|Year : 2015 | Volume
| Issue : 3 | Page : 213-218
Endoscopic drainage of pancreatic fluid collections using a fully covered expandable metal stent with antimigratory fins
Isaac Raijman1, Paul R Tarnasky2, Sandeep Patel3, Douglas S Fishman4, Sri Naveen Surapaneni3, Laura Rosenkranz3, Jayant P Talreja5, Dang Nguyen1, Monica Gaidhane6, Michel Kahaleh6
1 Digestive Associates of Houston, Houston, Texas, USA
2 Methodist Hospital, Dallas, Texas, USA
3 University of Texas Health Science Center, San Antonio, Texas, USA
4 Texas Children Hospital, Houston, Texas, USA
5 University of Virginia, Charlottesville, Virginia, USA
6 Division of Gastroenterology and Hepatology, Weill Cornell Medical College, New York, USA
|Date of Submission||16-Jul-2014|
|Date of Acceptance||23-Sep-2014|
|Date of Web Publication||17-Aug-2015|
Dr. Michel Kahaleh
Division of Gastroenterology and Hepatology, Weill Cornell Medical College, New York
Source of Support: None, Conflict of Interest: Michel Kahaleh MD
has received grant support from Boston Scientific, Fujinon, EMcison,
Xlumena Inc., MaunaKea, Apollo Endosurgery, ASPIRE Bariatrics, W.l.
Gore, Cook, GIDynamics and MI Tech. He is a consultant for Boston
Scientific, Concordia and Xlumena Inc. All other authors have no
conflicts of interest to report.
Background and Objectives: Endoscopic drainage is the first consideration in treating pancreatic fluid collections (PFCs). Recent data suggests it may be useful in complicated PFCs as well. Most of the available data assess the use of plastic stents, but scarce data exists on metal stent management of PFCs. The aim of our study to evaluate the efficacy and safety of a metal stent in the management of PFCs. Patients and Methods: Data were collected prospectively on 47 patients diagnosed with PFCs from March 2007 to August 2011 at 3 tertiary care centers. These patients underwent endoscopic transmural placement of a fully covered self-expanding metal stent (FCSEMS) with antimigratory fins of 10 mm diameter. Results: The stent was successfully placed in all patients, and left in place an average of 13 weeks (range 0.4-36 weeks). Etiology of the PFC was biliary pancreatitis (23), pancreas divisum (2), trauma (4), hyperlipidemia (3), alcoholic (8), smoking (2), idiopathic (4), and medication-induced (1). PFCs resolved in 36 patients, for an overall success rate of 77%. Complications included fever (3), stent migration (2) and abdominal pain (1). Conclusions: The use of FCSEMS is successful in the majority of patients with low complication rates. A large sample-sized RCT is needed to confirm if the resolution of PFCs is long-standing.
Keywords: Endoscopy, fully covered self-expanding metal stent with antimigratory fins, pancreatic fluid collections, transmural
|How to cite this article:|
Raijman I, Tarnasky PR, Patel S, Fishman DS, Surapaneni SN, Rosenkranz L, Talreja JP, Nguyen D, Gaidhane M, Kahaleh M. Endoscopic drainage of pancreatic fluid collections using a fully covered expandable metal stent with antimigratory fins. Endosc Ultrasound 2015;4:213-8
|How to cite this URL:|
Raijman I, Tarnasky PR, Patel S, Fishman DS, Surapaneni SN, Rosenkranz L, Talreja JP, Nguyen D, Gaidhane M, Kahaleh M. Endoscopic drainage of pancreatic fluid collections using a fully covered expandable metal stent with antimigratory fins. Endosc Ultrasound [serial online] 2015 [cited 2019 Aug 25];4:213-8. Available from: http://www.eusjournal.com/text.asp?2015/4/3/213/163000
| Introduction|| |
Pancreatic fluid collections (PFCs) encompass acute peripancreatic fluid collection with solid component, pseudocyst, post-necrotic PFC; and walled-off pancreatic necrosis (WOPN). ,
Pancreatic pseudocysts (PC) usually originate as a complication of an edematous interstitial pancreatitis, a lesion characterized by pancreatic juice that is enclosed within a circumscribed wall of non-epithelialized, fibrous, or granulation tissue, and no necrosis associated.  WOPN emerges 2-6 weeks after the onset of pancreatitis and contain liquid and necrotic detritus. ,,
