N/A
N=98
Fully Covered or Partially Covered Stents in Malignant Esophageal Strictures
Esophageal Cancer · Esophageal Stenosis
Bottom Line
View on ClinicalTrials.gov: NCT01661686 ↗Enrolled (actual)
98
Serious AEs
42.3%
Results posted
Oct 2019
Primary outcome: Primary: Number of Participants With Recurrent Dysphagia. — 11; 9 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Partially covered SEMS (Device); Fully covered SEMS (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Foundation for Liver Research
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Recurrent Dysphagia. |
11; 9 | — |
| SECONDARY Number of Participants With Technical Success of SEMS Placement |
47; 48 | — |
| SECONDARY Number of Participants With Clinical Success Defined as Improvement of Dysphagia Score |
43; 40 | — |
| SECONDARY Number of Participants in Whom a Major Complication Has Occured |
23; 18 | — |
| SECONDARY Median Survival After SEMS Placement |
92; 61 | — |
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
Data sourced from ClinicalTrials.gov (NCT01661686). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.