The aim of this study is to evaluate the safety and efficacy of the esophageal partially covered SEMS. We will pay specific attention to recurrent dysphagia rates, migration rates and pain.
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
- Safety: Short term (within 7 days after treatment) and long term (after 7
days) major complications and minor complications. Major complications are
defined as life threatening and severe complications such as perforation,
hemorrhage, fistula formation and severe pain. Minor complications are defined
as non-life threatening, moderately severe pain or gastroesophageal reflux and
stent migration.
- Efficacy: Consisting of:
• Clinical outcome, measured at baseline and during follow-up until death with
the Ogilvie dysphagia score;
•Technical successful placement of the esophageal partially covered SEMS
including correct positioning at the stenosis. Technical success is defined as
ease of deployment and placement of the stent at the required location.
All primary study parameters will be compared to our historical stent cohort
consisting of 997 patients that underwent self-expandable metal stent placement
due to an incurable esophageal stricture from July 1994 to May 2017.
Secondary outcome
- Recurrent dysphagia: cause of dysphagia will be registered during follow-up;
- Pain related to esophageal stent during follow-up: the first two weeks pain
will be measured daily with a patient diary, using the Visual Analogue Scale
(VAS). After this, every 4 weeks until death the patient will be contacted with
a telephone interview;
- Overall survival.
All secundary study parameters will be compared to our historic stent cohort
consisting of 997 patients that underwent self-expandable metal stent placement
due to an incurable esophageal stricture from July 1994 to May 2017.
Background summary
More than 50% of esophageal cancer patients have unresectable disease at
presentation (1). Even after curative therapy, about 20% of patients develop
dysphagia from recurrent strictures. Dysphagia is the predominant symptom in
70% of esophageal cancer. Complications include high risk of aspiration and
reduced patency of the orogastric pathway, which lead to a profound reduction
in quality of life. Therefore, palliative therapy has been, and will continue
to remain, an important part of the management of esophageal malignancy. The
primary goal of palliative treatment in patients with esophageal cancer is to
achieve adequate improvement of dysphagia and therefore quality of life, with a
reduced need for additional interventions.
Although optimal intervention for treatment of dysphagia has yet to be
established, placement of a partially or fully covered self-expandable metal
stents (SEMS) is the palliative modality of choice and recommended by the
European Society of Gastrointestinal Endoscopy (1). This because of their
ability to provide instant, long-lasting relief from dysphagia with minimal
morbidity and negligible mortality (2).
The SEMS (Leufen Esophageal aixstent®) has been evaluated for palliation of
malignant dysphagia and has been approved with a Conformité Européenne (CE)
certificate for the maintenance of esophageal lumen patency in malignant
dysphagia.
Since there is limited data on the effectiveness in the clinical context, the
aim of this study is to evaluate the safety and efficacy of the esophageal
SEMS (Leufen aixstent OES®) compared to our historic stent cohort. We will pay
specific attention to recurrent dysphagia rates, migration rates and pain.
References:
1. Spaander MC, van der Bogt RD, Baron TH, et al. Esophageal stenting for
benign and malignant disease: European Society of Gastrointestinal Endoscopy
(ESGE) Guideline - Update 2021. Endoscopy. 2021 Jul;53(7):751-762.
2. Juan Carlos Martinez, Matthew M. Puc, and Roderick M. Quiros, Esophageal
Stenting in the Setting of Malignancy; ISRN Gastroenterology Volume 2011,
Article ID 719575.
Study objective
The aim of this study is to evaluate the safety and efficacy of the esophageal
partially covered SEMS. We will pay specific attention to recurrent dysphagia
rates, migration rates and pain.
Study design
Single center, prospective, observational clinical study.
Intervention
All patients will be treated with the esophageal self-expandable nitinol stent
(Leufen Esophageal aixstent®).
Study burden and risks
- Procedure: gastroscopy with stentplacement
- Follow-up: de first 2 weeks pain will be measured through a daily paindiary
using the Visual Analogue Scale (VAS). After 3, 7, 14 and 28 days and hereafter
every 4 weeks a telephone interview by the coordinating researcher will be
conducted until death to ask for symptoms of dysphagia and pain.
Risk:
The risk classification is determined as negligible based on the guideline of
the *Nederlandse Federatie van Universitair Medische Centra*. The risks
associated with the participation in the study are similar to the risks of
treatment with any esophageal stent, and do not different from the
complications arising from the use of other expandable stent; migration,
bleeding, perforation and development of hyperplasia/granulation tissue. The
Leufen aixstent OES is standard treatment in the Erasmus MC for malignant
strictures, meaning that the risks participating patients are exposed to is
similar to patients with a malignant stenosis that do not participate.
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
- Patients presenting with dysphagia due to an incurable malignant obstruction
of the esophagus or esophagogastric junction including extrinsic malignant
compression and recurrence in post-esophagectomy patients;
- Requiring treatment for dysphagia (Ogilvie score of 2-4);
- Life expectancy of less than 12 months;
- Written informed consent;
- Age >= 18 years;
Exclusion criteria
- Stenosis after laryngectomy;
- Distance between the upper edge of the stent less than 2 cm from the upper
esophageal sphincter;
- Tumor length of more than 14 cm;
- Previous stent placement for the same condition;
- Inability to discontinue anticoagulants or high-dose antiplatelet drugs at
time of the baseline procedure (low-dose aspirin (max. 100 mg/day) may be
continued);
- Known clotting disorder that cannot be corrected pre-procedural;
- Esophageal varices;
- Disorders of the physiological swallowing function.
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 | NL86416.078.24 |