TTS Esophageal HILZO Stent: A Safety and Feasibility Study

Radboud University Medical Center

Status: Unknown

Conditions: Esophagus Cancer

Treatments: Device: HILZO esophageal stent

Study type: Interventional

Funder types: Other

Identifiers

NCT03269903

NL.59951.091.16

Details and patient eligibility

About

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

Full description

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Patients

Experimental group

Description:

Patients with malignant dysphagia treated with the HILZO stent

Treatment:

Device: HILZO esophageal stent