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Completed

NCT Number: NCT01661686

Fully Covered or Partially Covered Stents in Malignant Esophageal Strictures

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

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Key information

Conditions

Esophageal Cancer Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Esophageal Stenosis Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IJsselland Hospital, Capelle aan den IJssel, South Holland, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Partially covered SEMS

Device

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

Other names: WallFlex Partially covered esophageal stent

Fully covered SEMS

Device

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

Other names: WallFlex Fully covered esophageal stent

Primary outcomes

  1. Number of Participants With Recurrent Dysphagia.

    Time frame: 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 outcomes

  1. Number of Participants With Technical Success of SEMS Placement

    Time frame: At stent placement (t=0)

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

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

    Time frame: 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

  3. Number of Participants in Whom a Major Complication Has Occured

    Time frame: 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.

  4. Median Survival After SEMS Placement

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

    Survival from stent placement until death or placement of second stent

Sponsors and collaborators

Lead sponsor

Foundation for Liver Research

Other

Registry information

Official study title

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

Acronym: COPAC

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Aug 9, 2012
Registry last updated
Oct 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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