Newly designed, fully covered metal stents for endoscopic ultrasound (EUS)-guided transmural drainage of peripancreatic fluid collections: a prospective randomized study

Background and study aims: Peripancreatic fluid collections (PFCs) have been adequately drained using multiple plastic stents placed in a single-step endoscopic ultrasound (EUS) procedure. Recent reports have presented the usefulness of metal stents for this procedure; however, there has been no prospective comparative study on their effectiveness and safety. We conducted a prospective randomized study to compare multiple plastic stents with fully covered, self-expanding metal stents (FCSEMSs) for the drainage of PFCs.

Patients and methods: Between January 2012 and May 2013, patients with PFCs demonstrated by various modalities were enrolled in our study. Patients were randomly assigned to receive either a FCSEMS or plastic stents for EUS-guided PFC drainage. The procedure time, technical success rate, and adverse event rates of the PFCs were evaluated.

Results: 50 patients (41 men) were included and randomly assigned to either the FCSEMS group (n = 25) or the plastic stent group (n = 25). The median procedure time with FCSEMS was significantly shorter than with plastic stents (15.0 min vs. 29.5 min, P < 0.01). The technical success rate was 100 % for both groups. The clinical success rate was 20 out of 23 for FCSEMS and 20 out of 22 for plastic stents (P = 0.97). No adverse events occurred in the FCSEMS group, while adverse events occurred in two patients in the plastic stent group (P = 0.16). One recurrence was observed during follow-up in the FCSEMS group and none in the plastic stent group (P = 0.15).

Conclusions: EUS-guided PFC drainage with FCSEMSs is comparable to such drainage with plastic stents in terms of technical feasibility, efficacy, and safety; however, the use of FCSEMSs may also simplify and shorten the procedure.

Clinical trial registration: KCT0000766 (https://cris.nih.go.kr)

• References

• 1 Baron TH. Endoscopic drainage of pancreatic fluid collections and pancreatic necrosis. Gastrointest Endosc Clin N Am 2003; 13: 743-764
• 2 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 2006; 63: 635-643
• 3 Kozarek RA, Brayko CM, Harlan J et al. Endoscopic drainage of pancreatic pseudocysts. Gastrointest Endosc 1985; 31: 322-327
• 4 Sahel J, Bastid C, Pellat B et al. Endoscopic cystoduodenostomy of cysts of chronic calcifying pancreatitis: a report of 20 cases. Pancreas 1987; 2: 447-453
• 5 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
• 6 Baron TH, Thaggard WG, Morgan DE et al. Endoscopic therapy for organized pancreatic necrosis. Gastroenterology 1996; 111: 755-764
• 7 Arvanitakis M, Delhaye M, Bali MA et al. Pancreatic-fluid collections: a randomized controlled trial regarding stent removal after endoscopic transmural drainage. Gastrointest Endosc 2007; 65: 609-619
• 8 Park DH, Lee SS, Moon SH et al. Endoscopic ultrasound-guided versus conventional transmural drainage for pancreatic pseudocysts: a prospective randomized trial. Endoskopie Heute 2009; 22: 243-250
• 9 Giovannini M, Pesenti C, Rolland AL et al. Endoscopic ultrasound-guided drainage of pancreatic pseudocysts or pancreatic abscesses using a therapeutic echo endoscope. Endoscopy 2001; 33: 473-477
• 10 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 2005; 37: 977-983
• 11 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
• 12 Banks PA, Bollen TL, Dervenis C et al. Classification of acute pancreatitis – 2012: revision of the Atlanta classification and definition by international consensus. Gut 2013; 62: 102-111
• 13 Lopes CV, Pesenti C, Bories E et al. Endoscopic-ultrasound-guided endoscopic transmural drainage of pancreatic pseudocysts and abscesses. Scand J Gastroenterol 2007; 42: 524-529
• 14 Tarantino I, Traina M, Barresi L et al. Transgastric plus transduodenal necrosectomy with temporary metal stents placement for treatment of large pancreatic necrosis. Pancreas 2010; 39: 269-270
• 15 Belle S, Collet P, Post S et al. Temporary cystogastrostomy with self-expanding metallic stents for pancreatic necrosis. Endoscopy 2010; 42: 493-495
• 16 Kahaleh M, Shami VM, Conaway MR et al. Endoscopic ultrasound drainage of pancreatic pseudocyst: a prospective comparison with conventional endoscopic drainage. Endoscopy 2006; 38: 355-359
• 17 Gerolami R, Giovannini M, Laugier R. Endoscopic drainage of pancreatic pseudocysts guided by endosonography. Endoscopy 1997; 29: 106-108
• 18 Berzosa M, Maheshwari S, Patel KK 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
• 19 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
• 20 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