To evaluate recurrent dysphagia, due to tissue overgrowth or migration, of the SX-Ella stent Esophageal HV in patients with dysphagia from inoperable carcinoma of the distal esophagus or cardia.
ID
Source
Brief title
Condition
- Gastrointestinal stenosis and obstruction
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Primary endpoint is the occurrence of recurrent dysphagia (stent migration,
tissue overgrowth) including the need for re-intervention.
Secondary outcome
- Secondary endpoints are functional outcome (dysphagia score), the occurrence
of complications and survival.
Background summary
In patients with inoperable esophageal or cardia cancer, restoration of the
ability to eat is the only possible therapy. The aim of palliative treatment is
to relief dysphagia rapidly with minimal or no hospital stay, to maintain
swallowing during life and to avoid serious complications. In the Netherlands,
in many patients with inoperable disease, single dose brachytherapy of
placement of a self-expanding metal stent are used for the palliation of
dysphagia. A drawback of stents is the occurrence of recurrent dysphagia due to
stent migration (12-18% of patients), or tissue overgrowth (approximately 35%
of patients).
A new stent, the SX-ELLA stent Esophageal HV (Dr. Karel Volence-Ella-CS, Hradec
Kralove, Tsjechië), has been developed for the palliation of malignant
dysphagia. The SX-ELLA stent Esophageal HV is delivered in a compressed form
inside an introducer sheath with a diameter of 20 Fr. The stent is braided of a
wire made of nickel-titanium alloy (nitinol), and is braided of one piece of
the wire which makes the stent ends non-traumatic, i.e. the stent does not
injure the esophageal wall during an actual deployment or reposition if
misplaced. The stent is essentially not different from other stent types, but
differs with some types (Ultraflex stent and Famingo Wallstent) in that it is
completely covered and has an anti-migration feature
Study objective
To evaluate recurrent dysphagia, due to tissue overgrowth or migration, of the
SX-Ella stent Esophageal HV in patients with dysphagia from inoperable
carcinoma of the distal esophagus or cardia.
Study design
This is a one-center, prospective follow-up study. In total, 40 consecutive
patients will be included who will be treated with a SX-Ella stent Esophageal
HV. Follow-up is until 6 months or until death.
Intervention
Endoscopic esophageal stent placement
Study burden and risks
Patients with dysphagia due to an inoperable carcinoma f the esophagus or
gastric cardia. The aim of stent placement is to relief dysphagia rapidly. It
is to be expected that patients with a SX-ELLA stent Esophageal HV experience
more or less the same burden, with similar risk of complications compared to
other stents currently used. In addition, it is to be expected that the SX-ELLA
stent Esophageal HV will minimize recurrent dysphagia dur to stent migration or
tissue overgrowth
Dr Molewaterplein 40
3015 GD Rotterdam
Nederland
Dr Molewaterplein 40
3015 GD Rotterdam
Nederland
Listed location countries
Age
Inclusion criteria
a.Inoperable malignant obstruction of the esophagus or cardia (a tumor is considered inoperable if the patient has local tumor infiltration in neighboring organs, distant metastases, or a poor general health due to serious concomitant disease).
b.Recurrent dysphagia after prior radiation with curative or palliative intent for esophageal cancer.
c.Signed informed consent.
Exclusion criteria
a.Evidence of tumor within 2 cm of the upper esophageal sphincter.
b.Esophagotracheal or -bronchial fistula or both.
c.Lesions longer than 12 cm.
d.WHO performance score of 4.
e.Lack of fitness for sedation (including known allergies).
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 | NL16206.078.07 |