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

ConditionRectal Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSichuan Cancer Hospital and Research Institute

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Vein ligation first

    Other intervention

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

  • Artery ligation first

    Other intervention

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

Treatment groups

268 Participants
are divided into 2 treatment groups
Group A: Vein ligation firstExperimental treatment 1 intervention
Group B: Artery ligation firstActive comparator 1 intervention

Trial outcomes

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

Time frame
During the surgery

Secondary outcomes

1

3-year disease-free survival

The proportion of patients with no disease recurrence and metastasis after 3 years of surgery

Time frame
From date of surgery, assessed up to 36 months
2

3-years overall survival

The proportion of patients who survived 3 years after surgery

Time frame
From date of surgery, assessed up to 36 months
3

Recurrence pattern

Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type

Time frame
From date of surgery, assessed up to 36 months
4

Blood loss

Blood loss during the surgery

Time frame
During the surgery

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sichuan Cancer Hospital and Research Institute

Lead sponsor

Sichuan Provincial People's Hospital

Collaborator

The Second People's Hospital of Chengdu

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: