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

Karolinska University Hospital

Status and phase: Completed; Phase 2

Conditions: Esophageal Cancer; Palliative Treatment; Cancer of Gastro Esophageal Junction

Treatments: Device: Fully covered SEMS; Device: Partially covered SEMS

Study type: Interventional

Funder types: Other

Identifiers

NCT02166320

2009/1034-31/3 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Partially covered SEMS

Active Comparator group

Description:

Boston Scientific Ultraflex SEMS

Treatment:

Device: Partially covered SEMS

Fully covered SEMS

Experimental group

Description:

Boston Scientific Wallflex Esophageal SEMS.

Treatment:

Device: Fully covered SEMS