Covered Versus Uncovered Self-expandable Metallic Stents for Malignant Gastric Outlet Obstruction

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2012 by Samsung Medical Center
Sponsor:
Information provided by (Responsible Party):
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01646476
First received: July 9, 2012
Last updated: August 5, 2012
Last verified: August 2012

July 9, 2012
August 5, 2012
July 2012
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Stent patency at 8 weeks after stent insertion
Same as current
Complete list of historical versions of study NCT01646476 on ClinicalTrials.gov Archive Site
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Covered Versus Uncovered Self-expandable Metallic Stents for Malignant Gastric Outlet Obstruction
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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Interventional
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Gastric Outlet Obstruction Due to Gastric Adenocarcinoma
  • Device: Covered stent (Bona stent pyloric/duodenal covered) insertion
  • Device: Uncovered stent (Bona stent, pyloric/duodenal) insertion
  • Active Comparator: Covered stent (Bona stent, pyloric/duodenal covered)
    Intervention: Device: Covered stent (Bona stent pyloric/duodenal covered) insertion
  • Active Comparator: Uncovered stent (Bona stent, pyloric/duodenal)
    Intervention: Device: Uncovered stent (Bona stent, pyloric/duodenal) insertion
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
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Inclusion Criteria:

  • age: 20-80
  • patients with gastric outlet obstruction due to gastric adenocarinoma
  • patients with inoperable gastric adenocarcinoma due to distant metastasis or severe comorbidity
  • Gastric outlet obstruction score: 0-2
  • Symptoms consistent with gastric outlet obstruction such as nausea or vomiting
  • Findings consistent with gastric outlet obstruction in upper endoscopy or abdominal computed tomography

Exclusion Criteria:

  • Previous history of stent insertion or endoscopic dilation for gastric outlet obstruction
  • previous history of bypass surgery for gastric outlet obstruction
  • Multiple level of bowel obstruction confirmed in radiographic studies such as small bowel series or abdominal computed tomography
  • Borrmann type IV advanced gastric cancer
Both
20 Years to 80 Years
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Contact: Byung-Hoon Min 82-2-3410-3409 jason1080.min@samsung.com
Korea, Republic of
 
NCT01646476
2012-01-075
No
Samsung Medical Center
Samsung Medical Center
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Samsung Medical Center
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP