Covered metallic stents effective for relieving benign biliary stricture

Last Updated: 2016-03-22

By Will Boggs MD

NEW YORK (Reuters Health) - Covered, self-expandable metallic stents (cSEMS) appear to be as effective as plastic stents for relieving benign biliary stricture, according to results of a noninferiority study.

"Fully covered, self-expandable metallic stents allow us to treat many benign bile duct strictures without the need for serial dilation and upsizing of plastic stents as we have been doing for the past several decades," Dr. Gregory A. Cote from Medical University of South Carolina, Charleston, told Reuters Health by email. "Still, physicians must be comfortable with deploying and removing cSEMS and in precisely defining the bile duct stricture using cholangiography before commencing with therapy."

Plastic stent therapy often requires multiple treatment sessions to obtain the high reported success rates. Several small clinical trials have shown that deployment of cSEMS can be beneficial in patients with benign biliary strictures.

Dr. Cote and colleagues at eight regional referral centers for endoscopic retrograde cholangiopancreatography (ERCP) and liver transplantation in the U.S. and UK compared cSEMS with multiple plastic stents in a noninferiority, open-label, randomized study of 112 patients undergoing first-line endoscopic treatment of benign bile duct strictures.

The stricture resolution rate was 92.6% (50/54) for cSEMS patients, compared with 85.4% (41/48) for multiple plastic stents (p<0.001), thus satisfying the predetermined noninferiority criteria according to the March 22/29 JAMA report.

Patients who received a cSEMS achieved stricture resolution significantly faster (median, 181 days) than did patients who received multiple plastic stents (median, 225 days, p=0.006).

cSEMS patients also achieved stricture resolution after significantly fewer ERCPs (mean, 2.14 versus 3.24 for multiple plastic stent patients, p<0.001).

Recurrent biliary stricture was more common after cSEMS (7/50, 14%) than after multiple plastic stents (2/41, 4.9%), but the difference was not statistically significant.

Neither group required stent removal or experienced stent-induced strictures that required treatment, but cSEMS migration (16 cases in 14 patients) was more common than was plastic stent migration (10 cases in 9 patients).

Dr. Cote favors cSEMS over multiple plastic stents "when the bile duct is large enough to accommodate a cSEMS; this is basically a 6-mm or larger duct. This is almost always the case for benign strictures after cholecystectomy and in the setting of chronic pancreatitis, and often the case for patients who have undergone a biliary anastomosis (usually after a liver transplant)."

"In addition," he said, "most of us will prefer a cSEMS when the stent is long enough to cross the stricture and cross the major papilla; this permits easier removal during a follow-up procedure."

"I predict that cSEMS manufacturers will innovate as these stents become increasingly preferred for first-line use," Dr. Cote concluded. "This a nice example of a more expensive technology that actually lowers overall health care costs from the societal perspective, since patients can have their stricture addressed with fewer interventions."

The National Institute of Diabetes and Digestive and Kidney Diseases and the American Society for Gastrointestinal Endoscopy supported this research.

SOURCE: http://bit.ly/1MkSsD8

JAMA 2016.