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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01707888
Enrollment
500
Registered
2012-10-16
Start date
2014-09-30
Completion date
2017-06-30
Last updated
2015-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small Cell Lung Cancer

Brief summary

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.

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.

Interventions

PROCEDUREThoracoscopy/VATS

Patients undergo major lung resection by thoracoscopic surgery or video assisted thoracoscopic surgery.

Sponsors

Peking University People's Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
morbidity and mortility rate3 mothsperioperative complications and death rates of the group

Secondary

MeasureTime frameDescription
Rate of loco-regional and systemic recurrence3yTo evaluate the rate of loco-regional and systemic recurrence of the group.
Pulmonary function6 months after surgeryto evaluate the pulmonary function as measured by expiratory flow rate of the group 6 months postoperatively.
Postoperative hospital stay.3 months postoperativelyto evaluate the postoperative hospital stay of the group.
Disease-free survival3yTo evaluate Disease Free Survival (DFS) of the group.
overall survival3 months postoperativelyto evaluate the overall survival rate of the group.
converted rate3 monthsthe rate of converted thoracotomy
Postoperative drainage duration3 months postoperativelyto evaluate the postoperative drainage duration of the group.

Countries

China

Contacts

Primary ContactJun Wang, MD
Jwangmd@yahoo.com88324078

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026