The goal of this study is to compare the efficacy and safety of the Wallflex stent to the Egis stent.
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Composite clinical end point of recurrent dysphagia and major complications due
to stent placement:
- Recurrent dysphagia is defined as a dysphagia score of >= 2 (according to
Ogilvie16) as a result of stent dysfunction after initial improvement of
dysphagia to < 2. Stent dysfunction is defined as stent migration, tumor in- or
overgrowth or food bolus impaction objectified during upper endoscopy.
- Major complications due to stent placement are defined as complications
leading to hospitalization, unintended prolongation of hospitalization, death
or repeat endoscopic intervention with a possible or definite association with
stent placement as determined by the treating physician.
Secondary outcome
-Technical success; defined as an easy deployment and placement of the stent at
the required location, verified by fluoroscopy and/or endoscopy.
-Pain score during the first 14-days after stent placement; scored by the
patient on a visual analogue scale (VAS).
-Unrelated major complications
-Minor complications
-Quality of life (EQ5D)
Background summary
Dysphagia is a frequently encountered problem in patients with a malignancy of
or around the esophagus. At presentation, surgery is not possible in >50% of
patients. Palliative therapy is the only option then. The main goal of
palliative treatment is to provide rapid and persistent relief of dysphagia.
For this, endoscopic placement of a self-expandable metal stent (SEMS) is one
of the most evidence-based treatment options. Although a large selection of
SEMS is currently available, recurrent dysphagia due to stent migration, tumor
in- or overgrowth or food bolus impaction remains a problem. The fully covered
(FC) Egis stent has been developed to reduce the incidence of recurrent
dysphagia as well as the complication rate. We hypothesize that the Egis stent,
which is more flexible than the Wallflex stent and has a double stepped
shoulder design, leads to less complications and less often to recurrent
dysphagia compared to the often used FC Wallflex stent.
Study objective
The goal of this study is to compare the efficacy and safety of the Wallflex
stent to the Egis stent.
Study design
multicenter, randomized controlled trial in four Dutch hospitals. Patients will
be randomized to receive a FC Wallflex stent or FC Egis stent. FU is done by
telephone after 2 weeks, 4 weeks and then monthly for up to 6 months after the
procedure, death or stent removal
Intervention
FC Wallflex stent or FC Egis stent
Study burden and risks
-Technical success; defined as ease of deployment and placement of the stent at
the required location and verified by fluoroscopy and/or endoscopy.
-Pain score during the first 14-days after stent placement; scored by the
patient on a visual analogue scale (VAS).
-Major complications not related to stent placement; defined as complications
leading to hospitalization, unintended prolongation of hospitalization, death
or repeat endoscopic intervention without a possible or definite association
with stent placement as determined by the treating physician.
-Minor complications due to stent placement; defined as minor complications
with a possible or definite association with stent placement as determined by
the treating physician
-Minor complications not related to stent placement; defined minor
complications without a possible or definite association with stent placement
as determined by the treating physician.
-Quality of life; measured with the EQ5D questionnaire
Heidelberglaan 100
Utrecht 3584CX
NL
Heidelberglaan 100
Utrecht 3584CX
NL
Listed location countries
Age
Inclusion criteria
-Dysphagia due to an inoperable malignant obstruction of the esophagus or gastric cardia. Dysphagia is defined as: dysphagia score of 2-4, according to Ogilvie. Inoperable disease is defined as local tumor infiltration into surrounding organs, distant metastases or a poor general health due to serious concomitant disease
-Written informed consent
Exclusion criteria
-Evidence of tumor growth within 2 cm of the upper esophageal sphincter
-Tumor length > 12 cm
-Previous stent placement for the same condition
-Karnofsky performance scale of <40%
-Patients unfit to undergo conscious sedation
-Patients with a poor mental condition or mental retardation, unable to understand the nature and possible consequences of the study or unwilling to undergo follow-up assessments
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL45348.041.13 |