel fistulotome for endoscopic drainage of pancreatic pseudocyst. Gastrointest Endosc 1991; 37: 356-357
- 17 Sharaiha RZ, DeFilippis EM, Kedia P. et al. Metal versus plastic for pancreatic pseudocyst drainage: clinical outcomes and success. Gastrointest Endosc 2015; 82: 822-827
- 18 Banks PA, Bollen TL, Dervenis C. et al. Classification of acute pancreatitis--2012: revision of the Atlanta classification and definitions by international consensus. Gut 2013; 62: 102-111
- 19 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
- 20 Ge N, Hu J, Sun S. et al. Endoscopic ultrasound-guided pancreatic pseudocyst drainage with lumen-apposing metal stents or plastic double-pigtail stents: a multifactorial analysis. J Transl Int Med 2017; 5: 213-219
- 21 Bang JY, Hawes R, Bartolucci A. et al. Efficacy of metal and plastic stents for transmural drainage of pancreatic fluid collections: a systematic review. Dig Endosc 2015; 27: 486-498
- 22 Seifert H, Biermer M, Schmitt W. et al. Transluminal endoscopic necrosectomy after acute pancreatitis: a multicentre study with long-term follow-up (the GEPARD Study). Gut 2009; 58: 1260-1266
- 23 Bang JY, Wilcox CM, Trevino JM. et al. Relationship between stent characteristics and treatment outcomes in endoscopic transmural drainage of uncomplicated pancreatic pseudocysts. Surg Endosc 2014; 28: 2877-2883
- 24 Talreja JP, Shami VM, Ku J. et al. Transenteric drainage of pancreatic-fluid collections with fully covered self-expanding metallic stents (with video). Gastrointest Endosc 2008; 68: 1199-1203
- 25 Fabbri C, Luigiano C, Cennamo V. et al. Endoscopic ultrasound-guided transmural drainage of infected pancreatic fluid collections with placement of covered self-expanding metal stents: a case series. Endoscopy 2012; 44: 429-433
- 26 Siddiqui AA, Kowalski TE, Loren DE. et al. Fully covered self-expanding metal stents versus lumen-apposing fully covered self-expanding metal stent versus plastic stents for endoscopic drainage of pancreatic walled-off necrosis: clinical outcomes and success. Gastrointest Endosc 2017; 85: 758-765
- 27 Varadarajulu S, Bang JY, Phadnis MA. et al. Endoscopic transmural drainage of peripancreatic fluid collections: outcomes and predictors of treatment success in 211 consecutive patients. J Gastrointest Surg 2011; 15: 2080-2088
- 28 Penn DE, Draganov PV, Wagh MS. et al. Prospective evaluation of the use of fully covered self-expanding metal stents for EUS-guided transmural drainage of pancreatic pseudocysts. Gastrointest Endosc 2012; 76: 679-684
- 29 Ang TL, Kongkam P, Kwek AB. et al. A two-center comparative study of plastic and lumen-apposing large diameter self-expandable metallic stents in endoscopic ultrasound-guided drainage of pancreatic fluid collections. Endosc Ultrasound 2016; 5: 320-327
- 30 Ang TL, Seewald S. Fully covered self-expandable metal stents: The “be all and end all” for pancreatic fluid collections?. Gastrointest Endosc 2015; 82: 1047-1050
- 31 Itoi T, Binmoeller KF, Shah J. et al. Clinical evaluation of a novel lumen-apposing metal stent for endosonography-guided pancreatic pseudocyst and gallbladder drainage (with videos). Gastrointest Endosc 2012; 75: 870-876
- 32 Moon JH, Choi HJ, Kim DC. et al. A newly designed fully covered metal stent for lumen apposition in EUS-guided drainage and access: a feasibility study (with videos). Gastrointest Endosc 2014; 79: 990-995
- 33 Varadarajulu S, Wilcox CM. Endoscopic placement of permanent indwelling transmural stents in disconnected pancreatic duct syndrome: does benefit outweigh the risks?. Gastrointest Endosc 2011; 74: 1408-1412
- 34 Antillon MR, Shah RJ, Stiegmann G. et al. Single-step EUS-guided transmural drainage of simple and complicated pancreatic pseudocysts. Gastrointest Endosc 2006; 63: 797-803
- 35 Lee BU, Song TJ, Lee SS. et al. Newly designed, fully covered metal stents for endoscopic ultrasound (EUS)-guided transmural drainage of peripancreatic fluid collections: a prospective randomized study. Endoscopy 2014; 46: 1078-1084