Majority of the pseudocysts resolve spontaneously or through conservative treatment. However, some symptomatic or enlarging pseudocysts require drainage to avoid complications. ,
The principal indications for drainage are symptoms, complications or rapid increase in diameter of the fluid collection. ,
Contemporary drainage options include surgical, percutaneous and endoscopic modalities.  Surgical treatment was the gold standard for drainage, but is also associated with elevated morbidity between 7% and 37% and mortality of 6%,  while percutaneous drainage depends on an external catheter, which increases the risk of infection or the formation of a cutaneous fistula. ,
With the advent of endoscopy, there has been a major increase in the number of patients undergoing endoscopic drainage since it has been shown to be efficacious and minimally invasive, and hence has become the first preference in treating uncomplicated PFC.  Endoscopic drainage can be transpapillary, transmural or both. Transpapillary drainage is now rarely used for small pseudocysts, which communicates with the pancreatic duct. , Transmural drainage can be done via a transgastric or transduodenal approach; ,, which is preeminent for big, infected or collections with necrotic elements.  Transmural pseudocyst drainage has median rates of 93.8%, 87.5%, 16.9%, 7.5% for technical success, clinical success, complications and recurrence, respectively. ,,,,
Generally, multiple plastic stents are placed for transmural drainage of pseudocysts. However, these stents have a narrow diameter and frequently occlude necessitating repeat stent exchanges or placement of additional stents. 
Fully covered self-expanding metallic stents (FCSEMS) have a larger diameter compared to plastic stents. Their advantages might lead to a reduced number of procedures because of longer patency and larger diameter dilation, which results in a shorter period of resolution (6 weeks) , and reduced morbidity rates.
Penn et al. recently reported the combined use of Wallflex stent (FCSEMS, Boston Scientific, MA, USA) and plastic pigtail stents for the treatment of simple pseudocysts. A single 10F or 7F double pigtail biliary stent was placed through the FCSEMS with the internal pigtail inside the cyst cavity and the external pigtail in the GI lumen, to anchor the FCSEMS and reduce the risk of migration. 
We evaluated the use of Viabil stents (FCSEMS) composed of nitinol and covered by Gore-Tex expanded polytetrafluoroethylene because it has anchoring fins to prevent migration. ,,,,
The aim of this study was to assess the safety and efficacy of FCSEMS for the management of simple pancreatic pseudocysts,  and WOPN.
| Patients and Methods|| |
Between March 2007 and August 2011, data were collected on 47 patients (29 males, mean age of 59.2 ± 14.8 years) from 3 academic medical centers (University of Virginia, Digestive Associates of Houston, Houston, Texas, Methodist Hospital, Dallas, Texas) with symptomatic PFCs (4 weeks or more) underwent endoscopic transmural drainage with FCSEMS (Viabil, Conmed, Utica) placement. Symptoms included pain, infection, gastric outlet obstruction, etc. Patients were included from established prospective database registries based on the following inclusion criteria:
Exclusion criteria included:
- Symptomatic and drainable PFCs (pseudocyst or WOPN).
- Eligible for endoscopic intervention.
- Poorly organized PFC,
- Abnormal coagulation, and
- Cystic neoplasm.
A single FCSEMS of 10 mm diameter and 6-8 cm in length were placed in all 47 subjects. FCSEMS of 10 mm diameter and 8 cm in length were placed in patients with PFC equal to or larger than 8 cm. All subjects had a history of either acute (n = 37) or chronic pancreatitis (n = 10).
A singular endoscopy session was conducted during which transmural drainage was conducted with the aid of fluoroscopy. The pancreatic duct was evaluated using a pancreatogram for leaks or obstructions and stented if needed, during the same session.
