Reduced Dissemination of Tumor Cells With Primary Ligation of the Inferior Mesenteric Vein in Rectal Cancer Patients.

Not Applicable

Not yet recruiting

• Conditions: Rectal Cancer
• Interventions: Other: Artery ligation first; Other: Vein ligation first

• Registration Number: NCT05807646
• Lead Sponsor: Sichuan Cancer Hospital and Research Institute

Brief 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

Study Timeline

• Study First Submitted: 2023-03-29
• Study First Submitted QC: 2023-03-29
• Study First Posted: 2023-04-11
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-14
• Last Update Posted: 2024-02-15
• Study Start: 2025-01
• Primary Completion: 2025-12
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 268

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Artery ligation first	Artery ligation first	During this procedure, patients undergo laparoscopic rectal cancer surgery with the inferior mesenteric artery ligated first.
Vein ligation first	Vein ligation first	During this procedure, patients undergo laparoscopic rectal cancer surgery with the inferior mesenteric vein ligated first.

Primary Outcome Measures

Name	Time	Method
The changes of the level of circulating tumor cells in the peripheral blood	During the surgery	The changes of the level of circulating tumor cells in the peripheral blood before cutting the skin and after closing the abdomen

Secondary Outcome Measures

Name	Time	Method
Blood loss	During the surgery	Blood loss during the surgery
Postoperative morbidity and motality rates	30 days	This is for the early postoperative complication, which defined as the event observed within 30 days after surgery
Postoperative recovery course	10 days	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
Number of lymph nodes collected	During the surgery	Number of lymph nodes collected
3-year disease-free survival	From date of surgery, assessed up to 36 months	The proportion of patients with no disease recurrence and metastasis after 3 years of surgery
3-years overall survival	From date of surgery, assessed up to 36 months	The proportion of patients who survived 3 years after surgery
Operation time	During the surgery	Operation time
Recurrence pattern	From date of surgery, assessed up to 36 months	Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type
Conversive rate	During the surgery	Conversive rate
Intraoperative morbidity and mortality rates	During the surgery	The intraoperative morbidity rates are defined as the rates of event observed within operation