Covered metal versus plastic stents for malignant common bile duct stenosis: a prospective, randomized, controlled trial.
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).


METHODS
Single-center, prospective, randomized, controlled trial.


METHODS
General hospital in Stockholm, Sweden, which has a catchment area of 0.6 million people.


METHODS
Non-referred, unresectable malignant common bile duct strictures.


METHODS
Endoscopic retrograde cholangiography with plastic stents or covered SEMS.


METHODS
Time to stent failure, requiring a new stent.


CONCLUSIONS
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.
Soderlund
Claes
C
Karolinska Institutet, Upper GI Surgery, Department of Surgery, South Hospital, SE 118-83 Stockholm, Sweden.
Linder
Stefan
S
D000368:Aged; D000369:Aged, 80 and over; D001650:Bile Duct Neoplasms / Q000150:complications / Q000473:pathology; D001653:Bile Ducts, Intrahepatic; D018281:Cholangiocarcinoma / Q000150:complications / Q000473:pathology; D003135:Common Bile Duct / Q000473:pathology*; D003251:Constriction, Pathologic; D016099:Endoscopy, Gastrointestinal; D005260:Female; D006801:Humans; D041781:Jaundice, Obstructive / Q000628:therapy*; D008297:Male; D008670:Metals; D008875:Middle Aged; D010166:Palliative Care; D010190:Pancreatic Neoplasms / Q000150:complications / Q000473:pathology; D010969:Plastics; D011446:Prospective Studies; D011474:Prosthesis Design; D015607:Stents
D008670:Metals; D010969:Plastics