Clinical trial NCT03269903: TTS Esophageal HILZO Stent: A Safety and Feasibility Study
Official title: TTS Esophageal HILZO Covered Self-expandable Metal Stent for Palliation of Malignant Dysphagia: A Safety and Feasibility Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Esophagus Cancer
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Kebomed B.V.
First posted: 2017-09-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Multicenter non-randomized prospective clinical study in 30 patients with malignant dysphagia
Primary purpose: TREATMENT

Brief summary: 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

Detailed 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.

Eligibility 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, 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

Primary outcomes:
measure: Incidence of treatment associated adverse events during follow-up (safety)
timeFrame: 1 year
measure: Through-the-scope stent placement (feasibility): (1) ease of deployment at intended esophageal location
timeFrame: 1 day
measure: Through-the-scope stent placement (feasibility): incidence of device related adverse device events at moment of stent placement
timeFrame: 1 day
Secondary outcomes:
measure: Dysphagia, measured with the Ogilvie Dysphagia score (functional outcome)
timeFrame: 6 months
measure: Retrosternal pain related to esophageal stent, measured with the Visual Analog Scale (functional outcome)
timeFrame: 6 months
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboudumc
state: Gelderland
Study officials:
affiliation: Radboud University Medical Center
name: Peter Siersema, professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vermeulen BD, Reijm AN, van der Bogt RD, van Hooft JE, Spaander MCW, Siersema PD. Through-the-scope placement of a fully covered metal stent for palliation of malignant dysphagia: a prospective cohort study (with video). Gastrointest Endosc. 2019 Dec;90(6):972-979. doi: 10.1016/j.gie.2019.06.030. Epub 2019 Jun 29.