TTS Esophageal HILZO Stent: A Safety and Feasibility Study

NCT ID: NCT03269903

Last Updated: 2017-09-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2018-09-01

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.

Conditions

Esophagus Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients

Patients with malignant dysphagia treated with the HILZO stent

Group Type: EXPERIMENTAL

HILZO esophageal stent

Intervention Type: DEVICE

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

Interventions

HILZO esophageal stent

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kebomed B.V.

UNKNOWN

Sponsor Role: collaborator

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Siersema, professor

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Locations

Radboudumc

Nijmegen, Gelderland, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Bram Vermeulen, Drs.

Role: CONTACT

bram.vermeulen@radboudumc.nl

0031611079557

Facility Contacts

Bram Vermeulen, Drs.

Role: primary

bram.vermeulen@radboudumc.nl

0031611079557

References

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.

Reference Type: DERIVED

PMID: 31265819 (View on PubMed)

Other Identifiers

NL.59951.091.16

Identifier Type: -

Identifier Source: org_study_id