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

Not Applicable

• Conditions: Lung Cancer; Surgery; Circulating Tumor Cell
• Interventions: Procedure: Artery ligation first; Procedure: Vein ligation first

• Registration Number: NCT03436329
• Lead Sponsor: West China Hospital

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2016-12-01
• Study First Submitted: 2018-02-05
• Study First Submitted QC: 2018-02-15
• Study First Posted: 2018-02-19
• Primary Completion: 2018-05-31
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-09
• Last Update Posted: 2020-10-12
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Artery ligation first	Artery ligation first	During this procedure, patients undergo lobectomy with the pulmonary artery ligated first.
Vein ligation first	Vein ligation first	During this procedure, patients undergo lobectomy with the pulmonary vein ligated first.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
3-year Progression-Free-Survival	From date of the recruitment, assessed up to 36 months	From the date of recruitment until the date of progression of lung cancer assessed up to 36 months
Operative time	During the surgery	Operative time during the surgery
Blood loss	During the surgery	Blood loss during the surgery
Morbidity	Within 30 days after surgery	Complications resulting from surgery, such as pneumonia, air leak and arrhythmia.
Length of stay	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	The length of patients staying in hospital from the date of checking in to the date of checking out

Trial Locations

Locations (1)

West China Hospital, Sichuan University; 🇨🇳 Chendu, Sichuan, China