A Trial on Video-assisted Thoracoscopic Surgery and Axillary Thoracotomy for Resection of Early-stage Non-small Cell Lung Cancer

February 27, 2018 updated by: Hao Long, Sun Yat-sen University

The purpose of this study is to establish the effects of VATS lobectomy for early-stage non-small cell lung cancer.

The aims of this study are:

  1. To evaluate the early clinical benefits of VATS lobectomy when compared with the axillary thoracotomy.
  2. To evaluate the late effects of VATS lobectomy on survival and quality of life when compared with axillary thoracotomy.
  3. To establish the normative pattern of VATS lobectomy for early-stage non-small cell lung cancer.
  4. To explore the indication of VATS lobectomy for the lung cancer.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • GuangZhou, Guangdong, China, 510060
        • Sun Yat-Sen University Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Early stage NSCLC and no metastasis of hilum of lung and mediastinum lymph nodes (short diameter ≤ 1 cm) on computed tomography (CT) scan;
  • No medical contraindications to lung resection
  • Age ≤ 75 years old and ≥18 years old;
  • Sign the informed consent form.

Exclusion Criteria:

  • Evidence of invasion into neighboring organs;
  • Extensive pleura adhesion;
  • Central lesion;
  • Not suitable for single-lung ventilation;
  • Had history of thoracotomy and radiation for thoracic region ;
  • Pregnancy or lactation female patients;
  • Cannot sign the informed consent form because of psychological, family and society factors;
  • Had history of other malignant tumors within 5 years except for non-melanoma cutaneous cancer, uterine cervix cancer in situ and curative early-stage carcinoma of prostate;
  • Participants can not accept operation for other uncontrolled factors.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VATS group
video-assisted thoracoscopic surgery
Procedure: video-assisted thoracoscopic surgery
video-assisted thoracoscopic surgery
Other: axillary thoracotomy
Control group
Procedure: axillary thoracotomy
axillary thoracotomy lobectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Disease-free survival and overall survival
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life
Time Frame: the first year after the surgery
Lung Cancer Symptom Scale
the first year after the surgery
Postoperative pulmonary function
Time Frame: the first three months after the surgery
the first three months after the surgery
Postoperative Karnofsky performance status
Time Frame: the first year after the surgery
the first year after the surgery
Postoperative Chest Pain
Time Frame: the first year after the surgery
visual analogue scale and Wong-Baker FACES Pain Rating Scale
the first year after the surgery
Perioperation data
Time Frame: perioperation
operation time, intraoperative blood loss, chest tube drainage amount, duration of the chest tube placement, and duratio
perioperation
Cytokines response
Time Frame: the first 48 hours after the surgery
IL-2,IL-4,IL-6,IL-10,TNF,IFN-r
the first 48 hours after the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Collaborators

Shanghai Chest Hospital
Shenzhen People's Hospital
Shanghai Pulmonary Hospital, Shanghai, China
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Investigators

  • Principal Investigator: Hao Long, professor, Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 1.Bethencourt DM, Holmes EC. Muscle-sparing posterolateral thoracotomy. Ann Thorac Surg. 1988;45(3):337-339. 2.Ginsberg RJ. Alternative (muscle-sparing) incisions in thoracic surgery. Ann Thorac Surg. 1993;56(3):752-754. 3.Weissberg D, Kaufman M. Technical aids in surgery. Two muscle-sparing thoracotomies--techniques and indications. S Afr J Surg. 1990;28(1):17-19. 4.Akçali Y, Demir H, Tezcan B. The effect of standard posterolateral versus muscle-sparing thoracotomy on multiple parameters. Ann Thorac Surg. 2003;76(4):1050-1054. 5.Hazelrigg SR, Landreneau RJ, Boley TM, et al. The effect of muscle-sparing versus standard posterolateral thoracotomy on pulmonary function, muscle strength, and postoperative pain. J Thorac Cardiovasc Surg. 1991;101(3):394-400. 6.Kutlu CA, Akin H, Olcmen A, et al. Shoulder-girdle strength after standard and lateral muscle-sparing thoracotomy. Thorac Cardiovasc Surg. 2001;49(2):112-114. 7.Khan IH, McManus KG, McCraith A, et al. Muscle sparing thoracotomy: a biomechanical analysis confirms preservation of muscle strength but no improvement in wound discomfort. Eur J Cardiothorac Surg. 2000;18(6):656-661. 8.Baeza OR, Foster ED. Vertical axillary thoracotomy: a functional and cosmetically appealing incision. Ann Thorac Surg. 1976;22(3):287-288.
  • Long H, Tan Q, Luo Q, Wang Z, Jiang G, Situ D, Lin Y, Su X, Liu Q, Rong T. Thoracoscopic Surgery Versus Thoracotomy for Lung Cancer: Short-Term Outcomes of a Randomized Trial. Ann Thorac Surg. 2018 Feb;105(2):386-392. doi: 10.1016/j.athoracsur.2017.08.045. Epub 2017 Dec 2.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

April 6, 2010

First Submitted That Met QC Criteria

April 12, 2010

First Posted (Estimate)

April 13, 2010

Study Record Updates

Last Update Posted (Actual)

February 28, 2018

Last Update Submitted That Met QC Criteria

February 27, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007039

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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