No registrations found.
ID
Source
Brief title
Health condition
Dysphagia and malnutrition in patients with advanced esophageal cancer receiving neoadjuvant chemoradiatian therapy
Intervention
Outcome measures
Primary outcome
Safety defined as the absence of a stent-procedure- or stent-related major complication.
Secondary outcome
1. 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).
Background summary
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.
Study objective
N/A
Study design
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.
Intervention
Placement of a biodegradable uncovered stent across across a malignant stricture in the esophagus.
Room C2-310
M.W. Berg, van den
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5668708
M.W.vandenBerg@amc.uva.nl
Room C2-310
M.W. Berg, van den
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5668708
M.W.vandenBerg@amc.uva.nl
Inclusion criteria
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.
Exclusion criteria
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.
Design
Recruitment
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 |
|---|---|
| NTR-new | NL2788 |
| NTR-old | NTR2928 |
| Other | METC AMC : 10/296 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |