Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200062, China
Location status: Recruiting
NCT Number: NCT06934018
The main objective of this study was to evaluate the effect of surgical margin width on the prognosis of patients with hepatic oligometastasis of colorectal cancer by statistical 1-year intrahepatic recurrence-free survival rate (ihRFSrate). The secondary objective of the study was to evaluate the effect of surgical margin width on long-term survival and total recurrence of colorectal cancer in patients with hepatohepatic metastasis by statistical overall survival time (OS) and relapse-free survival time (RFS), and to evaluate the safety of wide margin surgery compared with narrow margin surgery in patients with Cromitis during perioperative period.
This was a single-center, prospective, randomized controlled clinical study to evaluate the effects of surgical margin width on 1-year intrahepatic relapse-free survival, relapse-free survival time, overall survival time, and perioperative safety in patients with hepatic oligometastasis of colorectal cancer. Subjects will undergo radical resection of liver tumors and will be randomly assigned to a wide margin group (≥7mm) or narrow margin group (<7mm) using stratified randomization, stratified by primary lesion site (right colon vs left colon/rectum). The margin width was the narrowest margin distance measured in fresh specimens. After radical liver tumor resection, subjects were pretreated regularly Follow-up evaluation.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Shanghai, Shanghai Municipality, 200062, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
According to the "Chinese Guidelines for the Diagnosis and Comprehensive Treatment of Liver metastases of Colorectal Cancer (2023 edition)", R0 resection of metastatic tumors is satisfied, and the objective is to preserve sufficient functional liver tissue, and the surgical margin width is less than 7mm
Time frame: From liver tumor resection to 1 year after surgery
Refers to the percentage of subjects in this group who received intrahepatic imaging diagnosis of recurrence or death from any cause from surgery to 1 year after surgery.
Time frame: 12 months
The earliest date from the date of receipt of liver tumor resection to the date of confirmation of tumor recurrence or the date of death from any cause. Regular follow-up visits were conducted until the end of the study follow-up
Time frame: 24 months
Refers to the time from liver tumor resection to death from any cause, if the above criteria were not met, the date of the last evaluation was used for analysis.
Time frame: Patient 90 days after hepatectomy
In this study, the incidence of perioperative complications was calculated according to Clavien Dindo complication scoring system. At the same time, perioperative death, operative time, intraoperative blood loss, blood transfusion and other surgical safety treatment were counted
Contact information is provided by the study sponsor or research team.
Fudan University
Other
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