TTS Esophageal HILZO Stent: A Safety and Feasibility Study

TTS Esophageal HILZO Covered Self-expandable Metal Stent for Palliation of Malignant Dysphagia: A Safety and Feasibility Study

A multicenter non-randomized prospective clinical study assessing the safety and feasibility of the esophageal through-the-scope HILZO Covered self-expandable metal stent placement for palliation of malignant dysphagia

The main objective of this study is to evaluate the safety and efficacy of placement of the esophageal HILZO Covered stent with the TTS method in patients with non-operable malignant obstruction of the esophagus or esophagogastric junction, extrinsic malignant compression, or recurrent malignant dysphagia after esophagectomy.

Other (secondary) objects are to assess the effect of the stent on the presence of hyperplastic reaction after implantation, the functional complications and survival.

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, according to Ogilvie2)
• Written informed consent
• Age ≥ 18 years

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
• Previous stent placement for the same condition