TTS Esophageal HILZO Stent: A Safety and Feasibility Study

NCT03269903 | Unknown

• 1 other identifier: NL.59951.091.16
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Esophagus Cancer

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Dysphagia, measured with the Ogilvie Dysphagia score (functional outcome)

  6 months

• Retrosternal pain related to esophageal stent, measured with the Visual Analog Scale (functional outcome)

  6 months

Study Arms (1)

Patients

EXPERIMENTAL

Patients with malignant dysphagia treated with the HILZO stent

Device: HILZO esophageal stent

Interventions

HILZO esophageal stent DEVICE

A fully covered esophageal self-expandable metal stent for malignant dysphagia

Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Kebomed B.V.: collaborator

Study Sites (1)

Radboudumc

Nijmegen, Gelderland, 6500HB, Netherlands

RECRUITING

Related Publications (1)

• 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.

  PMID: 31265819 DERIVED

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Peter Siersema, professor

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bram Vermeulen, Drs.

CONTACT

0031611079557; bram.vermeulen@radboudumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicenter non-randomized prospective clinical study in 30 patients with malignant dysphagia

Study Record Dates

• First Submitted: May 29, 2017
• First Posted: September 1, 2017
• Study Start: March 1, 2017
• Primary Completion: March 1, 2018
• Study Completion: September 1, 2018
• Last Updated: September 1, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)