Sequence of Vessel Interruption and Circulating Tumor Cells in Surgical Lung Cancer (CTC-01)

Laval University

Status: Not yet enrolling

Conditions: Surgery; Lung Cancer; Circulating Tumor Cell

Treatments: Procedure: Arteries interruption before vein interruption; Procedure: Vein interruption before any other surgical manipulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03645252

2019-2997, 21621

Details and patient eligibility

About

This study aims to define the impact of the sequence of vessel interruption on change in CTC and CTC clusters density in the tumor-draining pulmonary vein between the period before surgical manipulation and before tumor-draining vein interruption.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• NSCLC with preoperative pathological evidence,
• Pure solid nodule or part-solid (>50%) ground glass nodule on CT scan
• Clinical stage tumor-1 to 3, clinical stage node-0, clinical stage metastasis-0, (except clinical stage tumor-3 for chest wall, pericardium or phrenic nerve invasion)
• Video-assisted thoracoscopic lobectomy or bi-lobectomy

Exclusion criteria

• Pneumonectomy, segmentectomy, non anatomic resection
• History of thoracic surgery on the same side
• Necessity to perform a non-anatomic resection in addition to the lobectomy
• No preoperative histological diagnosis
• Pure ground glass nodule on CT scan
• Clinical stage tumor-4 or 3 for chest wall, pericardium or phrenic nerve invasion
• Clinical stage node ≥1
• Neoadjuvant therapy
• Second cancer or cancer in the past 5 years
• First approach through thoracotomy with ribs spreading
• Pregnancy, <18 years of age
• Pulmonary adherences/symphysis found during surgery (impossible to perform the first blood sample without lung manipulation)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Vein first

Active Comparator group

Description:

Tumor-draining pulmonary vein is interrupted first and before any surgical manipulation.

Treatment:

Procedure: Vein interruption before any other surgical manipulation

Arteries before vein

Active Comparator group

Description:

Lobar arteries (+/- bronchus and inter-lobar fissures) are interrupted before tumor-draining pulmonary vein.

Treatment:

Procedure: Arteries interruption before vein interruption