Nitinol versus steel partially covered self-expandable metal stent for malignant distal biliary obstruction: a randomized trial

Claes Soderlund; Stefan Linder; Per E. Bergenzaun; Tomas Grape; Hans-Olof Hakansson; Anders Kilander; Gert Lindell; Martin Ljungman; Bo Ohlin; Jorgen Nielsen; Claes Rudberg; Per-Ove Stotzer; Erik Svartholm; Ervin Toth; Farshad Frozanpor

doi:10.1055/s-0034-1377936

Endoscopy, Inhaltsverzeichnis

Endoscopy 2014; 46(11): 941-948
DOI: 10.1055/s-0034-1377936

Original article

Nitinol versus steel partially covered self-expandable metal stent for malignant distal biliary obstruction: a randomized trial

Claes Soderlund

¹Department of Surgery, South Hospital, Stockholm, Sweden

,

Stefan Linder

²Department of Surgical Sciences, Uppsala University, Uppsala, Sweden

,

Per E. Bergenzaun

³Departments of Surgery and Gastroenterology, Skane University Hospital, Lund, Sweden

,

Tomas Grape

⁴Department of Surgery, Kristianstad Hospital, Kristianstad, Sweden

,

Hans-Olof Hakansson

⁵Department of Surgery, Kalmar Hospital, Kalmar, Sweden,

,

Anders Kilander

⁶Department of Gastroenterology, Sahlgrenska University Hospital, Gothenburg, Sweden

,

Gert Lindell

³Departments of Surgery and Gastroenterology, Skane University Hospital, Lund, Sweden

,

Martin Ljungman

⁷Department of Surgery, Central Hospital, Vasteras, Sweden

,

Bo Ohlin

⁸Department of Surgery, Blekinge Hospital, Karlskrona, Sweden

,

Jorgen Nielsen

¹⁰Department of Gastroenterology, Skane University Hospital, Malmoe, Sweden

,

Claes Rudberg

⁷Department of Surgery, Central Hospital, Vasteras, Sweden

,

Per-Ove Stotzer

⁶Department of Gastroenterology, Sahlgrenska University Hospital, Gothenburg, Sweden

,

Erik Svartholm

⁹Department of Surgery, Ryhov Hospital, Jonkoping, Sweden

,

Ervin Toth

¹⁰Department of Gastroenterology, Skane University Hospital, Malmoe, Sweden

,

Farshad Frozanpor

¹¹Department of Surgery, Danderyd Hospital, Stockholm, Sweden

› Institutsangaben

Abstract

Background and study aims: Covered nitinol alloy self-expandable metal stents (SEMSs) have been developed to overcome the shortcomings of steel SEMS in patients with malignant biliary obstruction. In a randomized, multicenter trial, we compared stent patency, patient survival, and adverse events in patients with partly covered stents made from steel or nitinol.

Patients and methods: A total of 400 patients with unresectable distal malignant biliary obstruction were randomized at endoscopic retrograde cholangiopancreatography (ERCP) to insertion of a steel or nitinol partially covered SEMS, with 200 patients in each group. The primary outcome was confirmed stent failure during 300 days of follow-up.

Results: At 300 days, the proportion of patients with patent stents was 77 % in the steel group, compared with 89 % in the nitinol group (P = 0.01). Confirmed stent failure occurred more often in the steel SEMS group compared with the nitinol SEMS group, in 30 versus 14 patients (P = 0.02). Stent migration occurred in 13 patients in the steel group and in 3 patients in the nitinol group (P = 0.01). Median patient survival (secondary outcome) was 137 days and 120 days in the steel SEMS and nitinol SEMS groups, respectively (P = 0.59).

Conclusions: The nitinol SEMS showed longer patency time, and the nitinol group had fewer patients with stent failure, compared with the steel SEMS group. We could not detect any differences between the two groups regarding survival time, and regarding adverse event rate.

Clinical trial registration : NCT 00980889

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Referenzen

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