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

Safety and efficacy of a biodegradable stent during neoadjuvant therapy in patients with advanced esophageal cancer.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON20788

Enrollment

Registered

2011-06-08

Start date

2011-07-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysphagia and malnutrition in patients with advanced esophageal cancer receiving neoadjuvant chemoradiatian therapy

Interventions

Placement of a biodegradable uncovered stent across across a malignant stricture in the esophagus.

Eligibility

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
Safety defined as the absence of a stent-procedure- or stent-related major complication.	—

Secondary

Measure	Time frame
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).	—

Measure

Time frame

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).

—

Contacts

Public ContactM.W. Berg, van den

Academic Medical Center, Dept. of Gastroenterology & Hepatology Room C2-310

M.W.vandenBerg@amc.uva.nl+31 (0)20 5668708

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)