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

NCT05807646 | Not Yet Recruiting DMC

• 1 other identifier: SichuanCHRI123
• Study Type: interventional
• Target: 268
• Locations: 0 countries
• Sites: N/A

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)

Conditions

Rectal Cancer

Outcome Measures

Primary Outcomes (1)

• 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

  During the surgery

Secondary Outcomes (10)

• 3-year disease-free survival

  From date of surgery, assessed up to 36 months

• 3-years overall survival

  From date of surgery, assessed up to 36 months

• Recurrence pattern

  From date of surgery, assessed up to 36 months

• Blood loss

  During the surgery

• Operation time

  During the surgery

Study Arms (2)

Vein ligation first

EXPERIMENTAL

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

Other: Vein ligation first

Artery ligation first

ACTIVE COMPARATOR

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

Other: Artery ligation first

Interventions

Vein ligation first OTHER

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

Vein ligation first

Artery ligation first OTHER

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

Artery ligation first

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sichuan Cancer Hospital and Research Institute: lead
• Sichuan Provincial People's Hospital: collaborator
• The Second People's Hospital of Chengdu: collaborator

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Chao Liu, Professor

  Sichuan Cancer Hospital and Research Institute

  STUDY DIRECTOR

Central Study Contacts

Tao Pan, Doctor

CONTACT

+86-18181986821; taopancd@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 29, 2023
• First Posted: April 11, 2023
• Study Start: January 1, 2025
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2028
• Last Updated: February 15, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share