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Veiligheid en effectiviteit van plaatsing van een biologisch afbreekbare stent in de slokdarm tijdens chemoradiatie therapie.


- candidate number9697
- NTR NumberNTR2928
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR8-jun-2011
- Secondary IDs10/296 METC AMC
- Public TitleVeiligheid en effectiviteit van plaatsing van een biologisch afbreekbare stent in de slokdarm tijdens chemoradiatie therapie.
- Scientific TitleSafety and efficacy of a biodegradable stent during neoadjuvant therapy in patients with advanced esophageal cancer.
- ACRONYMEsNeBio
- hypothesisN/A
- Healt Condition(s) or Problem(s) studiedEsophageal cancer, Dysphagia, Malnutrition, Neoadjuvant chemoradiatian
- Inclusion criteria1. 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.
- Exclusion criteria1. 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-jul-2011
- planned closingdate1-jul-2012
- Target number of participants16
- InterventionsPlacement of a biodegradable uncovered stent across across a malignant stricture in the esophagus.
- Primary outcomeSafety defined as the absence of a stent-procedure- or stent-related major complication.
- Secondary outcome1. Technical succes: Successful stent placement and deployment at the site of the stricture;
2. Clinical success: Improvement of the mean dysphagia score during total follow-up;
3. Persistent dysphagia: No improvement from baseline dysphagia score after 1 week of follow-up;
4. Recurrent dysphagia: Reoccurrence of a dysphagia score of 2 or more during 3 consecutive days;
5. Complications (stent-procedure or stent related):
A. Major: Perforation, hemorrhage requiring blood transfusion (at least 2 units), severe retrosternal pain requiring treatment with intravenous morfinomimetics for over 48 hours;
B. Minor: Moderate retrosternal pain (no morfinomimetica needed for over 48 hours), heartburn, regurgitation, re-obstruction caused by food-impaction, tumor in- or overgrowth or tissue hyperplasia.
6. Weight changes: Measured in kilograms of bodyweight and BMI and changes in body fat distribution, lean body mass and body cell mass measured by bio-elelectrical impedance analysis (BIA) and by screening for malnutrition using the Malnutrition Universal Screening Tool score (MUST-score).
- Timepoints1. 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.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESMD. M.W. Berg, van den
- CONTACT for SCIENTIFIC QUERIESMD. Jeanin Hooft, van
- Sponsor/Initiator Academic Medical Center (AMC), Department of Hepato- and Gastroenterology
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- PublicationsN/A
- Brief summaryMost 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.
- Main changes (audit trail)
- RECORD8-jun-2011 - 24-jun-2011


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