Esophageal CancerPhase 2StentMigNCT02166320
Treatment of Malignant Strictures in Esophagus and Gastroesophageal Junction With Covered or Partially Covered Stent.
A Phase 2 study testing Partially covered SEMS and Fully covered SEMS in people with Esophageal Cancer and Cancer of Gastro Esophageal Junction, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
Self expandable stent (SEMS) constitutes the main palliative treatment in advanced esophageal cancer. The palliative effect of SEMS is immediate when it comes to relief of dysphagia. The duration of this effect is however questionable. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer, Cancer of Gastro Esophageal Junction, Palliative Treatment
- What is being tested?
- Partially covered SEMS and Fully covered SEMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2010to Apr 2015
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Verified Squamous Cell Carcinoma or Adenocarcinoma of esophagus or Gastro Esophageal Junction (GEJ)
- Age above 18 years.
- Dysphagia scoring grade two or worse
- Not amenable for curative treatment
- Informed consent to participate
Who cannot join
- Concomitant cancer disease
- Inability to comply with study protocol
- Previous stent treatment
- Proximal location of the tumour in the esophagus.
- Need for more than one stent deployment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Importance of Stent Design
Self expandable stent (SEMS) constitutes the main palliative treatment in advanced esophageal cancer. The palliative effect of SEMS is immediate when it comes to relief of dysphagia. The duration of this effect is however questionable. The design of SEMS can be of importance since the device can dislodge and as a consequence of that dysphagia recur. The hypothesis has therefore been formulated that a partially covered SEMS is associated with less tendency to dislocate as compared to those SEMS, recently developed, which are covered through their entire length.
- Being tested
- Partially covered SEMS, Fully covered SEMS
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partially covered SEMSDevice
Fully covered SEMSDevice
| Study group | Role | What they receive |
|---|---|---|
| Partially covered SEMS | Active comparator | Boston Scientific Ultraflex SEMS Receives: Device: Partially covered SEMS |
| Fully covered SEMS | Experimental | Boston Scientific Wallflex Esophageal SEMS. Receives: Device: Fully covered SEMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
SEMS dislocation in cm during first thirty days after stent insertion.
Measured: Thirty days from stent deployment.
Secondary outcomes (3)
Health Related Quality of Life (HRQOL)
Measured: Within three months of SEMS deployment.
Need for reintervention
Measured: Within three months after SEMS
Grade of dysphagia within three months of SEMS.
Measured: Three months after insertion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2014 (estimated)
- Study startOct 2010
- Primary completionJan 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sahlgrenska University Hospital, Blekinge County Council Hospital, Danderyd Hospital
- Responsible party
- Principal investigator, Lars Lundell, Karolinska University Hospital
- Investigators
- Erik Johnsson, MdPhd, Principal investigator, Sahlgrenska University Hospital, Clinic of SurgeryMagnus Nilsson, ass professor, Study chair, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02166320
- Sponsor's protocol ID
- 2009/1034-31/3
- Other IDs
- 2009/1034-31/3
- Acronym
- StentMig
- Status last verified
- Jan 2017
- First submitted
- 16 Jun 2014
- Last updated
- 5 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Importance of Stent Design
- ClinicalTrials.gov ID
- NCT02166320
- Acronym / sponsor ID
- StentMig / 2009/1034-31/3
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- Sahlgrenska University Hospital, Blekinge County Council Hospital, Danderyd Hospital
- Study start
- Oct 2010
- Primary completion
- Jan 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 18 Jun 2014 (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.
Self expandable stent (SEMS) constitutes the main palliative treatment in advanced esophageal cancer. The palliative effect of SEMS is immediate when it comes to relief of dysphagia. The duration of this effect is however questionable. The design of SEMS can be of importance since the device can dislodge and as a consequence of that dysphagia recur. The hypothesis has therefore been formulated that a partially covered SEMS is associated with less tendency to dislocate as compared to those SEMS, recently developed, which are covered through their entire length.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Partially covered SEMS | Active comparator | Device: Partially covered SEMSBoston Scientific Ultraflex SEMS |
| Fully covered SEMS | Experimental | Device: Fully covered SEMSBoston Scientific Wallflex Esophageal SEMS. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Verified Squamous Cell Carcinoma or Adenocarcinoma of esophagus or Gastro Esophageal Junction (GEJ)
- Age above 18 years.
- Dysphagia scoring grade two or worse
- Not amenable for curative treatment
- Informed consent to participate
Key exclusion criteria (5 listed)
- Concomitant cancer disease
- Inability to comply with study protocol
- Previous stent treatment
- Proximal location of the tumour in the esophagus.
- Need for more than one stent deployment.
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 |
|---|---|---|
| Partially covered SEMS | Device | Partially covered SEMS |
| Fully covered SEMS | Device | Fully covered SEMS |
Primary outcome
SEMS dislocation in cm during first thirty days after stent insertion.
Time frame: Thirty days from stent deployment.
3 secondary outcomes
Health Related Quality of Life (HRQOL)
Time frame: Within three months of SEMS deployment.
Need for reintervention
Time frame: Within three months after SEMS
Grade of dysphagia within three months of SEMS.
Time frame: Three months after 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 5 Jan 2017.
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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.
Erik Johnsson, MdPhd principal investigator
Sahlgrenska University Hospital, Clinic of Surgery
Magnus Nilsson, ass professor study chair
Karolinska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Partially covered SEMS and Fully covered SEMS in people with Esophageal Cancer and Cancer of Gastro Esophageal Junction, run by Karolinska University Hospital at 1 site in Sweden.
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 5 inclusion and 5 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 5 Jan 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 Sweden. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
SEMS dislocation in cm during first thirty days after stent insertion. (time frame: Thirty days from stent deployment.). 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 5 Jan 2017.