Condition category
Cancer
Date applied
27/11/2014
Date assigned
28/11/2014
Last edited
24/03/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Contact information

Type

Public

Primary contact

Mr Timothy Brush

ORCID ID

Contact details

Clinical Trials & Evaluation Unit
School of Clinical Sciences
Level 7
Bristol Royal Infirmary
Marlborough Street
Bristol
BS2 8HW
United Kingdom
+44 (0)117 342 2987
violet-study@bristol.ac.uk

Type

Scientific

Additional contact

Mr Eric Lim

ORCID ID

Contact details

Academic Division of Thoracic Surgery
The Royal Brompton Hospital
Sydney Street
London
SW3 6NP
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 13/04/03

Study information

Scientific title

VIdeo-assisted thoracoscopic lobectomy versus conventional Open LobEcTomy for lung cancer: a multi-centre randomised controlled trial with an internal pilot

Acronym

VIOLET

Study hypothesis

VIOLET is an interventional study to evaluate the effectiveness, cost effectiveness and acceptability of VATS vs open surgery for early stage lung cancer. The hypothesis is that VATS surgery is superior to open surgery with respect to self-reported physical function 5 weeks after randomisation (approx. 1 month after surgery).

More details can be found at http://www.nets.nihr.ac.uk/projects/hta/130403

Ethics approval

NRES Committee London - Dulwich, 07/01/2015, ref: 14/LO/2129

Study design

Pragmatic multi-centre parallel-group randomised controlled trial with an internal pilot phase (phase 1)

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Lung cancer (stage cT1a-2b N0-1 M0)

Intervention

Trial participants will be randomised to lobectomy via VATS or open surgery in a 1:1 ratio.

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.

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 six nodes/stations are removed, of which three are from the mediastinum that includes the subcarinal station.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

The primary endpoint is self-reported physical function (QLQ-C30) at 5 weeks post randomisation. Physical function has been chosen because it is a patient-centred outcome that will reflect the anticipated earlier recovery with video-assisted surgery and has been used in other minimal access surgery trials. The primary endpoint has been chosen to be 5 weeks (1 month post-surgery) to capture the early benefits of minimal access surgery on recovery.

Secondary outcome measures

1. Time from surgery to hospital discharge
2. Adverse health events
3. Proportion and time to uptake of adjuvant treatment
4. Proportion of patients upstaged to pN2 disease after the procedure
5. Overall and disease-free survival to 1 year
6. Proportion of patients who undergo complete resection during the procedure
7. Proportion of patients who experience prolonged incision pain (defined as the need of analgesia > 6 weeks after surgery)
8. Generic and disease-specific HRQoL: EORTC QLQ-C30, QLQ-LC13 and EQ5D to 1 year (measured at 2 week, 5 weeks, 3 months, 6 months and 1-year post randomisation)
9. Resource use to 1 year (measured for the duration of post-operative hospital stay until discharge, and at 2 weeks, 5 weeks, 3 months, 6 months and 1-year post randomisation)

Overall trial start date

01/01/2015

Overall trial end date

01/09/2020

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adults aged ≥16 years of age
2. Able to give written consent, undergoing either:
2.1. Lobectomy for treatment of known or suspected primary lung cancer beyond lobular orifice in stage cT1a-2b N0-1 M0 or
2.2. Undergoing frozen section biopsy with the intention to proceed with lobectomy if primary lung cancer with a peripheral tumour beyond a lobular orifice in stage cT1a-2b N0-1 M0 is confirmed
3. Disease suitable for both minimal access (VATS) and open surgery

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

498 (Phase 1: 162, Phase 2: 338)

Participant exclusion criteria

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

Recruitment start date

01/07/2015

Recruitment end date

01/03/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Brompton Hospital
Sydney Street
London
SW3 6NP
United Kingdom

Trial participating centre

Harefield Hospital
Hill End Road
Harefield
UB9 6JH
United Kingdom

Trial participating centre

Bristol Royal Infirmary
Upper Maudlin Street
Bristol
BS2 8HW
United Kingdom

Trial participating centre

Liverpool Heart & Chest Hospital
Thomas Drive
Liverpool
L14 3PE
United Kingdom

Trial participating centre

James Cook University Hospital (Middlesbrough)
Marton Road
Middlesbrough
TS4 3BW
United Kingdom

Trial participating centre

Oxford University Hospitals - Churchill Hospital
Headley Way
Oxford
OX3 9DU
United Kingdom

Trial participating centre

Newcastle - Freeman Hospital
Freeman Road High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom

Trial participating centre

Papworth Hospital
Papworth Everard
Cambridge
CB23 3RE
United Kingdom

Sponsor information

Organisation

Royal Brompton & Harefield NHS Foundation Trust

Sponsor details

Research Office
Chelsea Wing
Sydney Street
London
SW3 6NP
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Not defined

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

24/03/2016: Ethics approval information added.