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CompletedNCT02166320StentMigUpdated Jan 5, 2017

Treatment of Malignant Strictures in Esophagus and Gastroesophageal Junction With Covered or Partially Covered Stent.

A Phase 2 interventional study of Partially covered SEMS and Fully covered SEMS in Esophageal Cancer, Cancer of Gastro Esophageal Junction and Palliative Treatment, sponsored by Karolinska University Hospital. Completed at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-01-05.

Sponsored by Karolinska University Hospital · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Esophageal Cancer
  • Cancer of Gastro Esophageal Junction
  • Palliative Treatment
03

In context

Lead sponsor

Karolinska University Hospital is the lead sponsor of 275 studies on the registry; 54 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Single (Participant)
Enrollment
80 participants (actual)

Study arms

  • Active comparator
    Partially covered SEMS

    Boston Scientific Ultraflex SEMS

    Device: Partially covered SEMS

  • Experimental
    Fully covered SEMS

    Boston Scientific Wallflex Esophageal SEMS.

    Device: Fully covered SEMS

Interventions

  • DevicePartially covered SEMS
  • DeviceFully covered SEMS
06

What researchers measure

Primary outcomes

  1. SEMS dislocation in cm during first thirty days after stent insertion.

    Time frame: Thirty days from stent deployment.

Secondary outcomes

  1. Health Related Quality of Life (HRQOL)

    Time frame: Within three months of SEMS deployment.

  2. Need for reintervention

    Time frame: Within three months after SEMS

  3. Grade of dysphagia within three months of SEMS.

    Time frame: Three months after insertion.

07

Study locations

1 site
  • Erik Johnsson
    Gothenburg, 41345, Sweden
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 5, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02166320
Lead sponsor
Karolinska University Hospital
Collaborators
Sahlgrenska University Hospital, Blekinge County Council Hospital, Danderyd Hospital
Responsible party
Lars Lundell (Professor, Karolinska University Hospital) — Principal investigator
First posted
Jun 18, 2014
Start date
Oct 2010
Primary completion
Jan 2015
Completion
Apr 2015
Last update
Jan 5, 2017

Study contacts

Erik Johnsson, MdPhd
principal investigator · Sahlgrenska University Hospital, Clinic of Surgery
Magnus Nilsson, ass professor
study chair · Karolinska University Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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