Original article Clinical endoscopy| Volume 84, ISSUE 3, P450-457.e2, September 2016

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

Published:March 09, 2016DOI:

      Background and Aims

      Initial reports suggest that fully covered self-expandable metal stents (FCSEMSs) may be better suited for drainage of dense pancreatic fluid collections (PFCs), such as walled-off pancreatic necrosis. The primary aim was to analyze the effectiveness and safety of FCSEMSs for drainage of different types of PFCs in a large cohort. The secondary aim was to investigate which type of FCSEMS is superior.


      This was a retrospective, noncomparative review of a nationwide database involving all hospitals in Spain performing EUS-guided PFC drainage. From April 2008 to August 2013, all patients undergoing PFC drainage with an FCSEMS were included in a database. The main outcome measurements were technical success, short-term (2 weeks) and long-term (6 months) effectiveness, adverse events, and need for surgery.


      The study included 211 patients (pseudocyst/walled-off pancreatic necrosis, 53%/47%). The FCSEMSs used were straight biliary (66%) or lumen-apposing (34%). Technical success was achieved in 97% of patients (95% confidence interval [CI], 93%-99%). Short-term- and long-term clinical success was obtained in 94% (95% CI, 89%-97%) and 85% (95% CI, 79%-89%) of patients, respectively. Adverse events occurred in 21% of patients (95% CI, 16%-27%): infection (11%), bleeding (7%), and stent migration and/or perforation (3%). By multivariate analysis, patient age (>58 years) and previous failed drainage were the most important factors associated with negative outcome.


      An FCSEMS is effective and safe for PFC drainage. Older patients with a history of unsuccessful drainage are more likely to fail EUS-guided drainage. The type of FCSEMS does not seem to influence patient outcome.


      AE (adverse event), CI (confidence interval), F (French), FCSEMS (fully covered self-expandable metal stent), LAMS (lumen-apposing metal stent), LTCS (long-term clinical success), MRI (magnetic resonance imaging), OR (odds ratio), PFC (pancreatic fluid collection), RSS (required salvage surgery), SBFCSEMS (straight biliary fully covered self-expandable metal stent), SD (standard deviation), STCS (short-term clinical success), TS (technical success), WOPN (walled-off pancreatic necrosis)
      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'


      Subscribe to Gastrointestinal Endoscopy
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect


        • Bradley III, E.L.
        A clinically based classification system for acute pancreatitis: summary of the International Symposium on Acute Pancreatitis, Atlanta, GA, September 11 through 13, 1992.
        Arch Surg. 1993; 128: 586-590
        • Banks P.A.
        • Bollen T.L.
        • Dervenis C.
        • et al.
        Classification of acute pancreatitis-2012: revision of the Atlanta classification and definitions by international consensus.
        Gut. 2013; 62: 102-111
        • Bailley J.
        Pancreatic pseudocysts.
        Gastrointest Endosc. 2004; 59: 873-879
        • Yasuda I.
        • Nakashima M.
        • Iwai T.
        • et al.
        Japanese multicenter experience of endoscopic necrosectomy for infected walled-off pancreatic necrosis: the JENIPaN study.
        Endoscopy. 2013; 45: 627-634
        • Holt B.A.
        • Varadarajulu S.
        The endoscopic management of pancreatic pseudocysts (with videos).
        Gastrointest Endosc. 2015; 81: 804-812
        • Tandan M.
        • Reddy D.N.
        Endotherapy in chronic pancreatitis.
        World J Gastroenterol. 2013; 19: 6156-6164
        • Jacobson B.C.
        • Baron T.H.
        • Adler D.G.
        • et al.
        ASGE guideline: the role of endoscopy in the diagnosis and the management of cystic lesions and inflammatory fluid collections of the pancreas.
        Gastrointest Endosc. 2005; 61: 363-370
        • Varadarajulu S.
        • Bang J.Y.
        • Sutton B.S.
        • et al.
        Equal efficacy of endoscopic and surgical cystogastrostomy for pancreatic pseudocyst drainage in a randomized trial.
        Gastroenterology. 2013; 145: 583-590
        • Kawakami H.
        • Itoi T.
        • Sakamoto N.
        Endoscopic ultrasound-guided transluminal drainage for peripancreatic fluid collections: where are we now?.
        Gut Liver. 2014; 8: 341-355
        • Yusuf T.E.
        • Baron T.H.
        Endoscopic transmural drainage of pancreatic pseudocysts: results of a national and an international survey of ASGE members.
        Gastrointest Endosc. 2006; 63: 223-227
        • Kwon Y.M.
        • Gerdes H.
        • Schattner M.A.
        • et al.
        Management of peripancreatic fluid collections following partial pancreatectomy: a comparison of percutaneous versus EUS-guided drainage.
        Surg Endosc. 2013; 27: 2422-2427
      1. Keane MG, Sze SF, Cieplik N, et al. Endoscopic versus percutaneous drainage of symptomatic pancreatic fluid collections: a 14-year experience from a tertiary hepatobiliary centre. Surg Endosc. Epub 2015 Dec 16.