Endoscopic ultrasound (EUS) was used in all but two patients. After size localization and color flow Doppler to assess intervening vasculature, puncture of the fluid collection was performed, and an aspirate sent for culture [Figure 1]. A 19 gauge EUS needle was used to puncture the cavity in 45 patients, and a 10 French cystoenterotome for the remaining two. Balloon dilation of the tract was conducted up to 6-8 mm and a guidewire was coiled into the pseudocyst. The FCSEMS was then deployed into the cavity over the guidewire [Figure 2]. The endoscope was removed after drainage was observed through the FCSEMS [Figure 3] and [Figure 4]. Thirteen double pigtail stents were placed through the Viabil stent.
The majority of the stents were placed on an outpatient basis (n = 25), and the procedure performed under propofol sedation or general anesthesia, all with antibiotics coverage.
|Figure 3 . Endoscopic image of drainage visualization post stent placement|
Click here to view
|Figure 4. Computed tomography image showing the stent placed with resolution of the pancreatic fluid collection|
Click here to view
Institutional review board approval was obtained prior to enrollment and analyses (IRB# 13408, approved on 12/06/2007).
The following variables were collected and considered for both descriptive and analytical statistics: Demographics, etiology, presence or absence of necrosis, dimensions and type of pseudocyst, location of the PFC, puncture site, stent indwelling time, resolution duration, and any complications after stent placement and/or removal. Pancreatogram findings were also collected.
Technical success was based on the successful placement of the FCSEMS through the cavity with appropriate fluoroscopic position. Any complications within 24 h were considered immediate, within 30 days as early complications and late if they occurred after 30 days.
Clinical success was defined as resolution of the PFCs based on the CT or EUS imaging within without the need for surgical, percutaneous or repeat endoscopic drainage.
Logistic regression was conducted using SAS 9.2 (SAS Institute Inc., Cary, NC, USA) to report the predictive factors for success or failure of resolution.
| Results|| |
Forty-seven patients (29 males) diagnosed with PFCs were included in a multicenter study from March 2007 to August 2011. Mean age was 49 years (range 17-77 years). Acute pancreatitis occurred in 37, chronic pancreatitis in 10. The PFC was located in the tail in 10, body in 24, head in 8 and body/tail in 5 [Table 1].
|Table 1. Characteristics of patients treated for pancreatic pseudocysts (n = 47) |
Click here to view
Nine subjects had WOPN, while four subjects had infected WOPN.
Four patients had a nasocystic drains placed, and four patients underwent concomitant percutaneous drainage immediately prior to cystenterostomy in cases of extensive necrotic material to provide the ability for flushing similar to the approach reported in Gluck et al.  11 had double pigtail stents placed through the Viabil stent, three had two pigtail stents placed.
The FCSEMS was successfully placed in all patients. The stent was placed on an average of 14 weeks (0.5-56 weeks) after symptom onset. The PFC was simple in 34, complex in 13, with a mean diameter of 14.3 cm (7-30 cm). The etiology of the PC was biliary pancreatitis in 23, pancreas divisum in 2, trauma in 4, hyperlipidemia in 3, alcoholic in 8, smoking in 2, idiopathic in 3, and medication-induced in 1.
Pancreatogram in 25 patients revealed a disconnected duct in 10, obstruction in 8 and PD disruption in 2. A pancreatic duct stent was placed in 20 patients, bridging a leak or treating a stricture. Eleven patients had a pancreatic duct leak which was treated prior to PFC drainage with a pancreatic stent placed for 8-10 weeks.
The metal stent for PFC drainage was placed trans-gastrically in 44 patients and trans-duodenally in 3. The stent was left in place an average of 13 weeks (range 0.4-36 weeks). Mean follow-up was 52 weeks (3-180 weeks).
The PFC resolved in 36/47 patients, for an overall success rate of 77%. The success for simple PFC was 79% (27/34) whereas for complex PFC was 69% (9/13). There has not been PFC recurrence in those with the initial resolution after an average observation time of 20 weeks (4-27 weeks).
