To investigate the safety and efficacy of a biodegradable esophageal stent during neoadjuvant therapy of patients diagnosed with resectable esophageal carcinoma.
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
- Gastrointestinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome measure is safety.
Secondary outcome
Secondary outcome measures are clinical succes, technical success, persistent
or recurrent dysphagia, complications and weight changes.
Background summary
Most of the patients with locally advanced esophageal cancer require
chemoradiotherapy therapy prior to curative resection. This neoadjuvant therapy
however often causes acute inflammation and oedema of the esophageal mucosa,
which will increase difficulties in swallowing and consequently further impair
dysphagia and the nutritional status of the patients. First data on a
self-expanding plastic stent (fully covered) showed promising results with
regard to improvement of dysphagia and safety during neoadjuvant therapy. There
were two main drawbacks; these stent tended to migrate and they had to be
removed prior to surgery. We hypothesized that an uncovered biodegradable stent
might refute these problems while the improvement of dysphagia remains.
Study objective
To investigate the safety and efficacy of a biodegradable esophageal stent
during neoadjuvant therapy of patients diagnosed with resectable esophageal
carcinoma.
Study design
Prospective, multi center, clinical study.
Intervention
Endoscopic placement of a biodegradable esophageal stent.
Study burden and risks
Patients will have to keep a dysphagia diary daily for the duration of the
study. Moreover they will be seen for follow-up and control by a research
fellow on a weekly basis in the outpatient clinic during the 5 week period of
radiotherapy. Thereafter patients will be contacted weekly by a research nurse
during the remaining period of follow-up. The major risks associated with
participation are perforation, haemorrhage and severe retrosternal pain. The
benefits will be a quick relief of dysphagia. No extra visits to the hospital
are foreseen.
Meibergdreef 9
1105 AZ Amsterdam
NL
Meibergdreef 9
1105 AZ Amsterdam
NL
Listed location countries
Age
Inclusion criteria
* cT1-3 N0-1 M0 esophageal carcinoma.
* Scheduled for neoadjuvant chemoradiation therapy prior to esophagectomy.
* Dysphagia for solid, semisolid or liquid food (dysphagia score 2, 3, 4).
* Age older then 18 years.
* Informed consent.
Exclusion criteria
* Tumor length of more than 10 cm.
* Tumor growth within 5 cm of the upper esophageal sphincter.
* Tumor extension into the stomach more than 5 cm.
* 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 | NL34625.018.10 |