NCT04415463

Brief Summary

Objective: To assess the safety and feasibility of the implementation of the esophageal multisegmented fully covered self-expandable metal stent (SEMS) for the palliation of patients with malignant dysphagia. Study design: Prospective observational nonrandomized clinical study. Study population: A total of 30 patients with malignant dysphagia will be included. Sample size calculation does not apply for this type of study. Intervention: All patients will be treated with the esophageal multisegmented fully covered SEMS. Primary end points:

  • Safety: complications and adverse events during follow-up with special attention to stent migration rates;
  • Efficacy: technical success of stent placement. Secondary end points:
  • Recurrent dysphagia including its cause;
  • Functional outcome: Ogilvie dysphagia score and WHO performance score (measured at baseline, 2 weeks and every 4 weeks until death/stent removal, or until a maximum of 6 months follow-up);
  • Tissue ingrowth or overgrowth (measured endoscopically every endoscopic evaluation during follow-up);
  • Pain related to esophageal stent.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 4, 2020

Completed
9 months until next milestone

Study Start

First participant enrolled

March 3, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

January 12, 2023

Status Verified

January 1, 2023

Enrollment Period

1.7 years

First QC Date

May 25, 2020

Last Update Submit

January 10, 2023

Conditions

Oesophageal CancerEsophageal Stent Stenosis

Outcome Measures

Primary Outcomes (2)

  • Adverse events

    Adverse events during follow-up

    6 months

  • Technical success of stent placement

    Technical success of stent placement

    1 day

Secondary Outcomes (4)

  • Recurrent dysphagia

    6 months

  • Functional outcome

    6 months

  • Tissue ingrowth or overgrowth

    6 months

  • Pain related to esophageal stent

    6 months

Study Arms (1)

FC-SEMS

EXPERIMENTAL

Placement of multisegmented fully covered self-expandable metal stent

Device: Multisegmented fully covered self-expandable metal stent

Interventions

Multisegmented fully covered self-expandable metal stentDEVICE

Esophageal FC-SEMS

FC-SEMS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients presenting with dysphagia due to a non-operable malignant obstruction of the esophagus or esophagogastric junction including extrinsic malignant compression and recurrence in post-esophagectomy patients;
  • Requiring treatment for dysphagia (Ogilvie score of 2-41);
  • Life expectancy of less than 12 months.

You may not qualify if:

  • Stenosis after laryngectomy;
  • Distance between the upper edge of the stent less than 2 cm from the upper esophageal sphincter;
  • Esophageal fistula;
  • Tumor length of more than 14 cm;
  • Previous stent placement for the same condition;
  • Inappropriate cultural level and understanding of the study;
  • Coagulopathy;
  • Patients with eosinophilic esophagitis or an esophageal motility disorder;
  • Nickel titanium (Nitinol) allergy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboudumc

Nijmegen, Gelderland, 6500, Netherlands

Location

Related Publications (1)

  • Koggel LM, Reijm AN, Lantinga MA, de Jong DJ, Rodrigues-Pinto E, Spaander MCW, Siersema PD. Multisegmented esophageal fully covered self-expandable metal stent for palliation of malignant dysphagia: a prospective, multicenter feasibility and safety study. Gastrointest Endosc. 2024 Jun;99(6):1027-1031.e6. doi: 10.1016/j.gie.2024.01.045. Epub 2024 Feb 3.

    PMID: 38316224DERIVED

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Study Design

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

Study Record Dates

First Submitted

May 25, 2020

First Posted

June 4, 2020

Study Start

March 3, 2021

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

January 12, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)