A phase II study of palliative treatment with metallic stents for inoperable malignant colorectal strictures. (JIVROSG-0206)

Phase 2

• Conditions: Inoperable malignant colorectal strictures.

• Registration Number: JPRN-C000000044
• Lead Sponsor: Japan Interventional Radiology in Oncology Study Group (JIVROSG)

Brief Summary

Technical success: 97.0% (32/33) Clinical success (SE+ME, ≥2w): 81.8% (27/33) Mortality within 30 days: 3 (progression of the primary disease) Clinical failure due to the obstruction of other sites: 1 Stent removal from anal pain: 1 Adverse events (grade 2-3): diarrhea 12, pain 5, bleeding 1, dysuria 1

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-08-06
• Study Completion: 2007-02-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

Not provided

Exclusion Criteria

1) The operation for colostomy scheduled. 2) Stenting as the preoperative preparation for the resection. 3) Serious bleeding from the lesion. 4) Pregnancy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement of subjective symptoms at 1 day, 1,2 and 4 weeks after stenting.

Secondary Outcome Measures

Name	Time	Method
Adverse events, improvement of abdominal radiography findings at 1 day, 1,2 and 4 weeks after stenting.