- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02166320
Treatment of Malignant Strictures in Esophagus and Gastroesophageal Junction With Covered or Partially Covered Stent. (StentMig)
January 4, 2017 updated by: Lars Lundell, Karolinska University Hospital
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Gothenburg, Sweden, 41345
- Erik Johnsson
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Partially covered SEMS
Boston Scientific Ultraflex SEMS
|
|
Experimental: Fully covered SEMS
Boston Scientific Wallflex Esophageal SEMS.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
SEMS dislocation in cm during first thirty days after stent insertion.
Time Frame: Thirty days from stent deployment.
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Thirty days from stent deployment.
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Health Related Quality of Life (HRQOL)
Time Frame: Within three months of SEMS deployment.
|
Within three months of SEMS deployment.
|
Need for reintervention
Time Frame: Within three months after SEMS
|
Within three months after SEMS
|
Grade of dysphagia within three months of SEMS.
Time Frame: Three months after insertion.
|
Three months after insertion.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Erik Johnsson, MdPhd, Sahlgrenska University Hospital, Clinic of Surgery
- Study Chair: Magnus Nilsson, ass professor, Karolinska University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2010
Primary Completion (Actual)
January 1, 2015
Study Completion (Actual)
April 1, 2015
Study Registration Dates
First Submitted
June 16, 2014
First Submitted That Met QC Criteria
June 16, 2014
First Posted (Estimate)
June 18, 2014
Study Record Updates
Last Update Posted (Estimate)
January 5, 2017
Last Update Submitted That Met QC Criteria
January 4, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- 2009/1034-31/3 (Other Identifier: Ethical Review board, Karolinska Institute Stockholm)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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