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

NCT ID: NCT02166320

Last Updated: 2017-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2015-04-30

Brief Summary

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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

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Conditions

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Esophageal Cancer Cancer of Gastro Esophageal Junction Palliative Treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Partially covered SEMS

Boston Scientific Ultraflex SEMS

Group Type ACTIVE_COMPARATOR

Partially covered SEMS

Intervention Type DEVICE

Fully covered SEMS

Boston Scientific Wallflex Esophageal SEMS.

Group Type EXPERIMENTAL

Fully covered SEMS

Intervention Type DEVICE

Interventions

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Partially covered SEMS

Intervention Type DEVICE

Fully covered SEMS

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sahlgrenska University Hospital

OTHER

Sponsor Role collaborator

Blekinge County Council Hospital

OTHER

Sponsor Role collaborator

Danderyd Hospital

OTHER

Sponsor Role collaborator

Karolinska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Lars Lundell

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Erik Johnsson, MdPhd

Role: PRINCIPAL_INVESTIGATOR

Sahlgrenska University Hospital, Clinic of Surgery

Magnus Nilsson, ass professor

Role: STUDY_CHAIR

Karolinska University Hospital

Locations

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Erik Johnsson

Gothenburg, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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2009/1034-31/3

Identifier Type: OTHER

Identifier Source: secondary_id

2009/1034-31/3

Identifier Type: -

Identifier Source: org_study_id

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