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Covered metallic stents with an anti-migration design vs. uncovered stents for the palliation of malignant gastric outlet obstruction: a multicenter, randomized trial.

Lee H, Min BH, Lee JH, Shin CM, Kim Y, Chung H, Lee SH - Am. J. Gastroenterol. (2015)

Bottom Line: Overall stent patency was significantly longer in the WCS group than in the UCS group.No stent-associated significant adverse events occurred in either the WCS or UCS groups.WCS group showed comparable migration rate and significantly more durable long-term stent patency compared with UCS group for the palliation of GOO in patients with inoperable gastric cancer.

View Article: PubMed Central - PubMed

Affiliation: Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.

ABSTRACT

Objectives: Previous studies reported comparable stent patency between covered self-expandable metallic stents (SEMS) and uncovered SEMS (UCS) for palliation of malignant gastric outlet obstruction (GOO). The aim of this study was to evaluate the efficacy and safety of the newly developed WAVE-covered SEMS (WCS), which has an anti-migration design, compared with UCS in gastric cancer patients with symptomatic GOO.

Methods: A total of 102 inoperable gastric cancer patients with symptomatic GOO were prospectively enrolled from five referral centers and randomized to undergo UCS or WCS placement. Stent patency and recurrence of obstructive symptoms were assessed at 8 weeks and 16 weeks after stent placement.

Results: At the 8-week follow-up, both stent patency rates (72.5% vs. 62.7%) and re-intervention rates (19.6% vs. 19.6%) were comparable between the WCS and the UCS groups. Both stent stenosis (2.4% vs. 8.1%) and migration rates (9.5% vs. 5.4%) were comparable between WCS and UCS groups. At the 16-week follow-up, however, the WCS group had a significantly higher stent patency rate than the UCS group (68.6% vs. 41.2%). Re-intervention rates in the WCS and UCS groups were 23.5% and 39.2%, respectively. Compared with the UCS group, the WCS group had a significantly lower stent restenosis rate (7.1% vs. 37.8%) and a comparable migration rate (9.5% vs. 5.4%). Overall stent patency was significantly longer in the WCS group than in the UCS group. No stent-associated significant adverse events occurred in either the WCS or UCS groups. In the multivariate analysis, WCS placement and chemotherapy were identified as independent predictors of 16-week stent patency.

Conclusions: WCS group showed comparable migration rate and significantly more durable long-term stent patency compared with UCS group for the palliation of GOO in patients with inoperable gastric cancer.

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Related in: MedlinePlus

WAVE-covered self-expandable metallic stent with an anti-migration design (a), uncovered self-expandable metallic stent (b).
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fig1: WAVE-covered self-expandable metallic stent with an anti-migration design (a), uncovered self-expandable metallic stent (b).

Mentions: The newly developed WCS is a partially covered stent made of a nitinol hook and a cross wire structure with a diameter of 20 mm (Figure 1). WCS has several features that prevent migration. The stent body is indented in the central portion and thus has a bumpy and wavy external appearance, providing mechanical resistance to migration. The central part of the stent was designed to have reduced radial force compared with its proximal and distal parts (244 gf for the central part and 284 gf for the proximal and distal parts). Reduction of the radial force in the central part of the stent may help to prevent migration by allowing fixation at the stricture site. Platinum radiopaque markers were sutured in place in order to identify the central and bumpy portion of the stent, aiding in accurate placement. The WCS is completely covered with a silicone membrane in the middle; both the proximal and distal ends are uncovered and flared. In addition, this stent has a lasso at the proximal end to facilitate repositioning after deployment. The stents are available in 6, 8, 10, 12, 14, and 16 cm lengths with diameters of 18/24 mm (body/flare) at full expansion.


Covered metallic stents with an anti-migration design vs. uncovered stents for the palliation of malignant gastric outlet obstruction: a multicenter, randomized trial.

Lee H, Min BH, Lee JH, Shin CM, Kim Y, Chung H, Lee SH - Am. J. Gastroenterol. (2015)

WAVE-covered self-expandable metallic stent with an anti-migration design (a), uncovered self-expandable metallic stent (b).
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4697131&req=5

fig1: WAVE-covered self-expandable metallic stent with an anti-migration design (a), uncovered self-expandable metallic stent (b).
Mentions: The newly developed WCS is a partially covered stent made of a nitinol hook and a cross wire structure with a diameter of 20 mm (Figure 1). WCS has several features that prevent migration. The stent body is indented in the central portion and thus has a bumpy and wavy external appearance, providing mechanical resistance to migration. The central part of the stent was designed to have reduced radial force compared with its proximal and distal parts (244 gf for the central part and 284 gf for the proximal and distal parts). Reduction of the radial force in the central part of the stent may help to prevent migration by allowing fixation at the stricture site. Platinum radiopaque markers were sutured in place in order to identify the central and bumpy portion of the stent, aiding in accurate placement. The WCS is completely covered with a silicone membrane in the middle; both the proximal and distal ends are uncovered and flared. In addition, this stent has a lasso at the proximal end to facilitate repositioning after deployment. The stents are available in 6, 8, 10, 12, 14, and 16 cm lengths with diameters of 18/24 mm (body/flare) at full expansion.

Bottom Line: Overall stent patency was significantly longer in the WCS group than in the UCS group.No stent-associated significant adverse events occurred in either the WCS or UCS groups.WCS group showed comparable migration rate and significantly more durable long-term stent patency compared with UCS group for the palliation of GOO in patients with inoperable gastric cancer.

View Article: PubMed Central - PubMed

Affiliation: Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.

ABSTRACT

Objectives: Previous studies reported comparable stent patency between covered self-expandable metallic stents (SEMS) and uncovered SEMS (UCS) for palliation of malignant gastric outlet obstruction (GOO). The aim of this study was to evaluate the efficacy and safety of the newly developed WAVE-covered SEMS (WCS), which has an anti-migration design, compared with UCS in gastric cancer patients with symptomatic GOO.

Methods: A total of 102 inoperable gastric cancer patients with symptomatic GOO were prospectively enrolled from five referral centers and randomized to undergo UCS or WCS placement. Stent patency and recurrence of obstructive symptoms were assessed at 8 weeks and 16 weeks after stent placement.

Results: At the 8-week follow-up, both stent patency rates (72.5% vs. 62.7%) and re-intervention rates (19.6% vs. 19.6%) were comparable between the WCS and the UCS groups. Both stent stenosis (2.4% vs. 8.1%) and migration rates (9.5% vs. 5.4%) were comparable between WCS and UCS groups. At the 16-week follow-up, however, the WCS group had a significantly higher stent patency rate than the UCS group (68.6% vs. 41.2%). Re-intervention rates in the WCS and UCS groups were 23.5% and 39.2%, respectively. Compared with the UCS group, the WCS group had a significantly lower stent restenosis rate (7.1% vs. 37.8%) and a comparable migration rate (9.5% vs. 5.4%). Overall stent patency was significantly longer in the WCS group than in the UCS group. No stent-associated significant adverse events occurred in either the WCS or UCS groups. In the multivariate analysis, WCS placement and chemotherapy were identified as independent predictors of 16-week stent patency.

Conclusions: WCS group showed comparable migration rate and significantly more durable long-term stent patency compared with UCS group for the palliation of GOO in patients with inoperable gastric cancer.

Show MeSH
Related in: MedlinePlus