A Prospective, Randomized, Open, Parallel-controlled, Superior-efficacy Clinical Study of Radical… (NCT06396806) | Clinical Trial Compass
By InvitationNot Applicable
A Prospective, Randomized, Open, Parallel-controlled, Superior-efficacy Clinical Study of Radical Sigmoidectomy for Sigmoid Cancer Versus Radical Sigmoidectomy Combined with Indocyanine Green Fluorescence Imaging Lymphatic Tracing Dissection in the Treatment of Sigmoid Cancer
China1,072 participantsStarted 2024-05-06
Plain-language summary
he purpose of this study is to explore the clinical outcomes of Indocyanine Green Tracer using in laparoscopic radical sigmoidectomy for sigmoid adenocarcinoma (cT2-T4a N0 M0，T1-T4a N+ M0).
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Age between 18 and 75 years old
✓. Confirmed sigmoid adenocarcinoma cancer pathologically
✓. Location of tumor: the sigmoid colon (descending colon from vertical to horizontal point) is the starting point of sigmoid colon, and the end point of sigmoid colon is at 15cm of anal margin.
✓. CT showed sigmoid colon cancer: T3-4a N+ M0
✓. Patients with non-local recurrence or distant metastasis;
✓. no multiple colorectal cancer;
✓. no neoadjuvant therapy;
✓. physical conditions such as heart, lung, liver and kidney function can tolerate surgery.
Exclusion criteria
✕. Complicated with other malignant tumors or previous history of malignant tumors;
✕. patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc.;
✕. patients with tumor invasion or involvement of adjacent organs requiring combined organ resection;
✕. patients with poor anal function and incontinence before operation;
✕. patients with inflammatory bowel disease or familial adenomatous polyposis
. ASA grade ≥ IV and / or ECOG physical status score \> 2;
✕. patients with severe hepatorenal function, cardiopulmonary function, blood coagulation dysfunction or severe underlying diseases unable to tolerate surgery;