Esophageal cancer, Dysphagia, Palliation, Migration, Stent
Conditions
Interventions
Placement of a novel fully covered stent with antimigration falps across a malignant stricture in the esophagus.
Sponsors
University Medical Center Utrecht (UMCU), Departement of Gastronenterology and Hepatology
Eligibility
Inclusion criteria
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; 3. Requiring treatment for dysphagia (dysphagia score of 2-4, according to Ogilvie); 4. Written informed consent.
Exclusion criteria
Exclusion criteria: 1. Evidence of tumor growth within 2 cm of the upper esophageal sphincter; 2. A tumor covering < 50% of the circumference; 3. Tumour length of more than 12 cm; 4. Previous treatment with a stent for the same condition; 5. WHO performance score of 4 (100% of time in bed); 6. Patients unfit to undergo conscious sedation; 7. Patients with a 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 |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 1. Functional outcome: dysphagia and WHO performance score; 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; 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; 4. Technical success; defined as ease of deployment and placement of the stent at the required location. | — |
Contacts
Public ContactD. Walter
P.O. Box 85500
Outcome results
None listed