Clinical trial · Interventional
Comparison of Efficacy Between a Newly Designed Covered Stent and Uncovered Stent for Malignant Colorectal Obstruction
Comparison of Efficacy Between a Newly Designed Covered Stent and Uncovered Stent for Malignant Colorectal Obstruction: a Prospective, Multicenter Study
- 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)
Acute colorectal obstruction has been reported to occur in 7 - 29% of all colorectal malignancies, but emergent surgical decompression is associated with high morbidity and mortality rates. Recently, self-expandable metal stents(SEMS) have been suggested as an alternative to surgery and effectively decompress the colonic obstruction and allow for bowel preparation and elective surgery. Theoretically, SEMSs are classified into uncovered stents and covered stents. Covered stents have the advantage of less frequent stent occlusion by tumor in-growth and the disadvantage of a high risk of stent migration, whereas uncovered stents are associated with less stent migration, although they appear to be more prone to tumor ingrowth. To overcome the drawbacks of conventional stents, a double-layered combination covered stent was developed. In the present study, the investigators evaluated the efficacy and safety of the newly designed covered stent by comparing it with the uncovered stent in patients with malignant colorectal obstruction.
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 |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| self-expandable metal stent insertion(covered stent) | Procedure | — | UNRESOLVED |
| self-expandable metal stent insertion(uncovered stent) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- covered stent
- description
- newly designed covered stent group
- interventionNames
- Procedure: self-expandable metal stent insertion(covered stent)
- type
- ACTIVE_COMPARATOR
- label
- uncovered stent
- description
- currently used uncovered stent group
- interventionNames
- Procedure: self-expandable metal stent insertion(uncovered stent)
Primary outcomes (1)
- measure
- Duration of stent patency between stent insertion and recurrence of obstructive symptoms
- timeFrame
- 2 years after the procedure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * 20\~85-year-old patients with malignant colorectal obstruction either by primary CRC or extracolonic malignancy * Patients with clinical obstructive symptoms confirmed by CT or colonoscopy Exclusion Criteria: * Patients with evidence of bowel perforation or peritonitis * Cause of obstruction other than malignancy (bowel adhesion or benign stricture) * Multiple stricture * Lower rectal cancer obstruction (AV \<5cm)
References
Publications (1)
- DERIVEDPark SJ, Park Y, Lee HJ, Park JJ, Cheon JH, Kim WH, Kim TI. Newly designed flared-end covered versus uncovered self-expandable metallic stents for palliation of malignant colorectal obstruction: a randomized, prospective study. Intest Res. 2025 Apr;23(2):202-212. doi: 10.5217/ir.2024.00135. Epub 2025 Feb 24. PMID 39988445