Gastric CancerPhase 3NCT02784470
Study of Gastroduodenal Metallic Stent vs Gastrojejunostomy
A Phase 3 study testing gastroduodenal stent placement and gastrojejunostomy in people with Gastric Cancer, run by Asan Medical Center at 1 site in South Korea.
Trial summary
Selection of the optimal treatment for gastric outlet obstruction in patients with radically unresectable gastric cancer remains controversial because previous studies comparing the two procedures had a small sample size as well as they included various etiologies such as gastrointestinal (GI) cancer, duodenal cancer… Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- gastroduodenal stent placement and gastrojejunostomy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2015to Jan 2020
- 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged ≥19 to 80 years
- ECOG performance status 0-3
- Life expectancy >3 months
- Patients with malignant gastric outlet obstruction (distal part of stomach, pyloric ring or duodenal bulb obstruction) caused by gastric cancer
- Patients who are not eligible for radical operation due to local progression of gastric cancer, distant metastasis or his/her general condition.
- Patients with GOOSS score 0-2
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- Patients with symptoms consistent with gastric outlet obstruction including persistent nausea and vomiting
- Patients with findings consistent with malignant gastric outlet obstruction on imaging studies including upper GI endoscopy, upper GIseries or abdominal computed tomography (CT)
- Patients who are eligible to undergo both gastroduodenal stent placement and gastrojejunostomy (eligibility will be determined by agreement by at least one gastroenterological surgeon and at least one radiologist)
- Patients who have been provided with an explanation of the procedures of the clinical trial, voluntarily decided participation and signed the informed consent form
Who cannot join
- Pregnant or lactating women
- Women of childbearing potential with positive pregnancy test at baseline. Post-menopausal women should have at least 12 months of amenorrhea to be considered not of childbearing potential.
- Patients who have previously undergone balloon dilatation or stent placement for malignant gastric outlet obstruction
- Patients with past history of palliative bypass surgery or gastrectomy
- Patients with peritoneal metastasis or multiple intestinal obstruction caused by other cause on imaging scan including abdominal CT or small bowel series
- Patients who have been treated for intestinal adhesion caused by previous abdominal surgery
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- Patients who are not eligible for general anesthesia due to poor general condition
- Patients with clinical evidence of intestinal perforation or peritonitis
- Patients who are determined to be not eligible for stent placement or gastrojejunostomy due to other cause
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Asan Medical Center
Seoul, 138-736
About this study
Selection of the optimal treatment for gastric outlet obstruction in patients with radically unresectable gastric cancer remains controversial because previous studies comparing the two procedures had a small sample size as well as they included various etiologies such as gastrointestinal (GI) cancer, duodenal cancer and pancreaticobiliary cancer in selecting the patient population. Therefore, to establish the standard of care for patients with radically unresectable gastric cancer with gastric outlet obstruction, a larger prospective, randomized, controlled clinical trial using a single type of stent is warranted.
- Conditions
- Gastric Cancer
- Being tested
- gastroduodenal stent placement, gastrojejunostomy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gastroduodenal stent placementDevice
gastrojejunostomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| gastrojejunostomy arm | Experimental | Not described Receives: Procedure: gastrojejunostomy |
| gastroduodenal stent placement | Active comparator | Not described Receives: Device: gastroduodenal stent placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric Outlet Obstruction Scoring System (GOOSS) score
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2016 (estimated)
- Study startOct 2015
- Primary completionJan 2018 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Asan 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
- None (open label)
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moon-Won Yoo, Asan Medical Center
- Investigators
- Yoomoon Won, MD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02784470
- Sponsor's protocol ID
- 20151141
- Status last verified
- May 2016
- First submitted
- 19 May 2016
- Last updated
- 27 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Gastroduodenal Metallic Stent vs Gastrojejunostomy
- ClinicalTrials.gov ID
- NCT02784470
- Acronym / sponsor ID
- 20151141
- Conditions
- Gastric Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 27 May 2016 (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.
Selection of the optimal treatment for gastric outlet obstruction in patients with radically unresectable gastric cancer remains controversial because previous studies comparing the two procedures had a small sample size as well as they included various etiologies such as gastrointestinal (GI) cancer, duodenal cancer and pancreaticobiliary cancer in selecting the patient population. Therefore, to establish the standard of care for patients with radically unresectable gastric cancer with gastric outlet obstruction, a larger prospective, randomized, controlled clinical trial using a single type of stent is warranted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| gastrojejunostomy arm | Experimental | Procedure: gastrojejunostomy |
| gastroduodenal stent placement | Active comparator | Device: gastroduodenal stent placement |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients aged ≥19 to 80 years
- ECOG performance status 0-3
- Life expectancy >3 months
- Patients with malignant gastric outlet obstruction (distal part of stomach, pyloric ring or duodenal bulb obstruction) caused by gastric cancer
- Patients who are not eligible for radical operation due to local progression of gastric cancer, distant metastasis or his/her general condition.
Key exclusion criteria (9 listed)
- Pregnant or lactating women
- Women of childbearing potential with positive pregnancy test at baseline. Post-menopausal women should have at least 12 months of amenorrhea to be considered not of childbearing potential.
- Patients who have previously undergone balloon dilatation or stent placement for malignant gastric outlet obstruction
- Patients with past history of palliative bypass surgery or gastrectomy
- Patients with peritoneal metastasis or multiple intestinal obstruction caused by other cause on imaging scan including abdominal CT or small bowel series
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 |
|---|---|---|
| gastroduodenal stent placement | Device | gastroduodenal stent placement |
| gastrojejunostomy | Procedure or surgery | gastrojejunostomy arm |
Primary outcome
Gastric Outlet Obstruction Scoring System (GOOSS) score
Time frame: Up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2016.
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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.
Yoomoon Won, MD principal investigator
Asan Medical Center
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 gastroduodenal stent placement and gastrojejunostomy in people with Gastric Cancer, run by Asan 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 10 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 27 May 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yoomoon Won, MD (82-2-3010-3484, medigang@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastric Outlet Obstruction Scoring System (GOOSS) score (time frame: Up to 2 years). 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 27 May 2016.