Fully Covered or Partially Covered Stents in Malignant Esophageal Strictures

Not Applicable

Completed

• Conditions: Esophageal Cancer; Esophageal Stenosis
• Interventions: Device: Partially covered SEMS; Device: Fully covered SEMS

• Registration Number: NCT01661686
• Lead Sponsor: Foundation for Liver Research

Brief Summary

The purpose of this study is to determine whether fully covered or partially covered metal stents are more favorable in incurable malignant stenosis of the esophagus or cardia. Primary outcome will be the occurence of recurrent dysphagia which is defined as dysphagia due to a stent or tumour related cause in a 6-month follow-up

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-08-01
• Study First Submitted QC: 2012-08-06
• Study First Posted: 2012-08-09
• Primary Completion: 2016-04
• Study Completion: 2016-10
• Results First Submitted: 2019-01-11
• Status Verified: 2019-09
• Results First Submitted QC: 2019-09-09
• Last Update Submitted: 2019-09-09
• Results First Posted: 2019-10-03
• Last Update Posted: 2019-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

• Malignant stricture of the esophagus or cardia
• No curative treatment options available
• Dysphagia grade of at least 2 (i.e. swallow semi-solid foods or less)
• Informed consent
• Age ≥ 18 years

Exclusion Criteria

• Previous treatment with self-expandable metal stent for same condition
• Evidence of tumor within 2 cm of the upper esophageal sphincter.
• Presence of an esophago-tracheal or -bronchial fistula or both.
• Not able to undergo upper endoscopy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Insertion of a partially covered SEMS	Partially covered SEMS	-
Insertion of a Fully covered SEMS	Fully covered SEMS	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Recurrent Dysphagia.	From stent placement (t=0) until death or placement of second stent, assessed up to 6 months.	This is defined as occurrence of dysphagia due to a stent or tumor related cause. These include tumor in- or overgrowth, stent migration, stent fracture or food impaction.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Technical Success of SEMS Placement	At stent placement (t=0)	Technical succes was defined as succesful deployment of the stent which bridges the stricture
Number of Participants With Clinical Success Defined as Improvement of Dysphagia Score	From stent placement until death or placement of second stent, assessed up to 6 months.	Clinical success was defined as an improvement of dysphagia (at least 1 point reduction in the Dysphagia score) during follow-up.; Dysphagia scores will be obtained at time point: t=0, t= 1 week, t=2 weeks, t=1 month, t=3 months and t= 6 months
Number of Participants in Whom a Major Complication Has Occured	From stent placement until death or placement of second stent, assessed up to 6 months	A major adverse event was defined as a life-threatening event, including perforation, major haemorrhage, severe pain (NRS pain score ≥ 7), pneumonia, stridor and fistula.
Median Survival After SEMS Placement	From stent placement until death or placement of second stent	Survival from stent placement until death or placement of second stent

Trial Locations

Locations (5)

Albert Schweitzer Hospital; 🇳🇱 Zwijndrecht, Zuid Holland, Netherlands

IJsselland Hospital; 🇳🇱 Capelle Aan Den IJssel, Zuid Holland, Netherlands

Erasmus Medical Center; 🇳🇱 Rotterdam, Netherlands

Sint Fransiscus Gasthuis; 🇳🇱 Rotterdam, Zuid Holland, Netherlands

Ikazia Hospital; 🇳🇱 Rotterdam, Zuid Holland, Netherlands