Clinical trial · Interventional
Prospective Comparison of Large vs. Small Diameter Esophageal Stents for Palliation of Malignant Dysphagia
Randomized, Prospective Comparison of Large vs. Small Diameter Esophageal Stents for Palliation of Malignant Dysphagia
- 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)
Esophageal cancer often causes difficulty swallowing (dysphagia) that can be relieved by placement of a stent (a flexible, expandable tube that props open the blockage caused by the cancer). Stents are effective but can cause complications. Stents come in different diameters. The purpose of this study is to learn if stents of different diameters are more or less effective for treatment of dysphagia caused by esophageal cancer.
Conditions
Conditions (1)
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 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Self-expandable metal stent | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Small-diameter stent
- description
- Placement of a 23 mm self-expandable metal stent
- interventionNames
- Device: Self-expandable metal stent
- type
- ACTIVE_COMPARATOR
- label
- Large-diameter stent
- description
- Placement of a 28-mm self-expandable metal stent
- interventionNames
- Device: Self-expandable metal stent
Primary outcomes (3)
- measure
- Relief of dysphagia
- timeFrame
- 1 month following stent placement
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * age ≥ 18 years * dysphagia due to unresectable esophageal cancer * participant resides within 50 km of Tenwek Hospital * tumor is ≤ 9 cm in length and \> 2 cm distal to the upper esophageal sphincter (UES) * no esophago-respiratory fistula (ERF) or suspected perforation is present Exclusion Criteria: * unable to provide written informed consent
References
Publications (1)
- DERIVEDWhite RE, Chepkwony R, Mwachiro M, Burgert SL, Enders FT, Topazian M. Randomized Trial of Small-diameter Versus Large-diameter Esophageal Stents for Palliation of Malignant Esophageal Obstruction. J Clin Gastroenterol. 2015 Sep;49(8):660-5. doi: 10.1097/MCG.0000000000000333. PMID 25992812