Covered Versus Uncovered Self-expandable Metallic Stents for Malignant Gastric Outlet Obstruction
Primary Purpose
Gastric Outlet Obstruction Due to Gastric Adenocarcinoma
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Covered stent (Bona stent pyloric/duodenal covered) insertion
Uncovered stent (Bona stent, pyloric/duodenal) insertion
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Outlet Obstruction Due to Gastric Adenocarcinoma
Eligibility 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
Sites / Locations
- Samsung Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Covered stent (Bona stent, pyloric/duodenal covered)
Uncovered stent (Bona stent, pyloric/duodenal)
Arm Description
WAVE covered self-expandable metallic stent (BONASTENT, Standard Sci Tech, Ltd., Seoul, Korea)
uncovered self-expandable metallic stent (BONASTENT, Standard Sci Tech, Ltd., Seoul, Korea)
Outcomes
Primary Outcome Measures
Stent patency
Secondary Outcome Measures
Stent patency
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01646476
Brief Title
Covered Versus Uncovered Self-expandable Metallic Stents for Malignant Gastric Outlet Obstruction
Official Title
Comparison of Efficacy of Covered Versus Uncovered Self-expandable Metallic Stents for Treatment of Malignant Gastric Outlet Obstruction: a Prospective, Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samsung Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Outlet Obstruction Due to Gastric Adenocarcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Covered stent (Bona stent, pyloric/duodenal covered)
Arm Type
Active Comparator
Arm Description
WAVE covered self-expandable metallic stent (BONASTENT, Standard Sci Tech, Ltd., Seoul, Korea)
Arm Title
Uncovered stent (Bona stent, pyloric/duodenal)
Arm Type
Active Comparator
Arm Description
uncovered self-expandable metallic stent (BONASTENT, Standard Sci Tech, Ltd., Seoul, Korea)
Intervention Type
Device
Intervention Name(s)
Covered stent (Bona stent pyloric/duodenal covered) insertion
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Uncovered stent (Bona stent, pyloric/duodenal) insertion
Intervention Description
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.
Primary Outcome Measure Information:
Title
Stent patency
Time Frame
8 weeks after stent insertion
Secondary Outcome Measure Information:
Title
Stent patency
Time Frame
16 weeks after stent insertion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Covered Versus Uncovered Self-expandable Metallic Stents for Malignant Gastric Outlet Obstruction
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