        • Bang D.Y.
        • Varadarajulu S.
        Metal versus plastic stent for transmural drainage of pancreatic fluid collections.
        Clin Endosc. 2013; 46: 500-502
        • Baron T.H.
        • Thaggard W.G.
        • Morgan D.E.
        • et al.
        Endoscopic therapy for organized pancreatic necrosis.
        Gastroenterology. 1996; 111: 755-764
        • Shah R.
        • Shah J.N.
        • 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
        • Varadarajulu S.
        • Bang J.Y.
        • Phadnis M.A.
        • 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
        • Bang J.Y.
        • Wilcox C.M.
        • Trevino J.M.
        • et al.
        Relationship between stent characteristics and treatment outcomes in endoscopic transmural drainage of pancreatic pseudocysts [abstract].
        Gastrointest Endosc. 2013; 77: AB382
        • Sadik R.
        • Kalaitzakis E.
        • Thune A.
        • et al.
        EUS-guided drainage is more successful in pancreatic pseudocysts compared with abscesses.
        World J Gastroenterol. 2011; 17: 499-505
        • Gluck M.
        • Ross A.
        • Irasi S.
        • et al.
        Endoscopic and percutaneous drainage of symptomatic walled-off pancreatic necrosis reduces hospital stay and radiographic resources.
        Clin Gastroenterol Hepatol. 2010; 8: 1083-1088
        • Bang J.Y.
        • Hasan M.
        • Hawes R.H.
        • et al.
        Factors impacting treatment outcomes in the endoscopic management of walled-off pancreatic necrosis.
        J Gastroenterol Hepatol. 2013; 28: 1725-1732
        • Seewald S.
        • Ang T.L.
        • Richter H.
        • et al.
        Long-term results after endoscopic drainage and necrosectomy of symptomatic pancreatic fluid collections.
        Dig Endosc. 2012; 24: 36-41
        • Itoi T.
        • Binmoeller K.F.
        • 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
        • Belle S.
        • Collet P.
        • Post S.
        • et al.
        Temporary cystogastrostomy with self-expanding metallic stents for pancreatic necrosis.
        Endoscopy. 2010; 42: 493-495
        • Berzosa M.
        • Maheshwari S.
        • Patel K.K.
        • et al.
        Single-step endoscopic ultrasonography-guided drainage of peripancreatic fluid collections with a single self-expandable metal stent and standard linear echoendoscope.
        Endoscopy. 2012; 44: 543-547
        • 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
        • Penn D.E.
        • Draganov P.V.
        • Wagh M.S.
        • 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
        • Weilert F.
        • Binmoeller K.F.
        • Shah J.N.
        • et al.
        Endoscopic ultrasound-guided drainage of pancreatic fluid collections with indeterminate adherence using temporary covered metal stents.
        Endoscopy. 2012; 44: 780-783
        • Talreja S.P.
        • Shami V.M.
        • 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
        • Tarantino I.
        • Barresi L.
        • Fazio V.
        • et al.
        EUS-guided self-expandable metal stent placement in 1 step: a new method to treat pancreatic abscess.
        Gastrointest Endosc. 2009; 69: 1401-1403
        • Tarantino I.
        • Di Pisa M.
        • Barresi L.
        • et al.
