Covered Versus Uncovered Self-expandable Metallic Stents for Malignant Gastric Outlet Obstruction
Recruitment status was Recruiting
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.
Gastric Outlet Obstruction Due to Gastric Adenocarcinoma
Device: Covered stent (Bona stent pyloric/duodenal covered) insertion
Device: Uncovered stent (Bona stent, pyloric/duodenal) insertion
|Official Title:||Comparison of Efficacy of Covered Versus Uncovered Self-expandable Metallic Stents for Treatment of Malignant Gastric Outlet Obstruction: a Prospective, Randomized Study|
- Stent patency at 8 weeks after stent insertion
|Study Start Date:||July 2012|
|Active Comparator: Covered stent (Bona stent, pyloric/duodenal covered)||Device: Covered stent (Bona stent pyloric/duodenal covered) insertion|
|Active Comparator: Uncovered stent (Bona stent, pyloric/duodenal)||Device: Uncovered stent (Bona stent, pyloric/duodenal) insertion|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01646476
|Contact: Byung-Hoon Minfirstname.lastname@example.org|
|Korea, Republic of|
|Samsung Medical Center||Recruiting|
|Seoul, Korea, Republic of|
|Contact: Byung-Hoon Min 82-2-3410-3409 email@example.com|