TTS Esophageal HILZO Stent: A Safety and Feasibility Study (HILZO)

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

Study Overview

• Status: Unknown
• Conditions: Esophagus Cancer
• Intervention / Treatment: Device: HILZO esophageal stent

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bram Vermeulen, Drs.; Phone Number: 0031611079557; Email: bram.vermeulen@radboudumc.nl

Study Locations

• Netherlands
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6500HB
      • Recruiting
      • Radboudumc
      • Contact: Bram Vermeulen, Drs.; Phone Number: 0031611079557; Email: bram.vermeulen@radboudumc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Patients; Patients with malignant dysphagia treated with the HILZO stent	Device: HILZO esophageal stent; A fully covered esophageal self-expandable metal stent for malignant dysphagia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Collaborators: Kebomed B.V.
• Investigators: Principal Investigator: Peter Siersema, professor, Radboud university medical center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2017
• Primary Completion (ANTICIPATED): March 1, 2018
• Study Completion (ANTICIPATED): September 1, 2018

Study Registration Dates

• First Submitted: May 29, 2017
• First Submitted That Met QC Criteria: August 29, 2017
• First Posted (ACTUAL): September 1, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 1, 2017
• Last Update Submitted That Met QC Criteria: August 29, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms
• Other Study ID Numbers: NL.59951.091.16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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