- 36 Bang JY, Hasan MK, Navaneethan U. et al. Lumen-apposing metal stents for drainage of pancreatic fluid collections: When and for whom?. Dig Endosc 2017; 29: 83-90
- 37 Lang GD, Fritz C, Bhat T. et al. EUS-guided drainage of peripancreatic fluid collections with lumen-apposing metal stents and plastic double-pigtail stents: comparison of efficacy and adverse event rates. Gastrointest Endosc 2018; 87: 150-157
- 38 Brimhall B, Han S, Tatman PD. et al. Increased incidence of pseudoaneurysm bleeding with lumen-apposing metal stents compared to double-pigtail plastic stents in patients with peripancreatic fluid collections. Clin Gastroenterol Hepatol 2018; 16: 1521-1528
- 39 Patil R, Ona MA, Papafragkakis C. et al. Endoscopic ultrasound-guided placement of AXIOS stent for drainage of pancreatic fluid collections. Ann Gastroenterol 2016; 29: 168-173
- 40 Vazquez-Sequeiros E, Baron TH, Pérez-Miranda M. et al. Evaluation of the short- and long-term effectiveness and safety of fully covered self-expandable metal stents for drainage of pancreatic fluid collections: results of a Spanish nationwide registry. Gastrointestinal Endoscopy 2016; 84: 450-457.e2
- 41 Bang JY, Hasan M, Navaneethan U. et al. Lumen-apposing metal stents (LAMS) for pancreatic fluid collection (PFC) drainage: may not be business as usual. Gut 2017; 66: 2054-2056
- 42 Rinninella E, Kunda R, Dollhopf M. et al. EUS-guided drainage of pancreatic fluid collections using a novel lumen-apposing metal stent on an electrocautery-enhanced delivery system: a large retrospective study (with video). Gastrointest Endosc 2015; 82: 1039-1046
- 43 Ryan BM, Venkatachalapathy SV, Huggett MT. Safety of lumen-apposing metal stents (LAMS) for pancreatic fluid collection drainage. Gut 2017; 66: 1530-1531
- 44 Leeds JS, Nayar MK, Charnley RM. et al. Lumen-apposing metal stents for pancreatic fluid collection drainage: may not be business as usual?. Gut 2017; 66: 1530
- 45 Siddiqui AA, Adler DG, Nieto J. et al. EUS-guided drainage of peripancreatic fluid collections and necrosis by using a novel lumen-apposing stent: a large retrospective, multicenter U. S. experience (with videos). Gastrointest Endosc 2016; 83: 699-707
- 46 Cotton PB, Eisen G, Romagnuolo J. et al. Grading the complexity of endoscopic procedures: results of an ASGE working party. Gastrointest Endosc 2011; 73: 868-874
- 47 Ng SC, Tsoi KK, Hirai HW. et al. The efficacy of cap-assisted colonoscopy in polyp detection and cecal intubation: a meta-analysis of randomized controlled trials. Am J Gastroenterol 2012; 107: 1165-1173
- 48 Fabbri C, Luigiano C, Maimone A. et al. Endoscopic ultrasound-guided drainage of pancreatic fluid collections. World J Gastrointest Endosc 2012; 4: 479-488
Corresponding author
-
References
- 1 Poornachandra KS, Bhasin DK, Nagi B. et al. Clinical, biochemical, and radiologic parameters at admission predicting formation of a pseudocyst in acute pancreatitis. J Clin Gastroenterol 2011; 45: 159-163
- 2 Tyberg A, Karia K, Gabr M. et al. Management of pancreatic fluid collections: A comprehensive review of the literature. World J Gastroenterol 2016; 22: 2256-2270
- 3 Maringhini A, Uomo G, Patti R. et al. Pseudocysts in acute nonalcoholic pancreatitis: incidence and natural history. Dig Dis Sci 1999; 44: 1669-1673
- 4 Nealon WH, Bhutani M, Riall TS. et al. A unifying concept: pancreatic ductal anatomy both predicts and determines the major complications resulting from pancreatitis. J Am Coll Surg 2009; 208: 790-799 ; discussion 799–801
- 5 Singhal S, Rotman SR, Gaidhane M. et al. Pancreatic fluid collection drainage by endoscopic ultrasound: an update. Clin Endosc 2013; 46: 506-514
- 6 Kahaleh M, Shami VM, Conaway MR. et al. Endoscopic ultrasound drainage of pancreatic pseudocyst: a prospective comparison with conventional endoscopic drainage. Endoscopy 2006; 38: 355-259
- 7 Shah RJ, Shah JN, Waxman I. et al. Safety and efficacy of endoscopic ultrasound-guided drainage of pancreatic fluid collections with lumen-apposing covered self-expanding metal stents. Clin Gastroenterol Hepatol 2015; 13: 747-752
- 8 Baron TH, Harewood GC, Morgan DE. et al. Outcome differences after endoscopic drainage of pancreatic necrosis, acute pancreatic pseudocysts, and chronic pancreatic pseudocysts. Gastrointest Endosc 2002; 56: 7-17
- 9 Sharaiha RZ, Tyberg A, Khashab MA. et al. Endoscopic therapy with lumen-apposing metal stents is safe and effective for patients with pancreatic walled-off necrosis. Clin Gastroenterol Hepatol 2016; 14: 1797-1803
- 10 Varadarajulu S, Bang JY, Sutton BS. et al. Equal efficacy of endoscopic and surgical cystogastrostomy for pancreatic pseudocyst drainage in a randomized trial. Gastroenterology 2013; 145: 583-590.e1
- 11 Varadarajulu S, Lopes TL, Wilcox CM. et al. EUS versus surgical cyst-gastrostomy for management of pancreatic pseudocysts. Gastrointest Endosc 2008; 68: 649-655
- 12 Teoh AY, Dhir V, Jin ZD. et al. Systematic review comparing endoscopic, percutaneous and surgical pancreatic pseudocyst drainage. World J Gastrointest Endosc 2016; 8: 310-318
- 13 Giovannini M. Endoscopic ultrasound-guided pancreatic pseudocyst drainage. Gastrointest Endosc Clin N Am 2005; 15: 179-188, xi
- 14 Parks RW, Tzovaras G, Diamond T. et al. Management of pancreatic pseudocysts. Ann R Coll Surg Engl 2000; 82: 383-387
- 15 Pfaffenbach B, Langer M, Stabenow-Lohbauer U. et al. [Endosonography controlled transgastric drainage of pancreatic pseudocysts]. Dtsch Med Wochenschr 1998; 123: 1439-1442
- 16 Knecht GL, Kozarek RA. Double-channel fistulotome for endoscopic drainage of pancreatic pseudocyst. Gastrointest Endosc 1991; 37: 356-357
- 17 Sharaiha RZ, DeFilippis EM, Kedia P. et al. Metal versus plastic for pancreatic pseudocyst drainage: clinical outcomes and success. Gastrointest Endosc 2015; 82: 822-827
- 18 Banks PA, Bollen TL, Dervenis C. et al. Classification of acute pancreatitis--2012: revision of the Atlanta classification and definitions by international consensus. Gut 2013; 62: 102-111
- 19 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
- 20 Ge N, Hu J, Sun S. et al. Endoscopic ultrasound-guided pancreatic pseudocyst drainage with lumen-apposing metal stents or plastic double-pigtail stents: a multifactorial analysis. J Transl Int Med 2017; 5: 213-219
- 21 Bang JY, Hawes R, Bartolucci A. et al. Efficacy of metal and plastic stents for transmural drainage of pancreatic fluid collections: a systematic review. Dig Endosc 2015; 27: 486-498
- 22 Seifert H, Biermer M, Schmitt W. et al. Transluminal endoscopic necrosectomy after acute pancreatitis: a multicentre study with long-term follow-up (the GEPARD Study). Gut 2009; 58: 1260-1266
- 23 Bang JY, Wilcox CM, Trevino JM. et al. Relationship between stent characteristics and treatment outcomes in endoscopic transmural drainage of uncomplicated pancreatic pseudocysts. Surg Endosc 2014; 28: 2877-2883
- 24 Talreja JP, Shami VM, Ku J. et al. Transenteric drainage of pancreatic-fluid collections with fully covered self-expanding metallic stents (with video). Gastrointest Endosc 2008; 68: 1199-1203
- 25 Fabbri C, Luigiano C, Cennamo V. et al. Endoscopic ultrasound-guided transmural drainage of infected pancreatic fluid collections with placement of covered self-expanding metal stents: a case series. Endoscopy 2012; 44: 429-433
- 26 Siddiqui AA, Kowalski TE, Loren DE. et al. Fully covered self-expanding metal stents versus lumen-apposing fully covered self-expanding metal stent versus plastic stents for endoscopic drainage of pancreatic walled-off necrosis: clinical outcomes and success. Gastrointest Endosc 2017; 85: 758-765
- 27 Varadarajulu S, Bang JY, Phadnis MA. et al. Endoscopic transmural drainage of peripancreatic fluid collections: outcomes and predictors of treatment success in 211 consecutive patients. J Gastrointest Surg 2011; 15: 2080-2088
- 28 Penn DE, Draganov PV, Wagh MS. et al. Prospective evaluation of the use of fully covered self-expanding metal stents for EUS-guided transmural drainage of pancreatic pseudocysts. Gastrointest Endosc 2012; 76: 679-684
- 29 Ang TL, Kongkam P, Kwek AB. et al. A two-center comparative study of plastic and lumen-apposing large diameter self-expandable metallic stents in endoscopic ultrasound-guided drainage of pancreatic fluid collections. Endosc Ultrasound 2016; 5: 320-327
- 30 Ang TL, Seewald S. Fully covered self-expandable metal stents: The “be all and end all” for pancreatic fluid collections?. Gastrointest Endosc 2015; 82: 1047-1050
- 31 Itoi T, Binmoeller KF, Shah J. et al. Clinical evaluation of a novel lumen-apposing metal stent for endosonography-guided pancreatic pseudocyst and gallbladder drainage (with videos). Gastrointest Endosc 2012; 75: 870-876
- 32 Moon JH, Choi HJ, Kim DC. et al. A newly designed fully covered metal stent for lumen apposition in EUS-guided drainage and access: a feasibility study (with videos). Gastrointest Endosc 2014; 79: 990-995
- 33 Varadarajulu S, Wilcox CM. Endoscopic placement of permanent indwelling transmural stents in disconnected pancreatic duct syndrome: does benefit outweigh the risks?. Gastrointest Endosc 2011; 74: 1408-1412
- 34 Antillon MR, Shah RJ, Stiegmann G. et al. Single-step EUS-guided transmural drainage of simple and complicated pancreatic pseudocysts. Gastrointest Endosc 2006; 63: 797-803
- 35 Lee BU, Song TJ, Lee SS. et al. Newly designed, fully covered metal stents for endoscopic ultrasound (EUS)-guided transmural drainage of peripancreatic fluid collections: a prospective randomized study. Endoscopy 2014; 46: 1078-1084
- 36 Bang JY, Hasan MK, Navaneethan U. et al. Lumen-apposing metal stents for drainage of pancreatic fluid collections: When and for whom?. Dig Endosc 2017; 29: 83-90
- 37 Lang GD, Fritz C, Bhat T. et al. EUS-guided drainage of peripancreatic fluid collections with lumen-apposing metal stents and plastic double-pigtail stents: comparison of efficacy and adverse event rates. Gastrointest Endosc 2018; 87: 150-157
- 38 Brimhall B, Han S, Tatman PD. et al. Increased incidence of pseudoaneurysm bleeding with lumen-apposing metal stents compared to double-pigtail plastic stents in patients with peripancreatic fluid collections. Clin Gastroenterol Hepatol 2018; 16: 1521-1528
- 39 Patil R, Ona MA, Papafragkakis C. et al. Endoscopic ultrasound-guided placement of AXIOS stent for drainage of pancreatic fluid collections. Ann Gastroenterol 2016; 29: 168-173
- 40 Vazquez-Sequeiros E, Baron TH, Pérez-Miranda M. et al. Evaluation of the short- and long-term effectiveness and safety of fully covered self-expandable metal stents for drainage of pancreatic fluid collections: results of a Spanish nationwide registry. Gastrointestinal Endoscopy 2016; 84: 450-457.e2
- 41 Bang JY, Hasan M, Navaneethan U. et al. Lumen-apposing metal stents (LAMS) for pancreatic fluid collection (PFC) drainage: may not be business as usual. Gut 2017; 66: 2054-2056
- 42 Rinninella E, Kunda R, Dollhopf M. et al. EUS-guided drainage of pancreatic fluid collections using a novel lumen-apposing metal stent on an electrocautery-enhanced delivery system: a large retrospective study (with video). Gastrointest Endosc 2015; 82: 1039-1046
- 43 Ryan BM, Venkatachalapathy SV, Huggett MT. Safety of lumen-apposing metal stents (LAMS) for pancreatic fluid collection drainage. Gut 2017; 66: 1530-1531
- 44 Leeds JS, Nayar MK, Charnley RM. et al. Lumen-apposing metal stents for pancreatic fluid collection drainage: may not be business as usual?. Gut 2017; 66: 1530
- 45 Siddiqui AA, Adler DG, Nieto J. et al. EUS-guided drainage of peripancreatic fluid collections and necrosis by using a novel lumen-apposing stent: a large retrospective, multicenter U. S. experience (with videos). Gastrointest Endosc 2016; 83: 699-707
- 46 Cotton PB, Eisen G, Romagnuolo J. et al. Grading the complexity of endoscopic procedures: results of an ASGE working party. Gastrointest Endosc 2011; 73: 868-874
- 47 Ng SC, Tsoi KK, Hirai HW. et al. The efficacy of cap-assisted colonoscopy in polyp detection and cecal intubation: a meta-analysis of randomized controlled trials. Am J Gastroenterol 2012; 107: 1165-1173
- 48 Fabbri C, Luigiano C, Maimone A. et al. Endoscopic ultrasound-guided drainage of pancreatic fluid collections. World J Gastrointest Endosc 2012; 4: 479-488