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Trial Title:
Reduced Dissemination of Tumor Cells With Primary Ligation of the Inferior Mesenteric Vein in Rectal Cancer Patients.
NCT ID:
NCT05807646
Condition:
Rectal Cancer
Conditions: Official terms:
Rectal Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Vein ligation first
Description:
During this procedure, patients undergo laparoscopic rectal cancer surgery with the
inferior mesenteric vein ligated first.
Arm group label:
Vein ligation first
Intervention type:
Other
Intervention name:
Artery ligation first
Description:
During this procedure, patients undergo laparoscopic rectal cancer surgery with the
inferior mesenteric artery ligated first.
Arm group label:
Artery ligation first
Summary:
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
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age: 18-75 years;
2. Histopathologically confirmed as rectal adenocarcinoma(tumor located within 15 cm
from the anal verge at colonoscopy);
3. 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;
4. ECOG score: 0-1;
5. ASA score: I/II/III;
6. Laparoscopic surgery;
7. Informed consent.
Exclusion Criteria:
1. Patients who have received preoperative treatment (such as preoperative radiotherapy
and chemotherapy);
2. Receiving transanal total mesorectal excision (taTME), specimen extraction through
natural lumen (NOSES) ;
3. Recurrent rectal cancer;
4. Simultaneous or metachronous colorectal cancer;
5. Malignant tumors of other organs in the past 5 years or at the same time;
6. 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;
7. Pregnant or lactating women;
8. Patients with severe mental disorder;
9. It is not suitable for patients undergoing laparoscopic surgery (such as extensive
adhesion caused by previous abdominal surgery or inability to tolerate artificial
pneumoperitoneum);
10. History of unstable angina pectoris or myocardial infarction in the past 6 months;
11. Have a history of cerebrovascular accident in the past 6 months;
12. Systemic administration of corticosteroids within 1 month before enrollment;
13. Taking folic acid related drugs within half a year before operation.
14. Severe cardiac insufficiency (FEV1<50% of predicted values);
15. Emergency surgery.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
January 2025
Completion date:
December 2028
Lead sponsor:
Agency:
Sichuan Cancer Hospital and Research Institute
Agency class:
Other
Collaborator:
Agency:
Sichuan Provincial People's Hospital
Agency class:
Other
Collaborator:
Agency:
The Second People's Hospital of Chengdu
Agency class:
Other
Source:
Sichuan Cancer Hospital and Research Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05807646
