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

Oesophageal Cancer Clinical Trial

— ENTRANCE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06364553
• Other study ID #: NL86416.078.24
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: May 1, 2025

Study information

• Verified date: June 2024
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: May 1, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Oesophageal Cancer

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Erasmus Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient characteristic: age	Patient age at baseline, so at the day of stent placement, measured in years	1 day, at stent placement
Other	Patient characteristic: gender	Patient gender at baseline, at the day of stent placement, measured as male or female	1 day, at stent placement
Other	Patient characteristic: tumor location	Location of the tumor in the esophagus, measured in cm from incisors during stent placement	1 day, during stent placement
Other	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
Other	Stent characteristic: length of the stent	Length of the stent, determined during stent placement in millimeters	1 day, during stent placement
Other	Stent characteristic: diameter of the stent	Diameter of the stent, determined during stent placement in millimeters	1 day, during stent placement
Other	Patient characteristic: prior radiotherapy	Determining whether patient received radiotherapy prior to the stent placement, described as yes or no	1 day, before stent placement
Other	Patient characteristic: prior chemotherapy	Determining whether patient received chemotherapy prior to the stent placement, described as yes or no	1 day, before stent placement
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	Overall survival	Overall survival measured in days	6 months