To compare a fully covered metal stent versus a partially covered metal stent in patients with dysphagia due to an incurable malignant stenosis of the esophagus or cardia.
ID
Source
Brief title
Condition
- Gastrointestinal stenosis and obstruction
- Gastrointestinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Recurrent dysphagia. This is defined as occurrence of dysphagia due to a stent
or tumour related cause such as tumor in- or overgrowth, stent migration or
food impaction.
Secondary outcome
Technical success of metal stent placement, clinical success defined as
improvement of dysphagia score, complication rate, quality of life and survival
Background summary
Adequate treatment of dysphagia is essential in palliative care of patients
with incurable esophageal cancer. Metal stent placement is a minimally invasive
procedure and is rapidly effective in relieving dysphagia. However, recurrent
dysphagia occurs in around 40% of patients. It has been demonstrated that metal
stents, which are covered with a membrane are effective in reducing the number
of reinterventions compared with metal stents without covering. Randomized
studies comparing fully covered metal stents with partially covered metal
stents are scarce.
Study objective
To compare a fully covered metal stent versus a partially covered metal stent
in patients with dysphagia due to an incurable malignant stenosis of the
esophagus or cardia.
Study design
Prospective, randomized controlled study with a follow-up of 6 months
Intervention
In one treatment group a fully covered metal stent will be placed. In the other
treatment group a partially covered metal stent will be inserted.
Study burden and risks
Patients will be contacted by telephone at regular intervals for assessing
questionnaires. In our opinion this will not put burden on patients
significantly. The randomisation between both types of stents will not expose
patients to additional risks. It is unclear which type of stent is preferable
with respect to risks and complications.
's Gravendijkwal 230
3015 CE Rotterdam
NL
's Gravendijkwal 230
3015 CE Rotterdam
NL
Listed location countries
Age
Inclusion criteria
Malignant stricture of the esophagus or cardia
No curative treatment options available
Dysphagia grade of at least 2 (able to swallow semi-solid soft foods)
Informed consent
Age * 18 years
Exclusion criteria
Previous treatment with self-expandable metal stent for same condition
Evidence of tumor within 2 cm of the upper esophageal sphincter.
Presence of an esophago-tracheal or -bronchial fistula or both.
Not able to undergo upper endoscopy
Design
Recruitment
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 | NL38111.078.11 |