Colorectal cancer
Conditions
Interventions
Colonic stenting within 7 days and primary tumor resection within 3-30 days after allocation
After management by fasting or liquid intake, primary tumor resection within 3-30 days after allocation
Sponsors
NPO JORTC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Radiologically (Abdominal and pelvic CT) or endoscopically proven colonic stricture presumed secondary to a carcinoma 2) Primary tumor should be located in one of ascending colon, transverse colon, descending colon, sigmoid colon or rectosigmoid colon, and a lesion which is located in ileocecal valve, rectum above the peritoneal reflection, or rectum less than 10cm from anal verge is excluded. 3) Colonic stricture which is impossible to be passed through by colonoscope including a small-caliber one, and the degree of colonic stricture is estimated as colorectal obstruction scoring system (CROSS) 1 or 2. 4) Colonic stricture presumed secondary to a carcinoma by preoperative imaging modalities such as abdominal and chest X-ray, abdominal and pelvic CT, chest CT, abdominal MRI, abdominal ultrasound or FDG-PET 5) Patient with at least one of the following obstructive findings; 1. Intolerable for oral intake or necessary for fasting at the judgement of the attending physician 2. No fart 3. Bloating or abdominal pain 4. Abnormality of defecation such as constipation or frequent diarrhea 5. Nausea or vomiting 6) Patient without gastrointestinal decompressive procedure such as long intestinal tube, transanal drainage tube or colonic stenting 7) Patient diagnosed as stage II or III colorectal cancer in preoperative imaging modalities such as abdominal and chest X-ray, abdominal and pelvic CT, chest CT, abdominal MRI, abdominal ultrasound or FDG-PET 8) Patient with ECOG performance status of 0, 1, or 2 9) Patient aged 20 to 90 10) Patient without chemotherapy or radiotherapy for any cancer when allocated 11) Organ function is preserved 12) Written informed consent to participation in this trial
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival at 3 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival Relapse-free survival Quality of life Incidence of obstructive symptoms (Bloating, abdominal pain/crump, deterioration of bowel habit, nausea or vomiting) before surgery Incidence of emergency surgery Withdrawal rate of continuous infusion IV Technical success rate of colonic stenting Clinical success rate of colonic stenting Clinical success rate of colonic stenting at BTS Complication rate and onset period with colonic stenting Perioperative complication rate Primary anastomosis rate Permanent stoma formation rate Induction rate of adjuvant chemotherapy | — |
Countries
Japan
Contacts
Public ContactShuntaro Yoshida
University of Tokyo Gastroenterology
Outcome results
None listed