Skip to main content
OpenTrials
Completed

NCT Number: NCT02166320

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Esophageal Cancer Cancer of Gastro Esophageal Junction Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site Palliative Treatment

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Erik Johnsson

Gothenburg, 41345, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Partially covered SEMS

Device

Fully covered SEMS

Device

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.

Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Collaborators

  • Blekinge County Council Hospital
  • Danderyd Hospital
  • Sahlgrenska University Hospital

Registry information

Official study title

The Importance of Stent Design

Acronym: StentMig

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Jun 18, 2014
Registry last updated
Jan 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.