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

Authors
Category Primary study
Registry of TrialsUMIN Clinical Trials Registry
Year 2017
INTERVENTION: 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 CONDITION: Colorectal cancer PRIMARY OUTCOME: Disease‐free survival at 3 years SECONDARY OUTCOME: 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 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 o
Epistemonikos ID: 02040314f9a60be8fd051ee73f6c1ca0f877c745
First added on: Aug 23, 2024