Is Video-assisted Thoracoscopic Lobectomy a Clinical Alternative for Surgically Resectable Pathologic N2 NSCLC Patients

August 7, 2018 updated by: lixiaofei, Tang-Du Hospital

Vedio-assisted Thoracoscopic Lobectomy vs Open Lobectomy for Patients With Surgically Resectable Pathologic N2 NSCLC

The study was designed to compare the safety and effectiveness of vedio-assisted thoracoscopic lobectomy with open lobectomy for patients with surgically resectable pathologic N2 non-small cell lung cancer

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The is a multi-center retrospective study. Patients with pathologic N2 NSCLC who underwent VATS or open lobectomy between 2014 and 2017 were included into this study. Clinical data on patient demographic, clinical characteristics, treatment and clinical outcomes will be collected to evaluate the safety and effectiveness of video-assisted thoracoscopic lobectomy for pathologic N2 NSCLC.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2145

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
    • Beijing
      • Beijing, Beijing, China, 100029
        • China-Japan Friendship Hospital
      • Beijing, Beijing, China, 100853
        • China PLA General Hospital
    • Henan
      • Zhengzhou, Henan, China, 450003
        • Henan Cancer Hospital
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Tongji Hospital Affiliated to Huazhong Technology Hospital
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Jiangsu Cancer Hospital
    • Shaanxi
      • Xi'an, Shaanxi, China, 710000
        • Xi'an Tangdu Hospital
    • Shanghai
      • Shanghai, Shanghai, China, 200030
        • Shanghai Chest Hospital
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Huaxi Hospital Affiliated to Sichuan University
    • Tianjin
      • Tianjin, Tianjin, China, 300051
        • Tianjin Chest Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • First Hospital Affiliated to Zhejiang University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Pathologically diagnosed N2 non-small cell lung cancer who received VATS or thoracotomy lobectomy between 2014 and 2017

Description

Inclusion Criteria:

  • Patients with age > 18 years old;
  • Patients with pathologically diagnosed non-small cell lung cancer;
  • Patients underwent lobectomy by either VATS or thoracotomy between 2014 and 2017;
  • Patients who received lymphadenectomy for all accessible lymph nodes;
  • Patients with N2 lymph nodes (+) after surgeries;

Exclusion Criteria:

  • Patients with second primary tumors or multiple primary tumors;
  • Patients who received chest surgeries before hospitalization;
  • Patients with superior pulmonary sulcus tumor

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
VATS lobectomy
Pathologic N2 NSCLC patients who received lobectomy by video-assisted thoracoscopic surgery
Procedure: VATS lobectomy
Patients who received lobectomy by video-assisted thoracoscopic surgery
Thoracotomy lobectomy
Pathologic N2 NSCLC patients who received lobectomy by thoracotomy
Procedure: Thoracotomy lobectomy
Patients who received lobectomy by thoracotomy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 2014-2018
Overall survival
2014-2018

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Duration of hospital stay [Perioperative outcomes]
Time Frame: 2014-2017
Duration of hospital stay [Perioperative outcomes]
2014-2017
Postoperative 30 and 90 days [Perioperative outcomes]
Time Frame: 2014-2017
Postoperative 30 and 90 days [Perioperative outcomes]
2014-2017
Drainage time [Perioperative outcomes]
Time Frame: 2014-2017
Drainage time [Perioperative outcomes]
2014-2017
Intraoperative blood loss [Perioperative outcomes]
Time Frame: 2014-2017
Intraoperative blood loss [Perioperative outcomes]
2014-2017
Postoperative complications [Perioperative outcomes]
Time Frame: 2014-2017
Postoperative complications [Perioperative outcomes]
2014-2017

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall survivals in the subgroups stratified by T staging
Time Frame: 2014-2018
Overall survivals in the subgroups stratified by T staging
2014-2018
Overall survivals in the subgroups stratified by neoadjuvant therapy
Time Frame: 2014-2018
Overall survivals in the subgroups stratified by neoadjuvant therapy
2014-2018
Overall survivals in the subgroups stratified by number of lymph node station involved
Time Frame: 2014-2018
Overall survivals in the subgroups stratified by number of lymph node station involved
2014-2018
Impact factors for overall survival
Time Frame: 2014-2018
Impact factors for overall survival
2014-2018
Impact factors for postoperative mortality within 30/90 days
Time Frame: 2014-2017
Impact factors for postoperative mortality within 30/90 days
2014-2017
Propensity score matching analysis of overall survival
Time Frame: 2014-2018
Propensity score matching analysis of overall survival
2014-2018
Propensity score matching analysis of perioperative outcomes
Time Frame: 2014-2018
Propensity score matching analysis of perioperative outcomes
2014-2018
Propensity score matching analysis of impact factors for overall survival
Time Frame: 2014-2018
Propensity score matching analysis of impact factors for overall survival
2014-2018
Propensity score matching analysis of impact factors for postoperative mortality within 30/90 days
Time Frame: 2014-2018
Propensity score matching analysis of impact factors for postoperative mortality within 30/90 days
2014-2018

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tang-Du Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
LinkDoc Technology (Beijing) Co. Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Xiaofei Li, PhD, Tang-Du Hospital

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 4, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 4, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 6, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 16, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 3, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 9, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 7, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • W-TONG06

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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