To assess the feasibility and safety of endoscopic removal of the Niti-S Esophageal Covered Stent under general anesthesia prior to surgical excision of esophageal cancerous lesions, following an escalating time since placement of the stent of 2…
ID
Source
Brief title
Condition
- Gastrointestinal stenosis and obstruction
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Success rate in stent removal at each time interval (ITT population).
Secondary outcome
NA
Background summary
The Niti-S Esophageal Covered Stent is intended for maintaining esophageal
luminal patency in esophageal strictures caused by intrinsic and/or extrinsic
malignant tumors and occlusion of concurrent esophageal fistula. In the present
study, it will specifically be used for the relief of dysphagia due to
malignant esophageal stenosis prior to esophagectomy.
Study objective
To assess the feasibility and safety of endoscopic removal of the Niti-S
Esophageal Covered Stent under general anesthesia prior to surgical excision of
esophageal cancerous lesions, following an escalating time since placement of
the stent of 2 weeks to 4 months.
Study design
Prospective, single site, open-label pilot study
Intervention
Endoscopic placement and removal of the Niti-S Esophageal Covered Stent
Study burden and risks
Eligible patients (n=30) will receive a Niti-S esophageal covered stent during
gastroscopy under conscious sedation with midazolam (day 0 of the study). The
benefit of stent placement is the immediate restoration of esophageal patency
which will enable patients to eat normally and maintain or, hopefully, increase
their body-weight in the waiting period for esophagectomy. A nasogastric
feeding tube will therefore not be necessary. Potential (temporary)
side-effects of stent placement are retrosternal pain, esophageal bleeding and
perforation. Patients will be asked by telephone for their dysphagia score at
week 1 and 2 after stent placement. One month after placement of the stent
patients will visit the outpatient department for assessment of the dysplagia
score and measurement of body-weight. A blood sample will be taken for serum
albumin analysis at day 0 and day 28. Prior to stent placement, 28 days after
stenting and at the day the stent will be removed, patients will be asked to
fill out a quality of life questionnaire. A chest X-ray will be obtained
shortly after stent placement and shortly before stent removal. The stent will
be removed immediately prior the esophagectomy. So, the patient will then
already be under general anaesthesia.
Heidelberglaan 100
3584 CX UTRECHT
Nederland
Heidelberglaan 100
3584 CX UTRECHT
Nederland
Listed location countries
Age
Inclusion criteria
• Above 18 years of age
• Presenting with an esophageal or gastric cardia carcinoma, confirmed by a tumor histology report
• Requiring treatment for severe dysphagia due to stenosis, as confirmed by an endoscopic examination
• Patient is a candidate for esophageal surgery
• Patient is prepared to sign a study-specific Informed Consent
Exclusion criteria
- Device-related exclusion criteria :
• Esophageal strictures of benign etiology
• Active tumor bleeding lesions
• Patients who are contraindicated for endoscopy and/or surgery, or related testing and/or medications
• Esophageal strictures that need to be dilated to pass the endoscope or the stent delivery system
• Patients with esophago-jejunostomy (following gastrectomy)
• Patients with polypoid lesions;- Study-related exclusion criteria:
• Patients presenting with a highly-positioned esophageal tumor lesion (tumor must be at least 5 cm from upper esophageal sphincter, and the proximal end of the stent must be at least 2 cm from cricopharyngeal muscle)
• Patients with significant preexisting pulmonary or cardiac disease
• Patients at risk of respiratory problems (as confirmed by neck region ultrasound), or requiring tracheo-bronchal stenting
• Patients due for radiotherapy prior to surgery (stent to be placed at least 4 weeks after radiotherapy)
• Patients unwilling and/or unable to submit to follow-up assessments
• Patients unable to fill-out questionnaires
• Patients who are not scheduled for surgery within 2 weeks to 4 months from the stent placement procedure
• Concurrent treatment with an investigational device or drug within 4 weeks of stent placement
• Patients with poor mental condition (psychiatric or organ cerebral disease) rendering the subject unable to understand the nature, scope, and possible consequences of the study or mental retardation or language barrier such that the patient is unable to give informed consent.
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 | NL22012.041.08 |
| Other | volgt |