Clinical trial · Interventional
Self-expandable Metal Stent (SEMS) Endoscopic Placement for Malignant Colonic Obstruction Therapy
Randomized Non-inferiority Single-center Prospective Trial of Malignant Colonic Obstruction Therapy With Self-expandable Metal Stent (SEMS) Endoscopic Placement or Stoma Formation.
NCT05643989CI-TRIAL-00062612PATENCYunknownN/AClinicalTrials.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)
Compare the effectiveness of Self-expandable metal stent (SEMS) and diverting stoma formation for the bowel preparation as a bridge to surgical treatment of patients with MCO.
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 |
|---|---|---|---|
| Neoplasms,Colorectal | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endoscopic self-expandable metal stent placement | Procedure | — | UNRESOLVED |
| Stoma formation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Self-expandable metal stent (SEMS) endoscopic placement.
- description
- Anesthesia will include only propofol injection. A covered or partially covered metal self- expanding stent is placed in the area of tumor stenosis by the conductor, symmetrically in relation to the area of tumor stenosis.
- interventionNames
- Procedure: Endoscopic self-expandable metal stent placement
- type
- PLACEBO_COMPARATOR
- label
- Stoma formation.
- description
- Anesthetic care will include general endotracheal anesthesia with positioning of nasogastric tube and bladder catheterization. The diverting stoma formation will be proceed in 10 sm proximally to tumor.
- interventionNames
- Procedure: Stoma formation
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients are 18 years old or older 2. Stage I-IV according to TNM classification 3. Patients with malignant colonic obstruction 4. Overall health status according to ASA classification: I-III 5. Overall health status according to Charlson comorbidity index ≤ 8 points 6. Signed informed consent with agreement to attend all study visits 7. The patient is not pregnant Exclusion Criteria: 1. Inflammatory bowel disease 2. Acute purulent process in the abdominal cavity 3. The patient wants to withdraw from the clinical trial 4. Loss to follow-up
References
Publications (10)
- BACKGROUNDCronin KA, Lake AJ, Scott S, Sherman RL, Noone AM, Howlader N, Henley SJ, Anderson RN, Firth AU, Ma J, Kohler BA, Jemal A. Annual Report to the Nation on the Status of Cancer, part I: National cancer statistics. Cancer. 2018 Jul 1;124(13):2785-2800. doi: 10.1002/cncr.31551. Epub 2018 May 22. PMID 29786848
- BACKGROUNDJemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin. 2011 Mar-Apr;61(2):69-90. doi: 10.3322/caac.20107. Epub 2011 Feb 4. PMID 21296855
- BACKGROUNDCheynel N, Cortet M, Lepage C, Benoit L, Faivre J, Bouvier AM. Trends in frequency and management of obstructing colorectal cancers in a well-defined population. Dis Colon Rectum. 2007 Oct;50(10):1568-75. doi: 10.1007/s10350-007-9007-4. PMID 17687610
- BACKGROUNDBaron TH. Colonic stenting: a palliative measure only or a bridge to surgery? Endoscopy. 2010 Feb;42(2):163-8. doi: 10.1055/s-0029-1243881. Epub 2010 Feb 5. PMID 20140833
- BACKGROUNDLarkin JO, Moriarity AR, Cooke F, McCormick PH, Mehigan BJ. Self-expanding metal stent insertion by colorectal surgeons in the management of obstructing colorectal cancers: a 6-year experience. Tech Coloproctol. 2014 May;18(5):453-8. doi: 10.1007/s10151-013-1073-0. Epub 2013 Oct 10. PMID 24114608
- BACKGROUNDKim EJ, Kim YJ. Stents for colorectal obstruction: Past, present, and future. World J Gastroenterol. 2016 Jan 14;22(2):842-52. doi: 10.3748/wjg.v22.i2.842. PMID 26811630
- BACKGROUNDMaleckis K, Anttila E, Aylward P, Poulson W, Desyatova A, MacTaggart J, Kamenskiy A. Nitinol Stents in the Femoropopliteal Artery: A Mechanical Perspective on Material, Design, and Performance. Ann Biomed Eng. 2018 May;46(5):684-704. doi: 10.1007/s10439-018-1990-1. Epub 2018 Feb 22. PMID 29470746