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

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.

Study Overview

• Status: Recruiting
• Conditions: Oesophageal Cancer
• Intervention / Treatment: Device: Esophageal self-expandable metal stent

Detailed Description

Objective: To assess the safety and efficacy of placement of a new esophageal self-expandable metal stent (SEMS) for palliation of patients with malignant dysphagia.

Study design: Single center prospective observational non-randomized clinical study.

Study population: A total of 20 patients with malignant dysphagia will be included. Sample size calculation does not apply for this type of study. Outcome of the study (efficacy and safety) will be compared to our historic esophageal stent database, including over 1000 patients.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Annemijn D I Maan; Phone Number: +31653305615; Email: a.maan@erasmusmc.nl

Study Locations

• Netherlands
  • Zuid-Holland
    • Rotterdam, Zuid-Holland, Netherlands, 3015GD
      • Recruiting
      • Erasmus MC
      • Contact: Annemijn Maan, MD; Phone Number: +31650033984; Email: a.maan@erasmusmc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Esophageal self-expandable metal stent

Device: Esophageal self-expandable metal stent; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of recurrent dysphagia	Recurrent dysphagia will be asked from the patient and will be measured with the Ogilvie Dysphagia score (ranging from 0 = no dysphagia to 4 = inability to swallow any food or liquids, so the higher te score, the worse the outcome). After all patients are included, the incidence can be described as percentage.	6 months
Pain related to esophageal stent (placement)	Pain related to esophageal stent (placement) measured daily using a patient diary which scores the Visual Analogue Scale (ranging from 0 = no pain to 10 = the worst pain imaginable, so the higher the score, the worse the outcome) during the first two weeks, after this every 4 weeks a telephone call with the patient will be held to discuss pain using the Visual Analogue Scale as well until death/stent removal, or until a maximum of 6 months follow-up)	6 months
Overall survival	Overall survival measured in days	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient characteristic: age	Patient age at baseline, so at the day of stent placement, measured in years	1 day, at stent placement
Patient characteristic: gender	Patient gender at baseline, at the day of stent placement, measured as male or female	1 day, at stent placement
Patient characteristic: tumor location	Location of the tumor in the esophagus, measured in cm from incisors during stent placement	1 day, during stent placement
Patient characteristic: tumor histology	Histology of the tumor in the esophagus, measured from biopsy results from upper endoscopies perfomed prior to the stent placement	1 day, checking PA records
Stent characteristic: length of the stent	Length of the stent, determined during stent placement in millimeters	1 day, during stent placement
Stent characteristic: diameter of the stent	Diameter of the stent, determined during stent placement in millimeters	1 day, during stent placement
Patient characteristic: prior radiotherapy	Determining whether patient received radiotherapy prior to the stent placement, described as yes or no	1 day, before stent placement
Patient characteristic: prior chemotherapy	Determining whether patient received chemotherapy prior to the stent placement, described as yes or no	1 day, before stent placement

Collaborators and Investigators

• Sponsor: Erasmus Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2024
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: April 3, 2024
• First Submitted That Met QC Criteria: April 9, 2024
• First Posted (Actual): April 15, 2024

Study Record Updates

• Last Update Posted (Actual): August 7, 2025
• Last Update Submitted That Met QC Criteria: August 4, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: NL86416.078.24

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No