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

Esophageal Cancer Clinical Trial

— StentMig  

Official title:

The Importance of Stent Design

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02166320
• Other study ID #: 2009/1034-31/3
• Secondary ID: 2009/1034-31/3
• Status: Completed
• Phase: Phase 2
• First received: June 16, 2014
• Last updated: January 4, 2017
• Start date: October 2010
• Est. completion date: April 2015

Study information

• Verified date: January 2017
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Swedish Research Council
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: April 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Device:
• Partially covered SEMS

• Fully covered SEMS

Locations

Country	Name	City	State
Sweden	Erik Johnsson	Gothenburg

Sponsors (4)

Lead Sponsor	Collaborator
Karolinska University Hospital	Blekinge County Council Hospital, Danderyd Hospital, Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SEMS dislocation in cm during first thirty days after stent insertion.		Thirty days from stent deployment.	Yes
Secondary	Health Related Quality of Life (HRQOL)		Within three months of SEMS deployment.	Yes
Secondary	Need for reintervention		Within three months after SEMS	Yes
Secondary	Grade of dysphagia within three months of SEMS.		Three months after insertion.	Yes