Fully Covered or Partially Covered Stents in Malignant Esophageal Strictures

Foundation for Liver Research98 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Esophageal Cancer Esophageal Stenosis

Interventions

Partially covered SEMSDEVICE

Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available

Fully covered SEMSDEVICE

Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (5)

IJsselland Hospital

Capelle aan den IJssel, South Holland, Netherlands

Sint Fransiscus Gasthuis

Rotterdam, South Holland, Netherlands

Ikazia Hospital

Rotterdam, South Holland, Netherlands

Albert Schweitzer Hospital

Zwijndrecht, South Holland, Netherlands

Outcomes

Primary Outcomes

Number of Participants With Recurrent Dysphagia.

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.

Time frame: From stent placement (t=0) until death or placement of second stent, assessed up to 6 months.

Secondary Outcomes

Number of Participants With Technical Success of SEMS Placement

Technical succes was defined as succesful deployment of the stent which bridges the stricture

Time frame: At stent placement (t=0)

Number of Participants With Clinical Success Defined as Improvement of Dysphagia Score

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

Time frame: From stent placement until death or placement of second stent, assessed up to 6 months.

Number of Participants in Whom a Major Complication Has Occured

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.

Time frame: From stent placement until death or placement of second stent, assessed up to 6 months

Median Survival After SEMS Placement

Survival from stent placement until death or placement of second stent

Time frame: From stent placement until death or placement of second stent

Data from ClinicalTrials.gov

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