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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Samsung Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01646476
First received: July 9, 2012
Last updated: May 25, 2015
Last verified: August 2012

July 9, 2012
May 25, 2015
July 2012
September 2015   (final data collection date for primary outcome measure)
Stent patency [ Time Frame: 8 weeks after stent insertion ] [ Designated as safety issue: No ]
Stent patency at 8 weeks after stent insertion
Complete list of historical versions of study NCT01646476 on ClinicalTrials.gov Archive Site
Stent patency [ Time Frame: 16 weeks after stent insertion ] [ Designated as safety issue: No ]
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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
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Gastric Outlet Obstruction Due to Gastric Adenocarcinoma
  • Device: Covered stent (Bona stent pyloric/duodenal covered) insertion
    self-expandable metallic stent placement was performed with a therapeutic endoscope (working channel ≥ 3.7 mm) using a through-the-scope method. All patients underwent procedures under conscious sedation with midazolam and pethidine. The length of the stricture was assessed either endoscopically or fluoroscopically; the length of the stent had to exceed that of the stricture by at least 3 cm. After the required stent length was determined, the stent was advanced through the endoscope over a guidewire until it passed across the distal end of the stricture. Then, the stent was deployed under continuous fluoroscopic control. For the Wave covered stent group, the stent was repositioned after deployment using the lasso under fluoroscopic guidance (if necessary), aligning the central portion of the stricture with the central portion of the stent which had reduced radial force and indentation. Stent positioning was confirmed endoscopically and fluoroscopically.
  • Device: Uncovered stent (Bona stent, pyloric/duodenal) insertion
    Self-expandable metallic stent placement was performed with a therapeutic endoscope (working channel ≥ 3.7 mm) using a through-the-scope method. All patients underwent procedures under conscious sedation with midazolam and pethidine. The length of the stricture was assessed either endoscopically or fluoroscopically; the length of the stent had to exceed that of the stricture by at least 3 cm. After the required stent length was determined, the stent was advanced through the endoscope over a guidewire until it passed across the distal end of the stricture. Then, the stent was deployed under continuous fluoroscopic control. For the Wave covered stent group, the stent was repositioned after deployment using the lasso under fluoroscopic guidance (if necessary), aligning the central portion of the stricture with the central portion of the stent which had reduced radial force and indentation. Stent positioning was confirmed endoscopically and fluoroscopically.
  • Active Comparator: Covered stent (Bona stent, pyloric/duodenal covered)
    WAVE covered self-expandable metallic stent (BONASTENT, Standard Sci Tech, Ltd., Seoul, Korea)
    Intervention: Device: Covered stent (Bona stent pyloric/duodenal covered) insertion
  • Active Comparator: Uncovered stent (Bona stent, pyloric/duodenal)
    uncovered self-expandable metallic stent (BONASTENT, Standard Sci Tech, Ltd., Seoul, Korea)
    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
102
November 2015
September 2015   (final data collection date for primary outcome measure)

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   (Adult, Senior)
No
Contact: Byung-Hoon Min 82-2-3410-3409 jason1080.min@samsung.com
Korea, Republic of
 
NCT01646476
2012-01-075
No
Not Provided
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Samsung Medical Center
Samsung Medical Center
Not Provided
Not Provided
Samsung Medical Center
August 2012

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