Gastric Outlet Obstruction Due to Gastric Adenocarcinoma Clinical Trial
Official title:
Comparison of Efficacy of Covered Versus Uncovered Self-expandable Metallic Stents for Treatment of Malignant Gastric Outlet Obstruction: a Prospective, Randomized Study
Malignant gastric outlet obstruction can result from gastric adenocarcinoma, leading to
intractable vomiting, nausea, and poor oral food intake. Although self-expandable metallic
stent (SEMS) insertion has excellent technical and clinical success rates for relieving
gastric outlet obstruction symptoms, the uncovered SEMS is susceptible to re-stenosis
because of tumor ingrowth through openings between the stent wire filaments. Therefore, the
most common reason for stent failure in uncovered stents is tumor ingrowth.
The covered SEMS has a membrane that prevents ingrowth through the mesh wall and
consequently shows lower rate of re-stenosis than uncovered SEMS. However, covered SEMS has
a higher risk of stent migration compared to uncovered SEMS. Recent prospective, randomized
study showed that there was no significant difference between uncovered and covered SEMS in
terms of stent patency rate as well as technical and clinical success rates.
Recently the investigators developed new covered SEMS for gastric outlet obstruction. This
new covered SEMS has features that may contribute to reducing migration rate: 1) partially
covered design; 2)less radial force in central portion of stent; 3) presence of lasso which
enable position of stent to be adjusted after deployment; 4)presence of protrusion in both
sides of stent. This prospective, randomized study aimed to compare the effectiveness and
side effects of newly developed covered SEMS with those of uncovered SEMS in patients with
malignant gastric outlet obstruction from gastric cancer.
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