Six of the failed patients developed an abscess and sepsis requiring surgical drainage, two patients required further endoscopic drainage session and two patients were lost to follow-up (considered a failure). One subject had the metal stent replaced to facilitate endoscopic necrosectomy. Placing plastic stents through the Viabil stent was neither beneficial nor detrimental. One patient had a stent in place for 56 weeks as removal was possible due to cardiac comorbidities (coronary stent placement and anticoagulation) rendering the patient unable to undergo stent removal endoscopy. Of the failed patients, seven had a simple PFC while four had a complex PFC.
Complications included migrations (2), fever (3), and abdominal pain (1). One patient with migrated stent had a very complicated course with bleeding from a pseudoaneurysm and required debridement, with the creation of two additional sites of puncture. One subject had both fever and abdominal pain. Their stent was removed and replaced with a 10F × 6 cm plastic stent. Two subjects with high fever were admitted and underwent surgical drainage.
The addition of plastic pigtail stents in 11 subjects had no effect on migration rates, and was neither beneficial nor detrimental to the safety and efficacy of metal stent management of PFCs.
Logistic regression was conducted to determine if age, gender, etiology, symptom onset to the drainage duration, type of pancreatitis, and location and size of PFC were predictive factors for success or failure of resolution. After adjusting for confounders, none of the above increased or decreased the odds for PFC resolution success [Table 2].
| Discussion|| |
Endoscopic drainage of PFCs has been adopted by most tertiary centers. ,,,,, It offers a safe and minimally invasive alternative to surgery and percutaneous drainage, which are associated with increased morbidity and mortality in this specific indication.  Plastic stents are typically placed to create the open conduits between the stomach/intestine and the PFC. ,, However, the necessity to place many stents to offer the maximal drainage in a least amount of session has led us to seek other options.
The success of expandable metal stent in providing better biliary decompression than plastic stent led to their utilization in PFC. ,,,,,,
Penn et al. reported that efficacy was achieved by placing pigtail stents through metal stents (Wallflex, Boston Scientific, Natick, MA, USA) by preventing migration and allowing for drainage along the length of the plastic pigtail stents. Our study demonstrates that is not necessary to place a double pigtail into the FCSEMS to prevent migration. However, they used a different stent, which has a similar design, but doesn't have the anti-migratory fins. 
In our study, the pancreatic duct was evaluated, and stents were placed (if needed) in the same endoscopic session of the transmural drainage. With no subsequent recurrence of PFC, we, therefore, believe that diagnosing and treating pancreatic duct disruption does indeed decrease the risk of recurrence.
Treatment success was more likely for patients with simple PFC (pseudocyst) than in complex ones (necrosis). WOPN, due to the need to perform many debridement sessions require the placement of larger than 10 mm metal stent, permitting the insertion of an upper endoscopy. 
Despite having a larger sample size, our study has some limitations. Our study had a single cohort of patients, with no control arm or randomization. To confirm and verify the results, we must conduct a randomized trial with two or more arms to compare metal stents with antimigratory fins to conventional placement of plastic pigtail stents; as well as metals stents without antimigratory fins. A multicenter study would ensure large accrual, and help compare if FCSEMSs are indeed superior to plastic pigtail stents.
| Conclusion|| |
The use of FCSEMS with antimigratory fins is successful in the majority of patients with simple PFC while its efficacy diminishes in patients with necrosis. A large randomized trial comparing this metal stent to plastic pigtail stent in this patient population is needed.
