cStage II/III obstructive colorectal cancer
Conditions
Interventions
Following enrollment, a covered stent will be placed as soon as possible, within 3 days, using a stent with a diameter of 20 to 22 mm. The insertion procedure and management after stent placement will
s policy. Covered stents currently approved for clinical use in Japan will be used, specifically NitiS, Hanaro, and Jabara.
Following enrollment, an uncovered stent will be placed as soon as possible,
s policy. Uncovered stents currently approved for clinical use in Japan will be used, specifically Niti-S, Hanaro, Jentlly, and Ajiro.
Sponsors
Department of Gastroenterology, Hiroshima University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must meet all of the following criteria: Patients diagnosed with colorectal cancer presenting with obstructive symptoms caused by the primary tumor, confirmed by abdominal CT or other imaging examinations. Patients whose primary tumor is located in the ascending colon (A), transverse colon (T), descending colon (D), sigmoid colon (S), rectosigmoid (RS), or upper rectum (Ra). Patients with obstructive symptoms corresponding to a CROSS (ColoRectal Obstruction Scoring System) score of 0, 1, or 2 at the time of consent. Patients scheduled to undergo curative resection of the primary tumor. Patients preoperatively diagnosed as stage II or III without evidence of distant metastasis on imaging examinations. Patients who have not undergone surgical resection or chemotherapy for colorectal cancer within the past 5 years. Patients who have not received surgery, radiotherapy, or chemotherapy for any other malignancy within the past 1 year. Patients aged 20 to 90 years at the time of consent. Patients with an ECOG Performance Status (PS) of 0, 1, or 2 at the time of consent. Patients who have provided written informed consent of their own free will, or whose consent has been obtained from a legally authorized representative.
Exclusion criteria
Exclusion criteria: Patients meeting any of the following criteria will be excluded from the study: Patients diagnosed with synchronous multiple advanced colorectal cancers on CT or other imaging examinations. Patients with active malignancies in other organs (excluding intraepithelial carcinoma or intramucosal carcinoma that can be cured by local therapy). Patients whose primary colorectal tumor is located within 5 cm from the anal verge. Patients with inflammatory bowel disease or polyposis syndromes. Pregnant or potentially pregnant women, or women who are breastfeeding. Patients with severe organ dysfunction. Patients who have previously been enrolled in this trial. Patients deemed inappropriate for participation in this study by the principal investigator or sub-investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of vascular invasion, Relapse-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, Disease-free survival, Technical success rate of stent placement, Clinical success rate of stent placement, Bridge-to-surgery (BTS) success rate, Complication rate related to stent placement, Perioperative complication rate, Primary anastomosis rate, Perineural invasion rate | — |
Countries
Japan
Contacts
Public ContactTakuro Hamada
Hiroshima University Hospital Department of Gastroenterology
Outcome results
None listed