Clinical trial · Interventional
Migration Rates of Sutured vs Non-sutured Esophageal Stent Placement
- 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)
No standard approach currently exists for endoscopic esophageal stent placement, and both sutured and un-sutured techniques are employed for esophageal stent placement currently. The primary purpose of this study is to find out if suture fixation of esophageal stents is superior to non-suture fixated stent placement. Consecutive patients who are scheduled for esophageal stent placement will be identified as potential study participants by study personnel and will be approached on the day of the procedure. Informed consent will be obtained and patients will be randomized into suture fixation and non-suture fixation groups. Patients in the suture fixation group will have their esophageal stent secured in location with two endoscopic sutures. Those in the non-suture fixation group will have no sutures placed. Main study outcome is stent migration, and rates of stent migration will be compared in the two groups.
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 |
|---|---|---|---|
| Dysphagia, Esophageal | — | UNRESOLVED | — |
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Non suture | Other | — | UNRESOLVED |
| Suture fixation of stent | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Suture arm
- description
- Esophageal stent will be placed in standard of care fashion by the endoscopists using standard gastroscopes. After esophageal stent placement, endoscopic suturing will be performed in cases of patients randomized to suture fixation.
- interventionNames
- Other: Suture fixation of stent
- type
- PLACEBO_COMPARATOR
- label
- Non-suture
- description
- Esophageal stent will be placed in standard of care fashion by the endoscopists using standard gastroscopes. No sutures will be placed to fixate the stent
- interventionNames
- Other: Non suture
Primary outcomes (1)
- measure
- Composite of stent migration or total stent dislodgement
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * Able to provide informed consent * Indication for esophageal stent placement Exclusion Criteria: * Presence of any contraindication to esophageal stent placement * Incarceration * Inability to tolerate anesthesia * Pregnant status
References
Publications (1)
- DERIVEDSingh S, Maan S, Hadi Y, Agrawal R, Adekolu AA, Cohen EM, Ali FS, Fang W, Markovich B, Krafft M, Thakkar S. Endoscopic suturing to prevent migration of esophageal fully covered self-expandable metal stents: a randomized controlled trial (with video). Gastrointest Endosc. 2025 Oct;102(4):525-535.e4. doi: 10.1016/j.gie.2025.02.037. Epub 2025 Feb 28. PMID 40024292