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

NCT ID: NCT05807646

Last Updated: 2024-02-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 268 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-31
• Study Completion Date: 2028-12-31

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

Conditions

Rectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vein ligation first

During this procedure, patients undergo laparoscopic rectal cancer surgery with the inferior mesenteric vein ligated first.

Group Type: EXPERIMENTAL

Vein ligation first

Intervention Type: OTHER

During this procedure, patients undergo laparoscopic rectal cancer surgery with the inferior mesenteric vein ligated first.

Artery ligation first

During this procedure, patients undergo laparoscopic rectal cancer surgery with the inferior mesenteric artery ligated first.

Group Type: ACTIVE_COMPARATOR

Artery ligation first

Intervention Type: OTHER

During this procedure, patients undergo laparoscopic rectal cancer surgery with the inferior mesenteric artery ligated first.

Interventions

Vein ligation first

During this procedure, patients undergo laparoscopic rectal cancer surgery with the inferior mesenteric vein ligated first.

Intervention Type: OTHER

Artery ligation first

During this procedure, patients undergo laparoscopic rectal cancer surgery with the inferior mesenteric artery ligated first.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sichuan Provincial People's Hospital

OTHER

Sponsor Role: collaborator

The Second People's Hospital of Chengdu

OTHER

Sponsor Role: collaborator

Sichuan Cancer Hospital and Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Tao Pan

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chao Liu, Professor

Role: STUDY_DIRECTOR

Sichuan Cancer Hospital and Research Institute

Central Contacts

Tao Pan, Doctor

Role: CONTACT

taopancd@163.com

+86-18181986821

Other Identifiers

SichuanCHRI123

Identifier Type: -

Identifier Source: org_study_id