Clinical trial · Interventional
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
NCT01661686CI-TRIAL-00040984COPACcompletedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Esophageal Stenosis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fully covered SEMS | Device | — | UNRESOLVED |
| Partially covered SEMS | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Insertion of a partially covered SEMS
- interventionNames
- Device: Partially covered SEMS
- type
- ACTIVE_COMPARATOR
- label
- Insertion of a Fully covered SEMS
- interventionNames
- Device: Fully covered SEMS
Primary outcomes (1)
- 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.
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDDidden 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. PMID 29895072