Clinical trial · Interventional
Fully Coated, Removable, Self-expanding Oesophageal Stents for Preventing Strictures Following Complete Barretts Excision.
Fully, Coated, Removable, Self-expanding Oesophageal Stents for the Prevention of Oesophageal Stricture Following Endoscopic Mucosal Resection of Short Segment Barrett's With High Grade Dysplasia and Early Cancer.
- 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 investigate whether preventative placement of a removable oesophageal stent reduces the rate of scar tissue, or stricture formation after removing the precancerous or early cancerous Barrett's mucosa by Endoscopic Mucosal Resection (EMR). The stent will be placed 10-14 days after initial EMR. The stent will then be removed 8 weeks later by repeat Endoscopy. Patients will be followed up weekly following insertion of the oesophageal stent.
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 |
|---|---|---|---|
| Constriction, Pathological | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fully coated, removable , self-expanding oesophageal stent | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Oesophageal Stents
- description
- Patients enrolled will receive a fully coated, removable, self-expanding oesophageal stent.
- interventionNames
- Device: Fully coated, removable , self-expanding oesophageal stent
Primary outcomes (1)
- measure
- Improvement in Stricture Formation
- timeFrame
- 12 weeks
- description
- Initial evaluation of Dysphagia score which is used to assess the stricture formation prior to EMR. Followed by weekly phone calls to assess ability to swallow liquids and food.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with short segment Barrett's Oesophagus with high grade dysplasia or early cancer, having circumferential EMR to achieve complete Barrett's excision. * Aged 18-75 years old * Biopsy proven to be Barretts with HGD or EAC * The absence or lymph node involvement * Short segment \<3cm of Barretts Oesophagus. Exclusion Criteria: * Women who are pregnant and the human foetus * Children and/or young people \<18 years * People with an intellectual or mental impairment.
References
Publications (1)
- DERIVEDHolt BA, Jayasekeran V, Williams SJ, Lee EY, Bahin FF, Sonson R, Lord RV, Bourke MJ. Early metal stent insertion fails to prevent stricturing after single-stage complete Barrett's excision for high-grade dysplasia and early cancer. Gastrointest Endosc. 2015 Apr;81(4):857-64. doi: 10.1016/j.gie.2014.08.022. Epub 2014 Oct 16. PMID 25442084