        Covered self expandable metallic stent with flared plastic one inside for pancreatic pseudocyst avoiding stent dislodgement.
        World J Gastrointest Endosc. 2012; 4: 148-150
        • Tarantino I.
        • Traina M.
        • Barresi L.
        • et al.
        EUS-guided drainage for pancreatic and peripancreatic fluid collections: treatment of infected pancreatic pseudocysts using a novel, dedicated covered self-expandable metal stent (CSEMS) with an effective antimigration system.
        Endoscopy. 2012; 44: E147-E148
        • Barresi L.
        • Tarantino I.
        • Curcio G.
        • et al.
        Buried stent: new complication of pseudocyst drainage with self-expandable metallic stent.
        Dig Endosc. 2012; 44: 543-547
        • Gornals J.B.
        • Loras C.
        • Mast R.
        • et al.
        Endoscopic ultrasound-guided transesophageal drainage of a mediastinal pancreatic pseudocyst using a novel lumen-apposing metal stent.
        Endoscopy. 2012; 44: E211-E212
        • Gornals J.B.
        • De la Serna-Higuera C.
        • Sánchez-Yague A.
        • et al.
        Endosonography-guided drainage of pancreatic fluid collections with a novel lumen-apposing stent.
        Surg Endosc. 2013; 27: 1428-1434
        • Yamamoto N.
        • Isayama H.
        • Kawakami H.
        • et al.
        Preliminary report on a new, fully covered, metal stent designed for the treatment of pancreatic fluid collections.
        Gastrointest Endosc. 2013; 77: 809-814
        • Téllez-Ávila F.I.
        • Villalobos-Garita A.
        • Ramírez-Luna M.Á.
        Use of a novel covered self-expandable metal stent with an anti-migration system for endoscopic ultrasound-guided drainage of a pseudocyst.
        World J Gastrointest Endosc. 2013; 5: 297-299
        • Saxena P.
        • Kumbhari V.
        • Khashab M.A.
        EUS-guided drainage of a giant hemorrhagic pseudocyst by a through-the-scope esophageal metal stent.
        Gastrointest Endosc. 2014; 79: 202-203
        • Sharaiha R.Z.
        • DeFilippis E.M.
        • Kedia P.
        • et al.
        Metal versus plastic for pancreatic pseudocyst drainage: clinical outcomes and success.
        Gastrointest Endosc. 2015; 82: 822-827
        • Rinniella 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
        • Walter D.
        • Will U.
        • Sanchez-Yague A.
        • et al.
        A novel lumen-apposing metal stent for endoscopic ultrasound-guided drainage of pancreatic fluid collections: a prospective cohort study.
        Endoscopy. 2015; 47: 63-67
        • Huggett M.T.
        • Oppong K.W.
        • Pereira S.P.
        • et al.
        Endoscopic drainage of walled-off pancreatic necrosis using a novel self-expanding metal stent.
        Endoscopy. 2015; 47: 929-932
        • Oh D.
        • Park D.H.
        • Cho M.K.
        • et al.
        Feasibility and safety of a fully covered self-expandable metal stent with antimigration properties for EUS-guided pancreatic duct drainage: early and midterm outcomes (with video).
        Gastrointest Endosc. 2016; 83: 366-373.e2
        • Dhaka N.
        • Samanta J.
        • Kochhar S.
        • et al.
        Pancreatic fluid collections: what is the ideal imaging technique?.
        World J Gastroenterol. 2015; 21: 13403-13410