Esophageal HILZO Covered self-expandable metal stent for palliation of malignant dysphagia: A Safety and Feasibility Study

Phase 4

Completed

Conditions: esophageal cancer
esophageal carcinoma
10018008

Registration Number: NL-OMON45573

Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

• Non-operable malignant obstruction of the esophagus or esophagogastric junction, extrinsic malignant compression, or recurrent malignant dysphagia after esophagectomy. A tumor is considered inoperable if the patient has local tumor infiltration in the surrounding organs, distant metastases or a poor general health due to serious concomitant disease.
OR
• Recurrent dysphagia after prior radiation with curative or palliative intent for esophageal or gastric cardia cancer.
• Requiring treatment for dysphagia (dysphagia score of 2-4, according to Ogilvie2)
• Written informed consent
• Age >= 18 years

Exclusion Criteria

• Inappropriate cultural level and understanding of the study.
• Simultaneous participation in another clinical study
• Life expectancy of less than 12 months
• Stenosis after laryngectomy, or if the distance between the upper edge of the stent is less than 2 cm from the upper esophageal sphincter
• Tumor length of more than 12cm
• Coagulopathy
• Previous stent placement for the same condition

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The evaluation of all study participants will be registered by the principal<br /><br>investigator.<br /><br>The primary objective will be the safety and efficacy of esophageal HILZO<br /><br>Covered stent.<br /><br><br /><br>1. Safety: complications during the follow-up period until death will be<br /><br>registered and evaluated (migration, food impaction, bleeding, esophageal<br /><br>perforation, etc.).<br /><br>2. Efficacy: technical successful TTS placement of the esophageal HILZO Covered<br /><br>stent, correct positioning at the stenosis under endoscopic guidance.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Long-term efficacy (dysphagia) will be measured at baseline and during<br /><br>follow-up until death with the Ogilvie dysphagia score.<br /><br>2. Pain during follow-up: the first two weeks pain will be measured daily with<br /><br>a patient diary, using the Visual Analogue Scale (VAS). After this, pain will<br /><br>be assessed with the VAS during follow-up.<br /><br>3. The presence of hyperplastic reaction will be objectified if appropriate<br /><br>during endoscopic controls according to standard care.</p><br>