Effect of ligation sequence of the inferior mesenteric artery and vein on circulating tumor cells and survival in laparoscopic rectal cancer surgery: a prospective, multicenter, randomized controlled study (ARVECTS)
Several studies have demonstrated that the presence of circulating tumor cells (CTCs) in the peripheral blood can be a surrogate biomarker to predict recurrence and prognosis of rectal cancer. CTCs are released from the primary tumor into the bloodstream and have the potential to spread to distant sites and develop into micro-metastatic deposits. Numerous studies have demonstrated that surgical manipulation could promote the dissemination of tumor cells into the circulation. Theoretically, the potential risk of tumor cell dissemination can theoretically be minimized if the effluent vein was ligated first. However, there is no regulation in the current guidelines on the sequence of ligation of the inferior mesenteric artery and vein during rectal cancer surgery owing to a lack of sufficient evidence. This multi-center randomized controlled trial is to investigate effect of ligation sequence of the inferior mesenteric artery and vein on circulating tumor cells and survival in laparoscopic rectal cancer surgery
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
268
During this procedure, patients undergo laparoscopic rectal cancer surgery with the inferior mesenteric vein ligated first.
During this procedure, patients undergo laparoscopic rectal cancer surgery with the inferior mesenteric artery ligated first.
The changes of the level of circulating tumor cells in the peripheral blood
The changes of the level of circulating tumor cells in the peripheral blood before cutting the skin and after closing the abdomen
Time frame: During the surgery
3-year disease-free survival
The proportion of patients with no disease recurrence and metastasis after 3 years of surgery
Time frame: From date of surgery, assessed up to 36 months
3-years overall survival
The proportion of patients who survived 3 years after surgery
Time frame: From date of surgery, assessed up to 36 months
Recurrence pattern
Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type
Time frame: From date of surgery, assessed up to 36 months
Blood loss
Blood loss during the surgery
Time frame: During the surgery
Operation time
Operation time
Time frame: During the surgery
Conversive rate
Conversive rate
Time frame: During the surgery
Number of lymph nodes collected
Number of lymph nodes collected
Time frame: During the surgery
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Intraoperative morbidity and mortality rates
The intraoperative morbidity rates are defined as the rates of event observed within operation
Time frame: During the surgery
Postoperative morbidity and motality rates
This is for the early postoperative complication, which defined as the event observed within 30 days after surgery
Time frame: 30 days
Postoperative recovery course
Time to first ambulation, flatus, liquid diet and soft diet, duration of postoperative hospital stay and postoperative pain are used to assess the postoperative recovery course.Visual analog pain score method is used to evaluate the difference of postoperative pain degree
Time frame: 10 days