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Colonic stent for "Bridge to Surgery" prospective randomized controlled trial comparing treatment with non-stenting surgery in stage II/III obstructive colon cancer

Phase 3
Recruiting
Conditions
Colorectal cancer
Registration Number
JPRN-UMIN000026158
Lead Sponsor
PO JORTC
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
420
Inclusion Criteria

Not provided

Exclusion Criteria

1) Synchronous multiple malignancy or metachronous multiple malignancy within 5 years disease free interval (Carcinoma in situ or other early carcinoma is excluded) 2) Women who are pregnant, possible to be pregnant or provide breastfeeding 3) Patient with severe comorbidity of heart, lung, liver and kidney 4) Patient with cerebrovascular disorder including unstable angina, myocardial infarction, cerebral hemorrhage, cerebral infarction, transient cerebral ischemia or thromboembolism within 6 months before registration 5) Patient with aortic dissection or aortic aneurysm of more than 5cm in abdomen or more than 6cm in thorax 6) Patient with diathesis of bleeding or coagulopathy because of decrease in platelets/clotting factor (excluding coagulopathy with preventive antithrombotic agents) 7) History of hemoptysis with bright red blood more than teaspoon 1/2 cup [2.5ml]) within 4 weeks 8) Patient with infectious disease to need systemic treatment 9) History of fistula, gastrointestinal perforation, or abscess in the abdominal cavity 10) Patient with difficulty in participation to clinical trial because of psychosis or mental disorder 11) Any other cases who are regarded as inadequate for study enrollment by investigators

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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