Reduced Dissemination of Tumor Cells With Primary Ligation of the Vein in Patients With Lung Cancer

West China Hospital60 enrolled

Overview

The purpose of this study is to assess the impact of the sequence of vessel interruption in lung cancer patients on tumor cell spread and patient survival by using peripheral blood circulating tumor cells.

Circulating tumor cells (CTCs) in the peripheral blood can be a biomarker to predict tumor recurrence and survival. Handling the tumor during a surgery may promote the release of CTCs into the bloodstream. Therefore, in a surgery of cancer, interruption of the vein before ligation of the artery may be justified. This multi-center randomized controlled trial is to assess the impact of the sequence of vessel interruption in lung cancer patients on tumor cell spread and patient survival by using peripheral blood CTCs.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Lung Cancer Surgery Circulating Tumor Cell

Interventions

Vein ligation firstPROCEDURE

During this procedure, patients undergo lobectomy with the pulmonary vein ligated first.

Artery ligation firstPROCEDURE

During this procedure, patients undergo lobectomy with the pulmonary artery ligated first.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients with stage I-IV lung cancer eligible for surgery 2. Patients undergoing the completely thoracoscopic lobectomy 3. The nodule size was more than 2.5 cm 4. Patients consenting for intraoperative blood sampling Exclusion Criteria: 1. Patients who underwent primary wedge resection and open lobectomy 2. Patients who received neoadjuvant therapy before surgery

Locations (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Outcomes

Primary Outcomes

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 chest

Time frame: Intraoperative

Secondary Outcomes

3-year Progression-Free-Survival

From the date of recruitment until the date of progression of lung cancer assessed up to 36 months

Time frame: From date of the recruitment, assessed up to 36 months

Blood loss

Blood loss during the surgery

Time frame: During the surgery

Operative time

Operative time during the surgery

Time frame: During the surgery

Length of stay

The length of patients staying in hospital from the date of checking in to the date of checking out

Time frame: From date of admission until the date of discharging or date of death from any cause in hospital, whichever came first, assessed up to 30 days

Morbidity

Complications resulting from surgery, such as pneumonia, air leak and arrhythmia.

Time frame: Within 30 days after surgery

Data from ClinicalTrials.gov

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