Inoperable malignant colorectal strictures.
Conditions
Interventions
A bare stent is placed in the stenotic portion of sigmoid colon or rectum caused by malignant tumor via the trans-anal route.
Sponsors
Japan Interventional Radiology in Oncology Study Group (JIVROSG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Symptomatic acute colonic obstruction due to unresectable malignant tumor of sigmoid colon or rectum. 2) Stenosis or obstruction of sigmoid colon or rectum confirmed by colography. The lesion confined within the lower margin more than 5cm distant from the anal ring, and the higher margin up to the level of the iliac crest. 3) No clinically definitive obstruction in upper gastrointestional tract other than sigmoid colon or rectal lesion. 4) Adequate cardiac, hepatic, renal, respiratory, and bone marrow functions. 5) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3. 6) Expected survival more than 4 weeks. 7) Written informed consent.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement of subjective symptoms at 1 day, 1,2 and 4 weeks after stenting. | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events, improvement of abdominal radiography findings at 1 day, 1,2 and 4 weeks after stenting. | — |
Countries
Japan
Contacts
Public ContactYasuaki Arai
JIVROSG, Coordinating Office Division of Diagnostic Radiology, National Cancer Center Hospital
Outcome results
None listed