A novel lumen-apposing stent for endoscopic ultrasonography

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Placement of a fully covered metal stent (AXIOS) for EUS-guided drainage of peripancreactic
fluid collections; a prospective European cohort study
D. Walter1, U. Will2, A. Sanchez-Yague3, D. Brenke4, J. Hampe5, J.M. H. Wollny6, J.M. Esteban
López-Jamar7, G. Jechart8, P. Vilmann9, J.B. Gornals10, H.S. Ullrich11, M. Fähndrich12, A. Herreros de
Tejada13, F. Junquera14, H. Schlieker15, F. Gonzalez-Huix16, P.D. Siersema1, F.P. Vleggaar1
1
Dept. Gastroenterology and Hepatology, UMC Utrecht, Utrecht, Netherlands
Dept. of Gastroenterology, Municipal Hospital, Gera, Germany
3
Endoscopy Unit, Hospital Costa del Sol, Marbella, Spain
4
Dept. of Internal Medicine II, Department of Gastroenterology, Hepatology and Diabetology, SKK Teaching
Hospital , Karlsruhe, Germany
5
Dept. of Internal Medicine I, UKSH, Kiel, Germany
6
Dept. of Internal Medicine and Gastroenterology, Medical Center Städte Region, Aachen, Germany
7
Dept. of Endoscopy, Hospital Clinico San Carlos, Madrid, Spain
8
Dept. of Gastroenterology, Klinikum Augsburg, Augsburg, Germany
9
Dept. of Surgery, University Hospital Herlev, Copenhagen, Denmark.
10
Dept. of Endoscopy, Hospital Universitari de Bellvitge-IDIBELL, Barcelona, Spain
11
Dept. of Internal Medicine I, Klinikum Asklepios Altona, Hamburg, Germany
12
Dept. of Interventional Endoscopy, Klinikum Dortmund, University Münster, Dortmund, Germany
13
Dept. of Gastroenterology, Puerta de Hierro University Hospital, Madrid, Spain
14
Dept. of Digestive Disease, Hospital Parc Tauli , Barcelona, Spain
15
Dept. of Gastroenterology, Klinikum Lippe-Detmold , Detmold, Germany
16
Endoscopy Unit, Clinica Girona, Girona, Spain
2
Endoscopic ultrasonography (EUS)-guided transmural drainage with placement of double-pigtail
plastic stents is an important treatment for symptomatic peripancreatic fluid collections (PFC). The
limitation of small-diameter plastic stents (7/10F) is the high risk of stent occlusion, especially in
PFCs containing necrotic debris. Stent occlusion may result in infection and delayed PFC resolution.
A novel large-diameter (10/15mm) fully-covered self- expanding metal stent, the AXIOS stent, has
been developed to overcome these limitations. We evaluated technical and clinical success, stent
migration and safety of EUS-guided PFC drainage using the AXIOS stent. From May 2011 until
November 2012 patients who underwent EUS-guided drainage of PFCs with the AXIOS stent in 16
European medical centers were prospectively enrolled in a web-based database. In total, 62 patients
(39 men, median age 54 (range 22 - 88) years) were included. PFCs were classified as walled-of
pancreatic necrosis (n=47) or pancreatic pseudocyst (n=15) and almost half of the PFCs were infected
(n=29; 47%). The median diameter of the PFC was 90 mm (range 40-230). A transgastric approach
was used in the 59 patients (94%) and in 3 patients (6%) a transduodenal drainage was performed.
Stent placement was technically successful in 61 patients (98%) while in 1 patient the entire stent was
deployed inside the PFC and was removed during a subsequent endoscopy. Resolution of the PFC was
achieved in 51 patients (82%) after a median of 29 days (range 1-136) days. In 5 patients (8%), the
PFC has not yet been resolved, 3 patients (5%) required surgery because of severe sepsis, 1 patient
(2%) died due to an unrelated cause before resolution and 2 patients (3%) were lost to follow up. Stent
removal was successfully performed in 43 patients (70%) after a median of 32 days (range 2-178), 13
stents (21%) are still in situ, 4 stents (6%) dislodged during endoscopic transmural necrosectomy and
2 stents (3%) migrated to the GI-tract without complications. Stent removal was rated as easy in 42
patients (98%), but in 1 patient hyperplastic tissue ingrowth made removal difficult. In total, 13 major
complications were reported in 12 patients (19%), including stent dislodgement (n=4), infection of the
PFC (n=4), stent migration (n=2), bleeding (n=1), retroperitoneal abscess (n=1) and abdominal pain
after stent removal (n=1). We concluded that placement and removal of the AXIOS stent is technically
feasible for drainage of PFCs with an acceptable complication rate. Clinical success seems promising
but further studies with longer follow-up and a direct comparison with plastic stents are needed.
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