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SEMS placement found to be cost effective for bile duct obstruction

In a new clinical trial, researchers in The Netherlands found that the use of self-expandable metal stents are cost effective and have a longer functional time compared with plastic stents for patients with bile duct obstruction, according to data published in Gastroenterology.

“Studies have shown that [self-expandable metal stents] are superior to plastic stents in terms of recurrent biliary obstruction, number of re-interventions and functional stent time,” the researchers wrote. “Nonetheless, [self-expandable metal stent] placement is not accepted universally as standard treatment. The high cost of [self-expandable metal stents] and the uncertainty that these high costs might not be offset by a reduction in costs for re-interventions are the main reasons for reluctance, especially in patients with a short predicted survival time.”

To compare the use and cost effectiveness of plastic stents to self-expandable metal stents (SEMS), researchers, including Daisy Walter, MD, department of gastroenterology and hepatology, University Medical Center Utrecht, The Netherlands, randomly assigned 219 patients from 18 hospitals in The Netherlands to receive placement of a plastic stent (n = 73), uncovered SEMS (uSEMS, n = 75), or partially covered SEMS (pcSEMS, n = 71) during endoscopic retrograde cholangiopancreatography. The patients were followed up to 1 year.

Overall, stent placement was successful in 79% of patients (n = 174). Stent placement was unsuccessful in 26% of patients who underwent primary stent placement (44/171) and 2% of patients with a first episode of stent dysfunction (1/48), according to the research.

The mean functional stent times were 172 days for the plastic stents, 288 days for uSEMS and 299 days for pcSEMS (P < .005 for metal vs. plastic).

The initial placement of plastic stents cost $1,106 (1,042 euros), which was less than placement of SEMS ($2,094 or 1,973 euros; P = .001). The total cost per patient at the end of the follow-up period was $7,770 for the plastic stents (7,320 euros) and $7,356 for the SEMS (6,932 euros; P = .61).

“The total cost per patient at the end of the follow-up period did not differ significantly between plastic stents and SEMS,” the researchers wrote.

Also, for patients with a survival time of 3 months or less, or with metastatic disease, the total cost per patient was not different between plastic stents and SEMS. In addition, no differences in costs were seen between pcSEMS and uSEMS.

Five patients each in the plastic stent and uSEMS groups and three in the pcSEMS group experienced short-term serious adverse events. A total of 10 long-term serious adverse events occurred (P = .99) Cholecystitis occurred in one patient with a plastic stent and one with pcSEMS; pancreatitis in one patient with a plastic stent; and gastric outlet obstruction requiring stent replacement or surgery in 9 patients, which was the most common long-term complication.

The researchers concluded: “Although placement of SEMS, uncovered or partially covered, for palliation of extrahepatic bile duct obstruction initially is more expensive than placement of plastic stents, SEMS have longer functional time. The total costs after 1 year do not differ significantly with stent type.” – by Melinda Stevens

Disclosures: Walter reports no relevant financial disclosures. Please see the full study for a list of all other authors’ relevant financial disclosures.