Neoplasms

Digestive System Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Esophageal Neoplasms

Constriction, Pathologic

Esophageal Stenosis

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

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

Partially covered SEMS

Fully covered SEMS

Marco J Bruno, M.D., Prof

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

Fully Covered or Partially Covered Stents in Malignant Esophageal Strictures

A Randomized Comparison of a Fully Covered Self Expandable Metal Stent Versus a Partially Covered Self Expandable Metal Stent in Malignant Esophageal Strictures

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.

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

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

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.

Survival from stent placement until death or placement of second stent

Foundation for Liver Research

M.D., PhD

One patient, which was allocated to a FC SEMS, was excluded for analysis. In this patient the SEMS could not be inserted due to an acute cardiovascular event at the start of the endoscopic procedure. A total of 97 patients were included for final analysis, 48 patients in FC SEMS and 49 patients in the PC group.

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

Insertion of a Partially Covered SEMS

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

Insertion of a Fully Covered SEMS

Total

Age, Continuous

Sex: Female, Male

Dysphagia was scored according to the internationally used scoring system: score 0, able to consume a normal diet; score 1, dysphagia with certain solid foods; score 2, able to swallow semi-solid soft foods; score 3, able to swallow liquids only; score 4, complete dysphagia.

Range 0-4, a higher score represents a worse outcome

Dysphagia score

World Health Organization Performance Score

0 Able to carry out all normal activity without restrictions.

1. Restricted in physically strenuous activity but ambulatory and able to carry out light work.
2. Ambulatory and capable of all self-care but unable to carry out any work; up and more than 50% of waking hours.
3. Capable of only limited self-care; confined to bed or chair more than 50% of waking hours.
4. Completely disabled; cannot carry on any self-care; totally confined to bed or chair.

Range 0-4, a higher score respresents a worse outcome

Spots Global Cancer Trial Database for Fully Covered or Partially Covered Stents in Malignant Esophageal Strictures

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Study Description

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