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

Etiology/histology stricture

Presence of distant metastasis

Previous chemotherapy

Previous radiotherapy

Location stricture

Length of tumor

Length of stricture

Dr. V.M.C.W. Spaander

Number of Participants With Recurrent Dysphagia.

Number of Participants With Technical Success of SEMS Placement

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

Number of Participants in Whom a Major Complication Has Occured

Median Survival After SEMS Placement

Overall Study

Biliary Tract Neoplasms

Biliary Tract Diseases

Deployment of Partially covered biliary self expandable metal stent

Deployment of Fully covered biliary self expandable metal stent

Used for palliation of inoperable malignant distal bile duct obstruction.

partially covered SEMS

fully covered SEMS

Jong Kyun Lee, M.D., Ph.D.

Jong-Kyun Lee, M.D., Ph.D.

The purpose of this study is to compare the duration of stent patency between partially covered and fully covered SEMS for palliation of malignant distal bile duct obstruction.

Endoscopic stent placement has been used as a principle palliative method in patients with unresectable distal malignancy biliary obstruction. It has been pivotal in providing relief from obstructive jaundice, improving the quality of life, and allowing the maintenance of chemotherapy. Although SEMSs have been reported to be superior to plastic stents in terms of stent patency, they still have some debatable issues ; in uncovered SEMS, stent occlusion due to epithelial hyperplasia and tumor ingrowth through the metal mesh is a frequent problem, whereas covered SEMSs are prone to migration.

The aim of the current study is to compare the duration of stent patency between partially covered and fully covered SEMS as a primary objective, and investigate overall patient survival, stent occlusion rate, and incidence of adverse events including stent dysfunction as secondary objectives.

Fully Covered SEMS Versus Partially Covered SEMS With Anti-migration System for Malignant Distal Biliary Obstruction

Comparison Between Fully Covered and Partially Covered Self-expandable Metal Stents With Anti-migration System for Malignant Distal Biliary Obstruction

Samsung Medical Center

Boston Scientific Wallflex Esophageal SEMS.

Erik Johnsson, MdPhd

Magnus Nilsson, ass professor

Self expandable stent (SEMS) constitutes the main palliative treatment in advanced esophageal cancer. The palliative effect of SEMS is immediate when it comes to relief of dysphagia. The duration of this effect is however questionable. The design of SEMS can be of importance since the device can dislodge and as a consequence of that dysphagia recur. The hypothesis has therefore been formulated that a partially covered SEMS is associated with less tendency to dislocate as compared to those SEMS, recently developed, which are covered through their entire length.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Fully Covered or Partially Covered Stents in Malignant Esophageal Strictures	NCT01661686	Esophageal Canc... Esophageal Sten...	Partially cover... Fully covered S...	18 Years -	Foundation for Liver Research
Fully Covered SEMS Versus Partially Covered SEMS With Anti-migration System for Malignant Distal Biliary Obstruction	NCT02255669	Biliary Tract N...	partially cover... fully covered S...	19 Years -	Samsung Medical Center
Treatment of Malignant Strictures in Esophagus and Gastroesophageal Junction With Covered or Partially Covered Stent.	NCT02166320	Esophageal Canc... Cancer of Gastr... Palliative Trea...	Partially cover... Fully covered S...	18 Years -	Karolinska University Hospital
Fully Covered or Partially Covered Stents in Malignant Esophageal Strictures	NCT01661686	Esophageal Canc... Esophageal Sten...	Partially cover... Fully covered S...	18 Years -	Foundation for Liver Research
Fully Covered SEMS Versus Partially Covered SEMS With Anti-migration System for Malignant Distal Biliary Obstruction	NCT02255669	Biliary Tract N...	partially cover... fully covered S...	19 Years -	Samsung Medical Center

Spots Global Cancer Trial Database for fully covered sems