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Treatment of Early Stage Lung Cancer by VATS Versus OPEN Lobectomy

NCT01933828 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 176

Last updated 2013-11-08

No results posted yet for this study

Summary

In patients with early stage lung cancer surgical lobectomy is the treatment of choice. A resection by Video-assisted Thoracic Surgery (VATS) is probably superior to an open procedure by thoracotomy for patients with early stage lung cancer, but randomized evidence for superiority is lacking. Furthermore, VATS lobectomy has not gained broad implementation yet. The objective of this study is to assess the benefits of VATS- over open lobectomy regarding quality of life and costs in a prospective randomized controlled multicenter trial. All patients meeting the inclusion criteria that are not randomized will be included in a prospective Cohort.

Conditions

Interventions

PROCEDURE

OPEN lobectomy

Lobectomy and mediastinal lymph node dissection by thoracotomy with rib-spreading.

PROCEDURE

VATS lobectomy

Thoracoscopic minimally invasive lobectomy with thoracoscopic mediastinal lymph node dissection without rib-spreading.

DEVICE

ROBOT-assisted lobectomy

Robot-assisted lobectomy with mediastinal lymph node dissection (Robot group as clinical assignment in prospective Cohort).

Sponsors & Collaborators

  • University Medical Center Nijmegen

    collaborator OTHER

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • A. Verhagen, MD · Radboud University Nijmegen Medical Center, Department of Cardio-thoracic Surgery Route 677 Postbus 9101, 6500 HB Nijmegen Tel: + 31 24 361 47 44 Fax: +31 24 354 01 29

  • T. van Brakel, MD, PhD · Radboud University Nijmegen Medical Center, Department of Cardio-thoracic Surgery Route 677 Postbus 9101, 6500 HB Nijmegen Tel: + 31 24 361 47 44 Fax: +31 24 354 01 29

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01933828 on ClinicalTrials.gov