Clinical trial NCT01661686: Fully Covered or Partially Covered Stents in Malignant Esophageal Strictures
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Esophageal Cancer
Esophageal Stenosis
Keywords: esophageal cancer
esophageal stenosis
stent
endoscopy
Lead sponsor: Foundation for Liver Research
Sponsor class: OTHER
First posted: 2012-08-09
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Recurrent Dysphagia.
timeFrame: From stent placement (t=0) until death or placement of second stent, assessed up to 6 months.
Secondary outcomes:
measure: Number of Participants With Technical Success of SEMS Placement
timeFrame: At stent placement (t=0)
measure: Number of Participants With Clinical Success Defined as Improvement of Dysphagia Score
timeFrame: From stent placement until death or placement of second stent, assessed up to 6 months.
measure: Number of Participants in Whom a Major Complication Has Occured
timeFrame: From stent placement until death or placement of second stent, assessed up to 6 months
measure: Median Survival After SEMS Placement
timeFrame: From stent placement until death or placement of second stent
Other outcomes:
Locations:
city: Capelle Aan Den IJssel
country: Netherlands
facility: IJsselland Hospital
state: Zuid Holland
city: Rotterdam
country: Netherlands
facility: Sint Fransiscus Gasthuis
state: Zuid Holland
city: Rotterdam
country: Netherlands
facility: Ikazia Hospital
state: Zuid Holland
city: Zwijndrecht
country: Netherlands
facility: Albert Schweitzer Hospital
state: Zuid Holland
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
Study officials:
affiliation: Erasmus Medical Center
name: Marco J Bruno, M.D., Prof
role: STUDY_DIRECTOR
References:
citation: Didden P, Reijm AN, Erler NS, Wolters LMM, Tang TJ, Ter Borg PCJ, Leeuwenburgh I, Bruno MJ, Spaander MCW. Fully vs. partially covered selfexpandable metal stent for palliation of malignant esophageal strictures: a randomized trial (the COPAC study). Endoscopy. 2018 Oct;50(10):961-971. doi: 10.1055/a-0620-8135. Epub 2018 Jun 12.