Treatment of Malignant Strictures in Esophagus and Gastroesophageal Junction With Covered or Partially Covered Stent.
StentMig
The Importance of Stent Design
1 other identifier
interventional
80
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2010
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 16, 2014
CompletedFirst Posted
Study publicly available on registry
June 18, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedJanuary 5, 2017
January 1, 2017
4.3 years
June 16, 2014
January 4, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
SEMS dislocation in cm during first thirty days after stent insertion.
Thirty days from stent deployment.
Secondary Outcomes (3)
Health Related Quality of Life (HRQOL)
Within three months of SEMS deployment.
Need for reintervention
Within three months after SEMS
Grade of dysphagia within three months of SEMS.
Three months after insertion.
Study Arms (2)
Partially covered SEMS
ACTIVE COMPARATORBoston Scientific Ultraflex SEMS
Fully covered SEMS
EXPERIMENTALBoston Scientific Wallflex Esophageal SEMS.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Karolinska University Hospitallead
- Sahlgrenska University Hospitalcollaborator
- Blekinge County Council Hospitalcollaborator
- Danderyd Hospitalcollaborator
Study Sites (1)
Erik Johnsson
Gothenburg, 41345, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Erik Johnsson, MdPhd
Sahlgrenska University Hospital, Clinic of Surgery
- STUDY CHAIR
Magnus Nilsson, ass professor
Karolinska University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 16, 2014
First Posted
June 18, 2014
Study Start
October 1, 2010
Primary Completion
January 1, 2015
Study Completion
April 1, 2015
Last Updated
January 5, 2017
Record last verified: 2017-01