Esophageal Self-expandable Metal Stent for Malignant Strictures: a Safety and Efficacy Study

NCT06364553 | Recruiting DMC

• 1 other identifier: NL86416.078.24
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

A single center prospective observational non-randomized clinical study to assess the safety and efficacy of placement of a new esophageal self-expandable metal stent (SEMS) for palliation of patients with malignant dysphagia.

Conditions

Oesophageal Cancer

Outcome Measures

Primary Outcomes (7)

• Complication: incidence of perforation

  The complication perforation during stent placement and during follow-up will be measured using patient anamneses and if necessary upper endoscopy and described as present yes or no. After all patients are included, the incidence can be described as percentage.

  6 months

• Complication: incidence of hemorrhage

  The complication hemorrhage will be measured during stent placement and follow-up using patient anamneses and if necessary with an upper endoscopy and described as present yes or no. After all patients are included, the incidence can be described as percentage.

  6 months

• Complication: incidence of fistula formation

  The complication fistula formation will be measured during stent placement and during follow-up using patient anamneses and if necessary with an upper endoscopy and is described as present yes or no. After all patients are included, the incidence can be described as percentage.

  6 months

• Complication: incidence of gastroesophageal reflux

  The complication gastroesophagel reflux will be measured after stent placement with the use of patient anamneses and will be described as present yes or no. After all patients are included, the incidence can be described as percentage.

  6 months

• Complication: incidence of stent migration

  The complication stent migration will be measured using a new upper endoscopy in case there is recurrent dysphagia (measured with the Ogilvie Dysphagia score from 0 = no dysphagia to 4 = inability to swallow food or liquids, so the higher te score, the worse the outcome) and described as present yes or no. After all patients are included, the incidence can be described as percentage.

  6 months

• Efficacy: clinical outcome

  The clinical outcome will be measured using the Ogilvie Dysphagia Score to determine whether recurrent dysphagia is present after stent placement during follow-up or until death. The Ogilvie Dysphagia Score is a score ranging from 0 = no dysphagia to 4 = inability to swallow any food or liquids, so the higher te score, the worse the outcome.

  6 months

• Efficacy: incidence of patients receiving technical successful stent placement

  Technical successful stent placement will be measured during stent placement whether the stent is in the correct position (covering the whole stenosis) and is described as yes or no. After all patients are included, the incidence can be described as percentage.

  1 day, during stent placement

Secondary Outcomes (3)

• Incidence of recurrent dysphagia

  6 months

• Pain related to esophageal stent (placement)

  6 months

• Overall survival

  6 months

Other Outcomes (8)

• Patient characteristic: age

  1 day, at stent placement

• Patient characteristic: gender

  1 day, at stent placement

• Patient characteristic: tumor location

  1 day, during stent placement

Study Arms (1)

Esophageal self-expandable metal stent

OTHER

Esophageal self-expandable metal stent

Device: Esophageal self-expandable metal stent

Interventions

Esophageal self-expandable metal stent DEVICE

The Leufen Esophageal aixstent ® (Leufen Medical GmbH) is indicated for the treatment of malignant esophageal strictures and postoperative stenosis. It is comprised of two components: an implantable metallic stent and the delivery system. After the procedure, the stent remains at the intended location, within the patient while the delivery system is removed.

Esophageal self-expandable metal stent

Eligibility Criteria

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

You may qualify if:

• Patients presenting with dysphagia due to a non-curable 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;
• Written informed consent;
• Age ≥ 18 years.

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;
• Tumor length of more than 14 cm;
• Previous stent placement for the same condition;
• Coagulopathy (not corrected prior to stent placement);
• Patients with eosinophilic esophagitis or an esophageal motility disorder;
• Nickel titanium (Nitinol) allergy.

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Erasmus MC

Rotterdam, South Holland, 3015GD, Netherlands

RECRUITING

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

Central Study Contacts

Annemijn D I Maan

CONTACT

+31653305615; a.maan@erasmusmc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr.

Study Record Dates

• First Submitted: April 3, 2024
• First Posted: April 15, 2024
• Study Start: October 2, 2024
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: August 7, 2025

Record last verified: 2025-08

Locations

NL (1)