Fully Covered Self-Expanding Metal Stents Are Safe and May Be More Durable in Distal Malignant Biliary Obstruction

Fully Covered Self-Expanding Metal Stents Are Safe and May Be More Durable in Distal Malignant Biliary Obstruction

Rajesh N. Keswani, MD, MS, reviewing Ghazi R, et al. Gastrointest Endosc 2023 May 15.

It is clear that metal stents are superior to plastic stents for palliation of distal malignant biliary obstruction (dMBO). Among self-expanding metal stents (SEMS), there are 3 choices: uncovered SEMS (UCSEMS), partially covered SEMS (PCSEMS), and fully covered SEMS (FCSEMS). UCSEMS have a higher risk of tissue/tumor ingrowth than FCSEMS but a lower risk of migration. Moreover, FCSEMS can be removed if stent occlusion occurs and replaced with a new stent (rather than needing to place a second coaxial stent).

In this study by Ghazi et al, the investigators retrospectively evaluated a large cohort of patients with clinical follow-up who underwent ERCP for dMBO (82.6% pancreatic adenocarcinoma), comparing the outcomes of FCSEMS (n=90) and UCSEMS (n=364). The median duration of follow-up was 9.6 months.

Clinical success, defined as a reduction in serum bilirubin of 33% by one week or 50% by two weeks, was similar between UCSEMS (89.3%) and FCSEMS (93.3%; P=.25). There was a higher percentage of adverse events in the UCSEMS group versus FCSEMS group overall (33.5% vs 21.1%; P=.02), though a large proportion of this was due to tissue ingrowth (26.9% vs 8.9%; P<.001) in the USCSEMS group. The authors found a higher proportion of stent migrations in the FCSEMS group (7.8% vs 1.1%, P<.001); however, there were no statistically significant differences in the rates of other adverse events, such as post-ERCP pancreatitis, cholecystitis, bleeding, perforation, and stent misdeployment, between both groups.

The UCSEMS group had a higher rate of unplanned reintervention (27.0% vs 11.1%; P=.002) and a shorter time to reintervention (4.4 months vs 7.6 months; P=.04), both of which were likely due to the higher rates of stent occlusion noted in the UCSEMS group.



Although this provocative study is retrospective in nature, it provides good evidence that FCSEMS are effective and may be more durable than UCSEMS. While it appears reasonable for endoscopists to use FCSEMS as first-line therapy for dMBO based on available data, a well-conducted prospective multicenter randomized controlled trial is needed to inform clinical guidelines more broadly.


Note to readers: At the time we reviewed this paper, its publisher noted that it was not in final form and that subsequent changes might be made.


Ghazi R, AbiMansour JP, Mahmoud T, et al. Uncovered versus fully-covered self-expandable metal stents for the management of distal malignant biliary obstruction. Gastrointest Endosc 2023 May 15. (Epub ahead of print) (https://doi.org/10.1016/j.gie.2023.05.047)

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