| References|| |
Banks PA, Bollen TL, Dervenis C, Gooszen HG, et al
. Classification of acute pancreatitis - 2012: Revision of the Atlanta classification and definitions by international consensus. Gut
Morgan DE. Nomenclature revision. Clin Gastroenterol Hepatol
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
Hookey LC, Debroux S, Delhaye M, et al
. Endoscopic drainage of pancreatic-fluid collections in 116 patients: A comparison of etiologies, drainage techniques, and outcomes. Gastrointest Endosc
Varadarajulu S, Phadnis MA, Christein JD, et al
. Multiple transluminal gateway technique for EUS-guided drainage of symptomatic walled-off pancreatic necrosis. Gastrointest Endosc
Raijman I. Biliary and pancreatic stents. Gastrointest Endosc Clin N Am
Varadarajulu S, Christein JD, Wilcox CM. Frequency of complications during EUS-guided drainage of pancreatic fluid collections in 148 consecutive patients. J Gastroenterol Hepatol
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
Voermans RP, Fockens P. Endoscopic treatment of pancreatic fluid collections in 2008 and beyond. Gastrointest Endosc
Varadarajulu S, Wilcox CM. Endoscopic placement of permanent indwelling transmural stents in disconnected pancreatic duct syndrome: Does benefit outweigh the risks? Gastrointest Endosc
Kahaleh M, Hernandez AJ, Tokar J, et al
. EUS-guided pancreaticogastrostomy: Analysis of its efficacy to drain inaccessible pancreatic ducts. Gastrointest Endosc
Varadarajulu S, Trevino JM. Review of EUS-guided pancreatic duct drainage (with video). Gastrointest Endosc
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
Giovannini M, Bernardini D, Seitz JF. Cystogastrotomy entirely performed under endosonography guidance for pancreatic pseudocyst: Results in six patients. Gastrointest Endosc
Krüger M, Schneider AS, Manns MP, et al
. Endoscopic management of pancreatic pseudocysts or abscesses after an EUS-guided 1-step procedure for initial access. Gastrointest Endosc
Cremer M, Deviere J, Engelholm L. Endoscopic management of cysts and pseudocysts in chronic pancreatitis: Long-term follow-up after 7 years of experience. Gastrointest Endosc
Catalano MF, Geenen JE, Schmalz MJ, et al
. Treatment of pancreatic pseudocysts with ductal communication by transpapillary pancreatic duct endoprosthesis. Gastrointest Endosc
ASGE Technology Committee, Varadarajulu S, Banerjee S, et al
. Enteral stents. Gastrointest Endosc
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
Srinivasan I, Kahaleh M. Biliary stents in the millennium. Adv Ther
Bakhru MR, Foley PL, Gatesman J, et al
. Fully covered self-expanding metal stents placed temporarily in the bile duct: Safety profile and histologic classification in a porcine model. BMC Gastroenterol
Varadarajulu S, Trevino JM, Christein JD. EUS for the management of peripancreatic fluid collections after distal pancreatectomy. Gastrointest Endosc
Sauer B, Talreja J, Ellen K, et al
. Temporary placement of a fully covered self-expandable metal stent in the pancreatic duct for management of symptomatic refractory chronic pancreatitis: Preliminary data (with videos). Gastrointest Endosc
Gluck M, Ross A, Irani S, et al.
Endoscopic and percutaneous drainage of symptomatic walled-off pancreatic necrosis reduces hospital stay and radiographic resources. Clin Gastroenterol Hepatol
Binmoeller KF, Seifert H, Walter A, et al
. Transpapillary and transmural drainage of pancreatic pseudocysts. Gastrointest Endosc
Cahen D, Rauws E, Fockens P, et al
. Endoscopic drainage of pancreatic pseudocysts: Long-term outcome and procedural factors associated with safe and successful treatment. Endoscopy
Varadarajulu S, Christein JD, Tamhane A, et al
. Prospective randomized trial comparing EUS and EGD for transmural drainage of pancreatic pseudocysts (with videos). Gastrointest Endosc
Seewald S, Ang TL, Kida M, et al
. EUS 2008 Working Group document: Evaluation of EUS-guided drainage of pancreatic-fluid collections (with video). Gastrointest Endosc
Varadarajulu S, Wilcox CM, Christein JD. EUS-guided therapy for management of peripancreatic fluid collections after distal pancreatectomy in 20 consecutive patients. Gastrointest Endosc
Kahaleh M, Shami VM, Conaway MR, et al.
