Evaluatie van stent plaatsing bij patiënten met voedselpassageklachten ten gevolge van een kwaadaardige slokdarmvernauwing.
Recruiting
- Conditions
- Esophageal cancer, Dysphagia, Palliation, Migration, Stent
- Registration Number
- NL-OMON26240
- Lead Sponsor
- niversity Medical Center Utrecht (UMCU), Departement of Gastronenterology and Hepatology
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion Criteria
1. Inoperable malignant obstruction of the esophagus or esophagogastric junction caused by esophageal or cardia carcinoma or extrinsic malignant compression. A tumor is considered inoperable if the patient has local tumor infiltration in the surrounding organs, distant metastases or a poor general health due to serious concomitant disease, OR;
2. Recurrent dysphagia after prior radiation with curative or palliative intent for esophageal or gastric cardia cancer;
Exclusion Criteria
1. Evidence of tumor growth within 2 cm of the upper esophageal sphincter;
2. A tumor covering < 50% of the circumference;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Migration rate after stent placement; defined as the number of patients presenting with recurrence of dysphagia or other complaints due to stent migration, observed during upper endoscopy.
- Secondary Outcome Measures
Name Time Method 1. Functional outcome: dysphagia and WHO performance score;<br /><br>2. Short term treatment and long term major complications and minor complications. Major complications are defined as life threatening and severe complications such as perforation, haemorrhage, fistula formation and severe pain. Minor complications are defined as non-life threatening or moderately severe pain and gastroesophageal reflux;<br /><br>3. Reurrent dysphagia; defined as occurrence of tissue ingrowth or overgrowth due to malignant or nonmalignant tissue, stent migration, and food bolus obstruction causing dysphagia needing second;<br /><br>4. Technical success; defined as ease of deployment and placement of the stent at the required location.