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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Shanghai Chest Hospital
Shanghai Pulmonary Hospital, Shanghai, China
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Shenzhen People's Hospital
Information provided by (Responsible Party):
Hao Long, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01102517
First received: April 6, 2010
Last updated: May 11, 2017
Last verified: May 2017
  Purpose

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.

Condition Intervention
Non-small Cell Lung Cancer Procedure: video-assisted thoracoscopic surgery Procedure: axillary thoracotomy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Outcomes Assessor
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Hao Long, Sun Yat-sen University:

Primary Outcome Measures:
  • Disease-free survival and overall survival [ Time Frame: 5 years ]

Secondary Outcome Measures:
  • Quality of life [ Time Frame: the first year after the surgery ]
    Lung Cancer Symptom Scale

  • Postoperative pulmonary function [ Time Frame: the first three months after the surgery ]
  • Postoperative Karnofsky performance status [ Time Frame: 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

  • Perioperation data [ Time Frame: perioperation ]
    operation time, intraoperative blood loss, chest tube drainage amount, duration of the chest tube placement, and duratio

  • Cytokines response [ Time Frame: the first 48 hours after the surgery ]
    IL-2,IL-4,IL-6,IL-10,TNF,IFN-r


Enrollment: 500
Study Start Date: January 2010
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VATS group
video-assisted thoracoscopic surgery
Procedure: video-assisted thoracoscopic surgery
video-assisted thoracoscopic surgery
axillary thoracotomy
Control group
Procedure: axillary thoracotomy
axillary thoracotomy lobectomy

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01102517

Locations
China, Guangdong
Sun Yat-sen University Cancer Center
GuangZhou, Guangdong, China, 510060
Sponsors and Collaborators
Sun Yat-sen University
Shanghai Chest Hospital
Shanghai Pulmonary Hospital, Shanghai, China
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Shenzhen People's Hospital
Investigators
Principal Investigator: Hao Long, professor Sun Yat-sen University
  More Information

Additional Information:
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.

Responsible Party: Hao Long, Sun Yat-sen University Cancer Center, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01102517     History of Changes
Other Study ID Numbers: 2007039
Study First Received: April 6, 2010
Last Updated: May 11, 2017

Keywords provided by Hao Long, Sun Yat-sen University:
NSCLC
Clinical
Early-stage

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms

ClinicalTrials.gov processed this record on July 24, 2017