TTS Esophageal HILZO Stent: A Safety and Feasibility Study

Esophagus Cancer Clinical Trial

— HILZO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03269903
• Other study ID #: NL.59951.091.16
• Status: Recruiting
• Phase: N/A
• First received: May 29, 2017
• Last updated: August 29, 2017
• Start date: March 1, 2017
• Est. completion date: September 1, 2018

Study information

• Verified date: May 2017
• Source: Radboud University
• Contact: Bram Vermeulen, Drs.
• Phone: 0031611079557
• Email: bram.vermeulen[@]radboudumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 1, 2018
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Neoplasms
• Esophagus Cancer

Intervention

Device:
• HILZO esophageal stent
A fully covered esophageal self-expandable metal stent for malignant dysphagia

Locations

Country	Name	City	State
Netherlands	Radboudumc	Nijmegen	Gelderland

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University	Kebomed B.V.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year
Primary	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.	1 day
Primary	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.	1 day
Secondary	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.	6 months
Secondary	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	6 months