Gastric Outlet Obstruction Due to Gastric AdenocarcinomaPhase 3NCT01646476
Covered Versus Uncovered Self-expandable Metallic Stents for Malignant Gastric Outlet Obstruction
A Phase 3 study testing Covered stent (Bona stent pyloric/duodenal covered) insertion and Uncovered stent (Bona stent, pyloric/duodenal) insertion in people with Gastric Outlet Obstruction Due to Gastric Adenocarcinoma, run by Samsung Medical Center at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Gastric Outlet Obstruction Due to Gastric Adenocarcinoma
- What is being tested?
- Covered stent (Bona stent pyloric/duodenal covered) insertion and Uncovered stent (Bona stent, pyloric/duodenal) insertion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2012to Dec 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Covered stent (Bona stent pyloric/duodenal covered) insertion, Uncovered stent (Bona stent, pyloric/duodenal) insertion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Covered stent (Bona stent pyloric/duodenal covered) insertionDevice
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.
Uncovered stent (Bona stent, pyloric/duodenal) insertionDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Covered stent (Bona stent, pyloric/duodenal covered) | Active comparator | WAVE covered self-expandable metallic stent (BONASTENT, Standard Sci Tech, Ltd., Seoul, Korea) Receives: Device: Covered stent (Bona stent pyloric/duodenal covered) insertion |
| Uncovered stent (Bona stent, pyloric/duodenal) | Active comparator | uncovered self-expandable metallic stent (BONASTENT, Standard Sci Tech, Ltd., Seoul, Korea) Receives: Device: Uncovered stent (Bona stent, pyloric/duodenal) insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stent patency
Measured: 8 weeks after stent insertion
Secondary outcomes (1)
Stent patency
Measured: 16 weeks after stent insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Outlet Obstruction Due to Gastric AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01646476
- Sponsor's protocol ID
- 2012-01-075
- Status last verified
- Feb 2017
- First submitted
- 9 Jul 2012
- Last updated
- 1 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy of Covered Versus Uncovered Self-expandable Metallic Stents for Treatment of Malignant Gastric Outlet Obstruction: a Prospective, Randomized Study
- ClinicalTrials.gov ID
- NCT01646476
- Acronym / sponsor ID
- 2012-01-075
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 20 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Covered stent (Bona stent, pyloric/duodenal covered) | Active comparator | Device: Covered stent (Bona stent pyloric/duodenal covered) insertionWAVE covered self-expandable metallic stent (BONASTENT, Standard Sci Tech, Ltd., Seoul, Korea) |
| Uncovered stent (Bona stent, pyloric/duodenal) | Active comparator | Device: Uncovered stent (Bona stent, pyloric/duodenal) insertionuncovered self-expandable metallic stent (BONASTENT, Standard Sci Tech, Ltd., Seoul, Korea) |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Covered stent (Bona stent pyloric/duodenal covered) insertionself-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 | Covered stent (Bona stent, pyloric/duodenal covered) |
| Uncovered stent (Bona stent, pyloric/duodenal) insertionSelf-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) |
Primary outcome
Stent patency
Time frame: 8 weeks after stent insertion
1 secondary outcome
Stent patency
Time frame: 16 weeks after stent insertion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2017.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Covered stent (Bona stent pyloric/duodenal covered) insertion and Uncovered stent (Bona stent, pyloric/duodenal) insertion in people with Gastric Outlet Obstruction Due to Gastric Adenocarcinoma, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stent patency (time frame: 8 weeks after stent insertion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2017.