Reduced Dissemination of Tumor Cells With Primary Ligation of the Inferior Mesenteric Vein in Rectal Cancer Patients.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vein ligation first, Artery ligation first.
- Who it may be relevant to
- Registry conditions: Rectal Cancer. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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)
Overview
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)
Detailed description
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
Interventions
- Other Vein ligation first
During this procedure, patients undergo laparoscopic rectal cancer surgery with the inferior mesenteric vein ligated first. - Other Artery ligation first
During this procedure, patients undergo laparoscopic rectal cancer surgery with the inferior mesenteric artery ligated first.
Primary outcome measures
- The changes of the level of circulating tumor cells in the peripheral blood [Time frame: During the surgery]
Secondary outcome measures (10)
- 3-year disease-free survival [Time frame: From date of surgery, assessed up to 36 months]
- 3-years overall survival [Time frame: From date of surgery, assessed up to 36 months]
- Recurrence pattern [Time frame: From date of surgery, assessed up to 36 months]
- Blood loss [Time frame: During the surgery]
- Operation time [Time frame: During the surgery]
- Conversive rate [Time frame: During the surgery]
- Number of lymph nodes collected [Time frame: During the surgery]
- Intraoperative morbidity and mortality rates [Time frame: During the surgery]
- Postoperative morbidity and motality rates [Time frame: 30 days]
- Postoperative recovery course [Time frame: 10 days]
Eligibility criteria
Inclusion criteria
- Age: 18-75 years;
- Histopathologically confirmed as rectal adenocarcinoma(tumor located within 15 cm from the anal verge at colonoscopy);
- Patients with a stage I-III rectal cancer eligible for surgery and R0 resection is expected, patients with pelvic lateral lymph nodes metastasis are ineligible;
- ECOG score: 0-1;
- ASA score: I/II/III;
- Laparoscopic surgery;
- Informed consent.
Exclusion criteria
- Patients who have received preoperative treatment (such as preoperative radiotherapy and chemotherapy);
- Receiving transanal total mesorectal excision (taTME), specimen extraction through natural lumen (NOSES) ;
- Recurrent rectal cancer;
- Simultaneous or metachronous colorectal cancer;
- Malignant tumors of other organs in the past 5 years or at the same time;
- The results of preoperative physical examination and imaging examination showed that: (1) the tumor involved the surrounding organs and required combined organ resection; (2) distant metastasis; (3) could not be resected at R0;
- Pregnant or lactating women;
- Patients with severe mental disorder;
- It is not suitable for patients undergoing laparoscopic surgery (such as extensive adhesion caused by previous abdominal surgery or inability to tolerate artificial pneumoperitoneum);
- History of unstable angina pectoris or myocardial infarction in the past 6 months;
- Have a history of cerebrovascular accident in the past 6 months;
- Systemic administration of corticosteroids within 1 month before enrollment;
- Taking folic acid related drugs within half a year before operation.
- Severe cardiac insufficiency (FEV1<50% of predicted values);
- Emergency surgery.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Pan T, Hu H, Liu C, Zhou HY. Effect of ligation sequence of the inferior mesenteric artery and vein on circulating tumour cells and survival in minimally invasive rectal cancer surgery: study protocol for a randomised controlled trial (ARVECTS study). BMJ Open. 2025 Nov 19;15(11):e098428. doi: 10.1136/bmjopen-2024-098428. PMID 41263842
Identifiers
NCT: NCT05807646 · SichuanCHRI123