Esophageal Multisegmented FCSEMS for Malignant Strictures

NCT ID: NCT04415463

Last Updated: 2023-01-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-03
• Study Completion Date: 2022-12-01

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.

Conditions

Oesophageal Cancer; Esophageal Stent Stenosis

Study Design

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

Study Groups

FC-SEMS

Placement of multisegmented fully covered self-expandable metal stent

Group Type: EXPERIMENTAL

Multisegmented fully covered self-expandable metal stent

Intervention Type: DEVICE

Esophageal FC-SEMS

Interventions

Multisegmented fully covered self-expandable metal stent

Esophageal FC-SEMS

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

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

Sponsors

Erasmus Medical Center

OTHER

Sponsor Role: collaborator

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Radboudumc

Nijmegen, Gelderland, Netherlands

Countries

Netherlands

References

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.

Reference Type: DERIVED

PMID: 38316224 (View on PubMed)

Other Identifiers

NL73180.091.20

Identifier Type: -

Identifier Source: org_study_id