VIdeo Assisted Thoracoscopic Lobectomy Versus Conventional Open LobEcTomy for Lung Cancer

Summary

Lung cancer is the leading cause of cancer death worldwide and survival in the United Kingdom (UK) remains amongst the lowest in Europe. Surgery is the main method of managing early stage disease and is traditionally undertaken via conventional open surgery. However, over the last decade there has been a surge in the number of minimal access resections performed using Video-assisted thoracoscopic surgery (VATS). However, there remains a need for well-designed and conducted randomised controlled trial (RCT) to provide the evidence base for the wide spread uptake and delivery of this surgical approach.

Conditions

• Lung Neoplasms

Interventions

PROCEDURE

Open Surgery

Conventional open surgery is undertaken through a single incision +/- rib resection and with rib spreading. The operation is performed under direct vision with isolation of the hilar structures (vein, artery and bronchus) which are dissected, ligated and divided in sequence and the lobe of lung resected. The procedures may be undertaken using ligatures, over sewing or with staplers. Lymph node management is undertaken in accordance with the International Association of the Study of Lung Cancer (IASLC) recommendations where a minimal of 6 nodes / stations are removed, of which 3 are from the mediastinum that includes the subcarinal station. The thoracotomy is closed in layers starting from pericostal sutures over the ribs, muscle, fat and skin layers.

PROCEDURE

Video Assisted Thoracoscopic Surgery (VATS)

VATS lobectomy is undertaken through one to four keyhole incisions without rib spreading. The use of 'rib spreading' is prohibited as this is the key intra-operative manoeuvre which disrupts tissues and causes pain (and is used in open surgery). The procedure is performed with videoscopic visualisation without direct vision. The hilar structures are dissected, stapled and divided. Endoscopic ligation of pulmonary arterial branches may be performed. The fissure is completed and the lobe of lung resected. Lymph node management is the same as described for open surgery. The incisions are closed in layers and may involve muscle, fat and skin layers. This definition of VATS lobectomy is a modification of CALGB 39802.

Sponsors & Collaborators

• Royal Brompton & Harefield NHS Foundation Trust

  collaborator OTHER

• University of Oxford

  collaborator OTHER

• University of Bristol

  lead OTHER

Principal Investigators

• Chris Rogers · University of Bristol

• Eric Lim · Royal Brompton & Harefield NHS Foundation Trust

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

16 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-07-31

Primary Completion

2019-03-31

Completion

2020-03-31

Countries

• United Kingdom

Study Locations