N/A
ID
Bron
Verkorte titel
Aandoening
Dysphagia and malnutrition in patients with advanced esophageal cancer receiving neoadjuvant chemoradiatian therapy
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Safety defined as the absence of a stent-procedure- or stent-related major complication.
Achtergrond van het onderzoek
Most of the patients with locally advanced esophageal cancer receive 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 may consequently further impair dysphagia and jeopardize the nutritional status of the patients. First data on a self-expanding plastic stent (fully covered) placed prior to chemoradiotherapy showed promising results with regard to improvement of dysphagia and safety. There were two main drawbacks; stent migration and the need for removal prior to surgery. We hypothesized that an uncovered biodegradable stent might refute these problems while the improvement of dysphagia remains. Therefore the objective of this prospective multicenter study is to investigate the safety and efficacy of a biodegradable uncovered expandable stent placement prior to neoadjuvant therapy of patients diagnosed with resectable esophageal carcinoma.
Doel van het onderzoek
N/A
Onderzoeksopzet
1. Baseline characteristics, at day of stent placement;
2. Painscore 1 and 2 days after stent placement;
3. Dysphagia score 1 week after stent placement and thereafter weekly until esophagectomy;
4. Weight changes: Dependent of conversation with dietician.
Onderzoeksproduct en/of interventie
Placement of a biodegradable uncovered stent across across a malignant stricture in the esophagus.
Publiek
Room C2-310
M.W. Berg, van den
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5668708
M.W.vandenBerg@amc.uva.nl
Wetenschappelijk
Room C2-310
M.W. Berg, van den
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5668708
M.W.vandenBerg@amc.uva.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. T1-3N0-1M0 esophageal carcinoma;
2. Scheduled for neoadjuvant chemoradiation therapy prior to esophagectomy;
3. Dysphagia for solid, semisolid or liquid food (dysphagia score 2, 3 or 4);
4. Age 18 years and older;
5. Informed consent.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Tumor length > 10 cm;
2. Tumor growth within 5 cm of the upper esophageal sphincter;
3. Tumor extension into the stomach for more than 5 cm;
4. Poor mental condition or mental retardation, unable to understand the nature and possible consequences of the study or unwilling to undergo follow-up assessments.
Opzet
Deelname
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In overige registers
Register | ID |
---|---|
NTR-new | NL2788 |
NTR-old | NTR2928 |
Ander register | METC AMC : 10/296 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |