Back to resultsTTS Esophageal HILZO Stent: A Safety and Feasibility Study (HILZO)
Primary Purpose
Esophagus Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
HILZO esophageal stent
Sponsored by
About this trial
This is an interventional treatment trial for Esophagus Cancer
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
Sites / Locations
- RadboudumcRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients
Arm Description
Patients with malignant dysphagia treated with the HILZO stent
Outcomes
Primary Outcome Measures
Incidence of treatment associated adverse events during follow-up (safety)
Short term (within 7 days after treatment) and long term (after 7 days) 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.
Through-the-scope stent placement (feasibility): (1) ease of deployment at intended esophageal location
Technical success is defined as ease of through-the-scope deployment and placement of the stent at the required esophageal location.
Through-the-scope stent placement (feasibility): incidence of device related adverse device events at moment of stent placement
Device related adverse events are defined as all adverse events that take place during the through-the-scope stent placement. The incidence of the device related adverse events will be recorded.
Secondary Outcome Measures
Dysphagia, measured with the Ogilvie Dysphagia score (functional outcome)
Ogilvie dysphagia score measured at: baseline, 2 weeks and every 4 weeks until death/stent removal, or until a maximum of 6 months follow-up.
Retrosternal pain related to esophageal stent, measured with the Visual Analog Scale (functional outcome)
Retrosternal pain related to esophageal stent, measured with the Visual Analog Scale. Measurements will take place at 2 weeks and every 4 weeks until death/stent removal, or until a maximum of 6 months follow-up
Full Information
NCT ID
NCT03269903
First Posted
May 29, 2017
Last Updated
August 29, 2017
Sponsor
Radboud University Medical Center
Collaborators
Kebomed B.V.
1. Study Identification
Unique Protocol Identification Number
NCT03269903
Brief Title
TTS Esophageal HILZO Stent: A Safety and Feasibility Study
Acronym
HILZO
Official Title
TTS Esophageal HILZO Covered Self-expandable Metal Stent for Palliation of Malignant Dysphagia: A Safety and Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
March 1, 2018 (Anticipated)
Study Completion Date
September 1, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center
Collaborators
Kebomed B.V.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophagus Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Multicenter non-randomized prospective clinical study in 30 patients with malignant dysphagia
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients
Arm Type
Experimental
Arm Description
Patients with malignant dysphagia treated with the HILZO stent
Intervention Type
Device
Intervention Name(s)
HILZO esophageal stent
Intervention Description
A fully covered esophageal self-expandable metal stent for malignant dysphagia
Primary Outcome Measure Information:
Title
Incidence of treatment associated adverse events during follow-up (safety)
Description
Short term (within 7 days after treatment) and long term (after 7 days) 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.
Time Frame
1 year
Title
Through-the-scope stent placement (feasibility): (1) ease of deployment at intended esophageal location
Description
Technical success is defined as ease of through-the-scope deployment and placement of the stent at the required esophageal location.
Time Frame
1 day
Title
Through-the-scope stent placement (feasibility): incidence of device related adverse device events at moment of stent placement
Description
Device related adverse events are defined as all adverse events that take place during the through-the-scope stent placement. The incidence of the device related adverse events will be recorded.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Dysphagia, measured with the Ogilvie Dysphagia score (functional outcome)
Description
Ogilvie dysphagia score measured at: baseline, 2 weeks and every 4 weeks until death/stent removal, or until a maximum of 6 months follow-up.
Time Frame
6 months
Title
Retrosternal pain related to esophageal stent, measured with the Visual Analog Scale (functional outcome)
Description
Retrosternal pain related to esophageal stent, measured with the Visual Analog Scale. Measurements will take place at 2 weeks and every 4 weeks until death/stent removal, or until a maximum of 6 months follow-up
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bram Vermeulen, Drs.
Phone
0031611079557
Email
bram.vermeulen@radboudumc.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Siersema, professor
Organizational Affiliation
Radboud University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radboudumc
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6500HB
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bram Vermeulen, Drs.
Phone
0031611079557
Email
bram.vermeulen@radboudumc.nl
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31265819
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.
Results Reference
derived
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TTS Esophageal HILZO Stent: A Safety and Feasibility Study
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