Endoscopic ultrasound drainage of pancreatic pseudocyst: A prospective comparison with conventional endoscopic drainage. Endoscopy
Delhaye M, Matos C, Devière J. Endoscopic management of chronic pancreatitis. Gastrointest Endosc Clin N Am
Lopes CV, Pesenti C, Bories E, et al
. Endoscopic-ultrasound-guided endoscopic transmural drainage of pancreatic pseudocysts and abscesses. Scand J Gastroenterol
Soderlund C, Linder S. Covered metal versus plastic stents for malignant common bile duct stenosis: A prospective, randomized, controlled trial. Gastrointest Endosc
Kaassis M, Boyer J, Dumas R, et al.
Plastic or metal stents for malignant stricture of the common bile duct? Results of a randomized prospective study. Gastrointest Endosc
Kahaleh M, Tokar J, Conaway MR, et al.
Efficacy and complications of covered Wallstents in malignant distal biliary obstruction. Gastrointest Endosc
Gerolami R, Giovannini M, Laugier R. Endoscopic drainage of pancreatic pseudocysts guided by endosonography. Endoscopy
Pop GH, Richter JA, Sauer B, et al.
Bridge to surgery using partially covered self-expandable metal stents (PCMS) in malignant biliary stricture: An acceptable paradigm? Surg Endosc
Sarkaria S, Rondon C, Srinivasan I, et al
. Su1390 Pancreatic necrosectomy using a fully covered esophageal stent combined with percutaneous endoscopic gastrostomy and jejunal ARM placement: A synergistic approach. AB315 Gastrointest Endosc
[Figure 1], [Figure 2], [Figure 3], [Figure 4]
[Table 1], [Table 2]
|This article has been cited by|
||Systematic Review of Endoscopic Cyst Gastrostomy
| ||Steven Shamah,Patrick I. Okolo |
| ||Gastrointestinal Endoscopy Clinics of North America. 2018; |
|[Pubmed] | [DOI]|
||The treatment indication and optimal management of fluid collection after laparoscopic distal pancreatectomy
| ||Ki Byung Song,Jaewoo Kwon,Young-Joo Lee,Dae Wook Hwang,Jae Hoon Lee,Sang Hyun Shin,Myung-Hwan Kim,Sung Koo Lee,Dong-Wan Seo,Sang Soo Lee,Do Hyun Park,Tae Jun Song,Guisuk Park,Yejong Park,Seung Jae Lee,Song Cheol Kim |
| ||Surgical Endoscopy. 2018; |
|[Pubmed] | [DOI]|
||Endoscopic Management of Infected Necrotizing Pancreatitis: an Evidence-Based Approach
| ||Lotte Boxhoorn,Paul Fockens,Marc G. Besselink,Marco J. Bruno,Jeanin E. van Hooft,Robert C. Verdonk,Rogier P. Voermans |
| ||Current Treatment Options in Gastroenterology. 2018; |
|[Pubmed] | [DOI]|
||Endoscopic Management of Pancreatic Fluid Collections
| ||Thiruvengadam Muniraj,Priya A. Jamidar,William H. Nealon,Harry R. Aslanian |
| ||Journal of Clinical Gastroenterology. 2017; 51(1): 19 |
|[Pubmed] | [DOI]|
||Efficacy and Safety of Lumen-Apposing Metal Stents in Management of Pancreatic Fluid Collections: Are They Better Than Plastic Stents? A Systematic Review and Meta-Analysis
| ||Tariq Hammad,Muhammad Ali Khan,Yaseen Alastal,Wade Lee,Ali Nawras,Mohammad Kashif Ismail,Michel Kahaleh |
| ||Digestive Diseases and Sciences. 2017; |
|[Pubmed] | [DOI]|
||Past, Present, and Future of Gastrointestinal Stents: New Endoscopic Ultrasonography-Guided Metal Stents and Future Developments
| ||Hee Seung Lee,Moon Jae Chung |
| ||Clinical Endoscopy. 2016; 49(2): 131 |
|[Pubmed] | [DOI]|