esophageal cancer esophageal carcinoma
Conditions
Interventions
The HILZO* Esophageal Stent system (BCM Co. Ltd.) is intended for maintaining
esophageal luminal patency in esophageal stricture. It is comprised of two
components
an implantable metallic stent and a flexible introducer system.
After the operation, the stent remains at the intended location, within the
patient while the introducer system is removed.
Delivery
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Non-operable malignant obstruction of the esophagus or esophagogastric junction, extrinsic malignant compression, or recurrent malignant dysphagia after esophagectomy. 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 • Recurrent dysphagia after prior radiation with curative or palliative intent for esophageal or gastric cardia cancer. • Requiring treatment for dysphagia (dysphagia score of 2-4, according to Ogilvie2) • Written informed consent • Age >= 18 years
Exclusion criteria
Exclusion criteria: • Inappropriate cultural level and understanding of the study. • Simultaneous participation in another clinical study • Life expectancy of less than 12 months • Stenosis after laryngectomy, or if the distance between the upper edge of the stent is less than 2 cm from the upper esophageal sphincter • Tumor length of more than 12cm • Coagulopathy • Previous stent placement for the same condition
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The evaluation of all study participants will be registered by the principal investigator. The primary objective will be the safety and efficacy of esophageal HILZO Covered stent. 1. Safety: complications during the follow-up period until death will be registered and evaluated (migration, food impaction, bleeding, esophageal perforation, etc.). 2. Efficacy: technical successful TTS placement of the esophageal HILZO Covered stent, correct positioning at the stenosis under endoscopic guidance. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Long-term efficacy (dysphagia) will be measured at baseline and during follow-up until death with the Ogilvie dysphagia score. 2. Pain during follow-up: the first two weeks pain will be measured daily with a patient diary, using the Visual Analogue Scale (VAS). After this, pain will be assessed with the VAS during follow-up. 3. The presence of hyperplastic reaction will be objectified if appropriate during endoscopic controls according to standard care. | — |
Countries
Netherlands
Outcome results
None listed