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Randomized controlled trial of stent placement in patients with inoperable malignant colorectal obstruction (JIVROSG-0806)

Randomized controlled trial of stent placement in patients with inoperable malignant colorectal obstruction (JIVROSG-0806) - Randomized controlled trial of stent placement in patients with malignant colorectal obstruction

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000003572
Enrollment
32
Registered
2010-05-06
Start date
2009-11-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant colorectal obstruction

Interventions

Stent placement in the region of colonic stenosis. Other treatments except surgical intervention.

Sponsors

Japan Interventional Radiology in Oncology Study Group (JIVROSG)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Inoperable, symptomatic obstruction in rectum or sigmoid cancer. 2. No clinical obstruction in oral side GI tract. 3. Difficulty in surgical colostomy or no refusal by the patient. 4. Palliative prognosis index less than 6. 5. Written informed consent from the patients. 6. Twice measurement of symptom score and health-related quality-of-life.

Exclusion criteria

Exclusion criteria: 1. Indication for surgical colostomy. 2. Possibility of definitive surgery for colorectal obstruction. 3. Bleeding from the treatment area requiring hemostatic treatments. 4. More than 4 weeks after the beginning of the symptom from colorectal obstruction. 5. Clinically significant cardiac failure, renal failure, or bleeding tendency. 6. Difficulties in the evaluation of quality-of-life. 7. Pregnancy. 8. Contraindication decided by participating physician.

Design outcomes

Primary

MeasureTime frame
Improvement of the symptoms from colorectal obstruction.

Secondary

MeasureTime frame
Improvement of health-related QOL, toxicity profile, and survival time.

Countries

Japan

Contacts

Public ContactYasuaki Arai

National Cancer Center Hospital Division of Diagnostic Radiology

arai-y3111@mvh.biglobe.ne.jp03-3542-2511

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026