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

Phase 2

Completed

• Conditions: Esophageal Cancer; Palliative Treatment; Cancer of Gastro Esophageal Junction
• Interventions: Device: Partially covered SEMS; Device: Fully covered SEMS

• Registration Number: NCT02166320
• Lead Sponsor: Karolinska University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2014-06-16
• Study First Submitted QC: 2014-06-16
• Study First Posted: 2014-06-18
• Primary Completion: 2015-01
• Study Completion: 2015-04
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-04
• Last Update Posted: 2017-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Partially covered SEMS	Partially covered SEMS	Boston Scientific Ultraflex SEMS
Fully covered SEMS	Fully covered SEMS	Boston Scientific Wallflex Esophageal SEMS.

Primary Outcome Measures

Name	Time	Method
SEMS dislocation in cm during first thirty days after stent insertion.	Thirty days from stent deployment.

Secondary Outcome Measures

Name	Time	Method
Grade of dysphagia within three months of SEMS.	Three months after insertion.
Health Related Quality of Life (HRQOL)	Within three months of SEMS deployment.
Need for reintervention	Within three months after SEMS

Trial Locations

Locations (1)

Erik Johnsson; 🇸🇪 Gothenburg, Sweden