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: August 5, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention
Gastric Outlet Obstruction Due to Gastric Adenocarcinoma
Device: Covered stent (Bona stent pyloric/duodenal covered) insertion
Device: Uncovered stent (Bona stent, pyloric/duodenal) insertion

Study Type: Interventional
Official Title: Comparison of Efficacy of Covered Versus Uncovered Self-expandable Metallic Stents for Treatment of Malignant Gastric Outlet Obstruction: a Prospective, Randomized Study

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Stent patency at 8 weeks after stent insertion

Study Start Date: July 2012
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01646476

Contacts
Contact: Byung-Hoon Min 82-2-3410-3409 jason1080.min@samsung.com

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Byung-Hoon Min    82-2-3410-3409    jason1080.min@samsung.com   
Sponsors and Collaborators
Samsung Medical Center
  More Information

No publications provided

Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01646476     History of Changes
Other Study ID Numbers: 2012-01-075
Study First Received: July 9, 2012
Last Updated: August 5, 2012
Health Authority: South Korea: Institutional Review Board

Additional relevant MeSH terms:
Adenocarcinoma
Gastric Outlet Obstruction
Pyloric Stenosis
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 21, 2014