Sequence of Vessel Interruption and Circulating Tumor Cells in Surgical Lung Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-31

Study Completion Date

2024-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Circulating Tumor Cell Lung Cancer Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Vein first

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

Group Type ACTIVE_COMPARATOR

Vein interruption before any other surgical manipulation

Intervention Type PROCEDURE

The pulmonary tumor-drainage vein is first exposed and punctured with a 23-gauge needle, and 7.5 ml of blood is drawn from the pulmonary vein prior to subsequent surgical manipulation for lobectomy. Collected blood is versed in a Cellsearch tube provided by the manufacturer (Menarini Silicon Biosystems, Castel Maggiore, Italy).

In the "vein first" group, the lobar vein is dissected and the cartridge and anvil of a vascular cartridge stapler are placed on either side of the vein. The vein is punctured above the stapler with a 23-gauge needle and 7.5 ml of blood is drawn. Finally, the vein is cut. The intervention then proceeds in the usual manner.

Arteries before vein

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

Group Type ACTIVE_COMPARATOR

Arteries interruption before vein interruption

Intervention Type PROCEDURE

The pulmonary tumor-drainage vein is first exposed and punctured with a 23-gauge needle, and 7.5 ml of blood is drawn from the pulmonary vein prior to subsequent surgical manipulation for lobectomy. Collected blood is versed in a Cellsearch tube provided by the manufacturer (Menarini Silicon Biosystems, Castel Maggiore, Italy).

In the "arteries before vein" group, lobar arteries are first dissected and interrupted (+/- the bronchus and inter-lobar fissures). The lobar vein is then dissected and blood sample is performed as described above.

Interventions

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Vein interruption before any other surgical manipulation

The pulmonary tumor-drainage vein is first exposed and punctured with a 23-gauge needle, and 7.5 ml of blood is drawn from the pulmonary vein prior to subsequent surgical manipulation for lobectomy. Collected blood is versed in a Cellsearch tube provided by the manufacturer (Menarini Silicon Biosystems, Castel Maggiore, Italy).

In the "vein first" group, the lobar vein is dissected and the cartridge and anvil of a vascular cartridge stapler are placed on either side of the vein. The vein is punctured above the stapler with a 23-gauge needle and 7.5 ml of blood is drawn. Finally, the vein is cut. The intervention then proceeds in the usual manner.

Intervention Type PROCEDURE

Arteries interruption before vein interruption

The pulmonary tumor-drainage vein is first exposed and punctured with a 23-gauge needle, and 7.5 ml of blood is drawn from the pulmonary vein prior to subsequent surgical manipulation for lobectomy. Collected blood is versed in a Cellsearch tube provided by the manufacturer (Menarini Silicon Biosystems, Castel Maggiore, Italy).

In the "arteries before vein" group, lobar arteries are first dissected and interrupted (+/- the bronchus and inter-lobar fissures). The lobar vein is then dissected and blood sample is performed as described above.

Intervention Type PROCEDURE

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No