VATS Major Lung Resection for Chinese Early-stage Non-small Cell Lung Cancer

VATS Major Lung Resection for Chinese Early-stage Non-small Cell Lung cancer-a Registry Study

Surgery may be the best treatment choice for early stage non-small cell lung cancer. And VATS major lung resection have been preferred as a standard radical procedure for early stage non-small cell lung cancer (NSCLC).This study aim to investigate the outcome of VATS major lung resection for lung cancer as a real-world study in china.

Study Overview

• Status: Unknown
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Procedure: Thoracoscopy/VATS

Detailed Description

Surgery may be the best treatment choice for early stage non-small cell lung cancer. And VATS major lung resection have been preferred as a standard radical procedure for early stage non-small cell lung cancer (NSCLC).This study aim to investigate the outcome of VATS major lung resection for lung cancer as a real-world study in china.This is a multicenter, prospective study, aimed To evaluate the short-term and long- term outcome of VATS major lung resection for early stage lung cancer. Patients will be followed up every 3 months for 3 years.

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Peking University People's Hospital
    • Contact: Jun Wang, MD
  • Beijing, China
    • Not yet recruiting
    • Beijing Friendship Hospital
    • Contact: Zhi Gao
  • Beijing
    • Beijing, Beijing, China, 100044
      • Not yet recruiting
      • Beijing Anzhen Hospital
      • Contact: Songlei Ou
    • Beijing, Beijing, China, 100044
      • Not yet recruiting
      • Beijing Cancer hospital
      • Contact: Keneng Chen
    • Beijing, Beijing, China, 100044
      • Not yet recruiting
      • Beijing Chao-Yang Hospital
      • Contact: Hui Li
    • Beijing, Beijing, China, 100044
      • Recruiting
      • Beijing Haidian Hospital
      • Contact: Yuqing Huang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

clinical early stage(I/II) lung cancer

Description

Inclusion Criteria:

Preoperative criteria:

i) non-small cell lung cancer is suspected, ii) clinical stage I/II (3) Intraoperative criteria: i) Histologically confirmed NSCLC, ii) resected by VATS or converted open lobectomy,sleeve lobectomy or pneumonectomy and nodal dissection/sampling.

(4) No prior ipsilateral thoracotomy (prior diagnostic thoracoscopy is allowed).

(5) No prior chemotherapy or radiation therapy for any malignant diseases. (6) Expected postoperative FEV1.0>=800 mL and PaO2>=65 torr. (7) Performance status of 0 or 1. (8) Sufficient organ functions. (9) Written informed consent.

Exclusion Criteria:

1. Active bacterial or fungous infection.
2. Simultaneous or metachronous (within the past 5 years) double cancers.
3. Women during pregnancy or breast-feeding.
4. Interstitial pneumonitis, pulmonary fibrosis, or severe pulmonary emphysema.
5. Psychosis.
6. Systemic steroids medication.
7. Uncontrollable diabetes mellitus.
8. Uncontrollable hypertension.
9. History of severe heart disease, heart failure, myocardial infarction within the past 6 months or attack of angina pectoris within the past 6 months.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
major lung resection; Patients undergo major lung resection by thoracoscopy/VATS.	Procedure: Thoracoscopy/VATS; Patients undergo major lung resection by thoracoscopic surgery or video assisted thoracoscopic surgery.; Other Names: Minimal invasive surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
morbidity and mortility rate	perioperative complications and death rates of the group	3 moths

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease-free survival	To evaluate Disease Free Survival (DFS) of the group.	3y
Rate of loco-regional and systemic recurrence	To evaluate the rate of loco-regional and systemic recurrence of the group.	3y
Pulmonary function	to evaluate the pulmonary function as measured by expiratory flow rate of the group 6 months postoperatively.	6 months after surgery
Postoperative hospital stay.	to evaluate the postoperative hospital stay of the group.	3 months postoperatively
Postoperative drainage duration	to evaluate the postoperative drainage duration of the group.	3 months postoperatively
overall survival	to evaluate the overall survival rate of the group.	3 months postoperatively
converted rate	the rate of converted thoracotomy	3 months

Collaborators and Investigators

• Sponsor: Peking University People's Hospital
• Investigators: Study Director: Fan Yang, MD, Peking University People's Hospital; Study Chair: Jun Wang, MD, Peking University People's Hospital; Study Director: Zhao Xi Sui, MD, Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Anticipated): June 1, 2017
• Study Completion (Anticipated): June 1, 2017

Study Registration Dates

• First Submitted: October 13, 2012
• First Submitted That Met QC Criteria: October 15, 2012
• First Posted (Estimate): October 16, 2012

Study Record Updates

• Last Update Posted (Estimate): January 27, 2015
• Last Update Submitted That Met QC Criteria: January 24, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: PEKUPH1201