Clinical trial NCT01646476: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastric Outlet Obstruction Due to Gastric Adenocarcinoma
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2012-07-20
Enrollment: 102
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Stent patency
timeFrame: 8 weeks after stent insertion
Secondary outcomes:
measure: Stent patency
timeFrame: 16 weeks after stent insertion
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References: