VIdeo Assisted Thoracoscopic Lobectomy Versus Conventional Open LobEcTomy for Lung Cancer

NCT03521375 | Completed DMC

• 1 other identifier: ORCA58877
• Study Type: interventional
• Target: 503
• Locations: 1 country
• Sites: 9

Brief 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

Keywords

lung; cancer; lobectomy

Outcome Measures

Primary Outcomes (1)

• Self-reported physical function using HRQoL questionnaire QLQ-C30

  Physical functioning scale, ranges between 0 and 100. High score indicates high level of physical functioning.

  5 weeks post randomisation

Secondary Outcomes (12)

• Time from surgery to hospital discharge, assessed up to 12 months

  Time from surgery to hospital discharge, assessed up to 12 months

• Adverse health events to 1 year

  Adverse health events to 1 year

• Proportion of patients taking up adjuvant treatment, assessed up to 12 months

  Proportion and time to uptake of adjuvant treatment, assessed up to 12 months

• Time to uptake of adjuvant treatment, assessed up to 12 months

  Proportion and time to uptake of adjuvant treatment, assessed up to 12 months

• Proportion of patients upstaged to pN2 disease after surgical procedure, assessed up to 3 months post surgery

  Proportion of patients upstaged to pN2 disease after surgical procedure, assessed up to 3 months post-surgery

Study Arms (2)

VATS lobectomy

EXPERIMENTAL

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.

Procedure: Video Assisted Thoracoscopic Surgery (VATS)

Open lobectomy

ACTIVE COMPARATOR

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: Open Surgery

Interventions

Open Surgery PROCEDURE

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.

Also known as: Open lobectomy

Open lobectomy

Video Assisted Thoracoscopic Surgery (VATS) PROCEDURE

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.

Also known as: VATS lobectomy

VATS lobectomy

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged ≥16 years of age
• Able to give written consent, undergoing either:
• i. Lobectomy or bilobectomy for treatment of known or suspected primary lung cancer beyond lobar orifice\* in TNM8 stage cT1-3 (by size criteria, equivalent to TNM7 stage cT1a-2b) or cT3 (by virtue of 2 nodules in the same lobe), N0-1 and M0 or ii. Undergoing frozen section biopsy with the intention to proceed with lobectomy or bilobectomy if primary lung cancer with a peripheral tumour beyond a lobar orifice\* in TNM8 stage cT1-3 (by size criteria, equivalent to TNM7 stage cT1a-2b) or cT3 (by virtue of 2 nodules in the same lobe), N0-1 and M0 is confirmed
• Disease suitable for both minimal access (VATS) and open surgery

You may not qualify if:

• Adults lacking capacity to consent
• Previous malignancy that influences life expectancy
• Patients in whom a pneumonectomy, segmentectomy or non-anatomic resection (e.g. wedge resection) is planned
• Patients with a serious concomitant disorder that would compromise patient safety during surgery.
• Planned robotic surgery

Sponsors & Collaborators

• University of Bristol: lead
• Royal Brompton & Harefield NHS Foundation Trust: collaborator
• University of Oxford: collaborator

Study Sites (9)

Heartlands Hospital

Birmingham, United Kingdom

Location

Bristol Royal Infirmary

Bristol, United Kingdom

Location

Royal Infirmary of Edinburgh

Edinburgh, United Kingdom

Location

Hull and East Yorkshire Hospitals NHS Trust

Hull, United Kingdom

Location

Liverpool Heart and Chest Hospital NHS Foundation Trust

Liverpool, United Kingdom

Location

Harefield Hospital

London, United Kingdom

Location

Royal Brompton Hospital

London, United Kingdom

Location

The James Cook University Hospital

Middlesbrough, United Kingdom

Location

Oxford University Hospitals NHS Foundation Trust

Oxford, United Kingdom

Location

Related Publications (1)

• Lim E, Batchelor T, Shackcloth M, Dunning J, McGonigle N, Brush T, Dabner L, Harris R, Mckeon HE, Paramasivan S, Elliott D, Stokes EA, Wordsworth S, Blazeby J, Rogers CA; VIOLET Trialists. Study protocol for VIdeo assisted thoracoscopic lobectomy versus conventional Open LobEcTomy for lung cancer, a UK multicentre randomised controlled trial with an internal pilot (the VIOLET study). BMJ Open. 2019 Oct 14;9(10):e029507. doi: 10.1136/bmjopen-2019-029507.

  PMID: 31615795 BACKGROUND

Related Links

• Protocol paper publication

MeSH Terms

Conditions

Lung Neoplasms; Neoplasms

Interventions

Conversion to Open Surgery; Thoracic Surgery, Video-Assisted

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Endoscopy; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Thoracoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Video-Assisted Surgery; Thoracic Surgical Procedures

Study Officials

• Chris Rogers

  University of Bristol

  STUDY DIRECTOR

• Eric Lim

  Royal Brompton & Harefield NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2018
• First Posted: May 11, 2018
• Study Start: July 1, 2015
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2020
• Last Updated: September 22, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (9)