Fully Covered or Partially Covered Stents in Malignant Esophageal Strictures

Esophageal Cancer Clinical Trial

— COPAC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01661686
• Other study ID #: COPAC
• Status: Completed
• Phase: N/A
• Start date: July 2012
• Est. completion date: October 2016

Study information

• Verified date: September 2019
• Source: Foundation for Liver Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: October 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms
• Esophageal Stenosis

Intervention

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

Locations

Country	Name	City	State
Netherlands	IJsselland Hospital	Capelle Aan Den IJssel	Zuid Holland
Netherlands	Erasmus Medical Center	Rotterdam
Netherlands	Ikazia Hospital	Rotterdam	Zuid Holland
Netherlands	Sint Fransiscus Gasthuis	Rotterdam	Zuid Holland
Netherlands	Albert Schweitzer Hospital	Zwijndrecht	Zuid Holland

Sponsors (1)

Lead Sponsor	Collaborator
Foundation for Liver Research

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From stent placement (t=0) until death or placement of second stent, assessed up to 6 months.
Secondary	Number of Participants With Technical Success of SEMS Placement	Technical succes was defined as succesful deployment of the stent which bridges the stricture	At stent placement (t=0)
Secondary	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	From stent placement until death or placement of second stent, assessed up to 6 months.
Secondary	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.	From stent placement until death or placement of second stent, assessed up to 6 months
Secondary	Median Survival After SEMS Placement	Survival from stent placement until death or placement of second stent	From stent placement until death or placement of second stent