Dataset Information

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).

ABSTRACT:

Introduction

Lung cancer is a leading cause of cancer deaths worldwide and surgery remains the main treatment for early stage disease. Prior to the introduction of video-assisted thoracoscopic surgery (VATS), lung resection for cancer was undertaken through an open thoracotomy. To date, the evidence base supporting the different surgical approaches is based on non-randomised studies, small randomised trials and is focused mainly on short-term in-hospital outcomes.

Methods and analysis

The VIdeo assisted thoracoscopic lobectomy versus conventional Open LobEcTomy for lung cancer study is a UK multicentre parallel group randomised controlled trial (RCT) with blinding of outcome assessors and participants (to hospital discharge) comparing the effectiveness, cost-effectiveness and acceptability of VATS lobectomy versus open lobectomy for treatment of lung cancer. We will test the hypothesis that VATS lobectomy is superior to open lobectomy with respect to self-reported physical function 5?weeks after randomisation (approximately 1?month after surgery). Secondary outcomes include assessment of efficacy (hospital stay, pain, proportion and time to uptake of chemotherapy), measures of safety (adverse health events), oncological outcomes (proportion of patients upstaged to pathologic N2 (pN2) disease and disease-free survival), overall survival and health related quality of life to 1?year. The QuinteT Recruitment Intervention is integrated into the trial to optimise recruitment.

Ethics and dissemination

This trial has been approved by the UK (Dulwich) National Research Ethics Service Committee London. Findings will be written-up as methodology papers for conference presentation, and publication in peer-reviewed journals. Many aspects of the feasibility work will inform surgical RCTs in general and these will be reported at methodology meetings. We will also link with lung cancer clinical studies groups. The patient and public involvement group that works with the Respiratory Biomedical Research Unit at the Brompton Hospital will help identify how we can best publicise the findings.

Trial registration number

ISRCTN13472721.

SUBMITTER: Lim E

PROVIDER: S-EPMC6797374 | biostudies-literature | 2019 Oct

REPOSITORIES: biostudies-literature

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Publications

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).

Lim Eric E Batchelor Tim T Shackcloth Michael M Dunning Joel J McGonigle Niall N Brush Tim T Dabner Lucy L Harris Rosie R Mckeon Holly E HE Paramasivan Sangeetha S Elliott Daisy D Stokes Elizabeth A EA Wordsworth Sarah S Blazeby Jane J Rogers Chris A CA

BMJ open 20191014 10

<h4>Introduction</h4>Lung cancer is a leading cause of cancer deaths worldwide and surgery remains the main treatment for early stage disease. Prior to the introduction of video-assisted thoracoscopic surgery (VATS), lung resection for cancer was undertaken through an open thoracotomy. To date, the evidence base supporting the different surgical approaches is based on non-randomised studies, small randomised trials and is focused mainly on short-term in-hospital outcomes.<h4>Methods and analysis ...[more]

PMID: 31615795

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Project description:BACKGROUND:In recent years, the technique of uniportal video-assisted thoracoscopic surgery has been developed. As a new surgical method, its feasibility and safety have not been generally recognized. The aim of this study is to review the technology in the treatment of lung cancer patients in stage I to part of stage IIIa. METHODS:The clinical data of patients accepted thoracoscopic resection of lung cancer by a same medical group from May 2018 to March 2019 in The First Affiliated Hospital of Soochow University were retrospectively analyzed. After remove of cases that did not meet the requirements, the patients were divided into uniportal group (55 cases) and biportal group (87 cases). The clinical data of the two groups were collected and statistically analyzed. RESULTS:All the 142 patients underwent lobectomy and systemic lymph node dissection. There is no perioperative death in both groups. There was no significant difference in age, location of tumors, pathological type, size of tumors and pathological tumor-node-metastasis (pTNM) staging between uniportal group and biportal group (P>0.05). The operation time [(167.65±43.85) min vs (181.71±51.28) min], the intraoperative bleeding volume [(57.45±50.19) mL vs (87.47±132.54) mL], the indwelling time of drainage tube [(4.82±2.82) d vs (5.84±3.43) d] and the hospital stay [(6.91±3.88) d vs (7.74±3.87) d] were less in uiportal group compared to biportal group, though no significant difference occurred (P>0.05 ). The total drainage volume of uniportal group was significantly lower than that of biportal group [(1,064.82±776.38) mL vs (1,658.71±1,722.38) mL], and the visual analogue score of 24 hours and 72 hours after operation [(4.73±0.73) points vs (5.25±0.74) points; (2.16±0.71) points vs (2.55±0.86) points] were lower in uniportal group (P<0.05). CONCLUSIONS:Uniportal video-assisted thoracoscopic radical resection of lung cancer is safe and feasible for stage I to part of stage IIIa lung cancer patients.

Project description:RATIONALE:Video-assisted thoracoscopic surgery (VATS) and open lobectomy are both standard of care for the treatment of early-stage non-small cell lung cancer (NSCLC) because of equivalent long-term survival. OBJECTIVES:To evaluate whether the improved perioperative outcomes associated with VATS lobectomy are explained by surgeon characteristics, including case volume and specialty training. METHODS:We analyzed the Surveillance, Epidemiology, and End Results-Medicare-linked registry to identify stage I-II NSCLC in patients above 65 years of age. We used a propensity score model to adjust for differences in patient characteristics undergoing VATS versus open lobectomy. Perioperative complications, extended length of stay, and perioperative mortality among patients were compared after adjustment for surgeon's volume and specialty using linear mixed models. We compared survival using a Cox model with robust standard errors. RESULTS:We identified 9,508 patients in the registry who underwent lobectomy for early-stage NSCLC. VATS lobectomies were more commonly performed by high-volume surgeons (P?<?0.001) and thoracic surgeons (P?=?0.01). VATS lobectomy was associated with decreased adjusted odds of cardiovascular complications (odds ratio [OR]?=?0.65; 95% confidence interval [CI]?=?0.47-0.90), thromboembolic complications (OR?=?0.47; 95% CI?=?0.38-0.58), extrapulmonary infections (OR?=?0.75; 95% CI?=?0.61-0.94), extended length of stay (OR?=?0.47; 95% CI?=?0.40-0.56), and perioperative mortality (OR?=?0.33; 95% CI?=?0.23-0.48) even after controlling for differences in surgeon volume and specialty. Long-term survival was equivalent for VATS and open lobectomy (hazard ratio?=?0.95; 95% CI?=?0.85-1.08) after controlling for patient and tumor characteristics, surgeon volume, and specialization. CONCLUSIONS:VATS lobectomy for NSCLC is associated with better postoperative outcomes, but similar long-term survival, compared with open lobectomy among older adults, even after controlling for surgeon experience.

Dataset Information

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).

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

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).

Similar Datasets

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