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

Lung Cancer Clinical Trial

— CTC-01  

Official title:

Impact of the Sequence of Vessel Interruption During Major Pulmonary Resections for Non-small Cell Lung Cancer Based on Circulating Tumor Cells Detection Peroperatively in the Tumor-draining Pulmonary Vein: a Randomized Pilot Study.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03645252
• Other study ID #: 2019-2997, 21621
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 31, 2018
• Est. completion date: August 31, 2024

Study information

• Verified date: August 2018
• Source: Laval University
• Contact: Conti Massimo, MD
• Phone: +14186568711
• Email: massimo.conti[@]criucpq.ulaval.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Circulating Tumor Cell
• Lung Cancer
• Lung Neoplasms
• Neoplastic Cells, Circulating
• Surgery

Intervention

Procedure:
• 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.
• 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.

Locations

Country	Name	City	State
Canada	Institut Universitaire de Cardiologie et de Pneumologie de Québec	Québec

Sponsors (2)

Lead Sponsor	Collaborator
Laval University	Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Country where clinical trial is conducted

Canada, 

References & Publications (2)

Crosbie PA, Shah R, Krysiak P, Zhou C, Morris K, Tugwood J, Booton R, Blackhall F, Dive C. Circulating Tumor Cells Detected in the Tumor-Draining Pulmonary Vein Are Associated with Disease Recurrence after Surgical Resection of NSCLC. J Thorac Oncol. 2016 — View Citation

Hashimoto M, Tanaka F, Yoneda K, Takuwa T, Matsumoto S, Okumura Y, Kondo N, Tsubota N, Tsujimura T, Tabata C, Nakano T, Hasegawa S. Significant increase in circulating tumour cells in pulmonary venous blood during surgical manipulation in patients with pr — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in CTC density	Changes in CTC count in 7.5 ml of blood sampled from the tumor-draining vein between the period before surgical manipulation (first sample) and before tumor-draining vein interruption (second sample).	Within 96 hours after surgery
Primary	Changes in CTC clusters density	Changes in CTC clusters (or CTC micro-emboli defined as =3 contiguous CTC) count in 7.5 ml of blood sampled from the tumor-draining vein between the period before surgical manipulation (first sample) and before tumor-draining vein interruption (second sample).	Within 96 hours after surgery
Secondary	Disease free survival	Disease free survival 2 years and 5 years after surgery and recurrence site (local or distant metastasis).	2 years and 5 years after surgery
Secondary	Overall survival	Overall survival 2 years and 5 years after surgery.	2 years and 5 years after surgery