Medline ® Abstract for Reference 56
Covered metal versus plastic stents for malignant common bile duct stenosis: a prospective, randomized, controlled trial.
Soderlund C, Linder S
Gastrointest Endosc. 2006;63(7):986.
BACKGROUND: Most patients with malignant common bile duct strictures are suited only for palliation of jaundice by placement of a polyethylene (PE) stent using an endoscopic retrograde cholangiographic technique. Occlusion of these stents occurs after 3 to 4 months, whereas uncovered self-expanding metal stents (SEMS) remain open twice as long. The initial higher cost of the latter might be balanced by a decreased need for repeat intervention.
OBJECTIVE: To compare the patency of 10F PE stents and covered 30F steel SEMS (Wallstent; Boston Scientific Nordic AB, Helsingborg, Sweden).
DESIGN: Single-center, prospective, randomized, controlled trial.
SETTING: General hospital in Stockholm, Sweden, which has a catchment area of 0.6 million people.
PATIENTS: Non-referred, unresectable malignant common bile duct strictures.
INTERVENTIONS: Endoscopic retrograde cholangiography with plastic stents or covered SEMS.
MAIN OUTCOME MEASUREMENTS: Time to stent failure, requiring a new stent.
LIMITATIONS: Similar setting and patients, and costs in Scandinavia.
RESULTS: Fifty-one and 49 patients were allocated to the PE stent and SEMS groups, respectively. Fifty-six patients died without stent failure within 10 months (median, 2.6 months). Twenty-two PE stent and 9 SEMS patients (P = .009) developed failure after a median of 1.1 and 3.5 months, respectively (P = .007). Median patency times were 1.8 and 3.6 months in the PE and SEMS groups, respectively (P = .002). Median survival was 4.5 months; in 35 patients with distant metastases, the median survival was 2.5 months (P = .002)(PE group, 1.9 months).
CONCLUSIONS: The more-effective SEMS are recommended in unresectable patients with malignant common bile duct strictures, who survive a median of 4.5 months. Less costly plastic stents are preferable in the one third of patients who have distant metastases. In our study, the cost was equal.
Karolinska Institutet, Upper GI Surgery, Department of Surgery, South Hospital, SE 118-83 Stockholm, Sweden.