Modified Video-assisted Thoracoscopic Surgery (VATS) Lobectomy for Early-stage Non-small Cell Lung Cancer (NSCLC)

Peking University

Status: Unknown

Conditions: Lung Cancer

Treatments: Procedure: Standard VATS lobectomy; Procedure: Open lobectomy; Device: VATS lobectomy using modified equipments; Procedure: VATS lobectomy using less staples

Study type: Observational

Funder types: Other

Identifiers

NCT01337037

PHTD2010

Details and patient eligibility

About

The purpose of this study is to modify the surgical technique of VATS (video-assisted thoracoscopic surgery) lobectomy for early-stage non-small cell lung cancer.

Full description

VATS (video-assisted thoracoscopic surgery) lobectomy is a relatively new minimally invasive surgical treatment for early-stage non-small cell lung cancer (NSCLC), associated with low morbidity and mortality and effective oncologic results over the standard thoracotomy. However, this surgical procedure has not spread widely in china for several reasons. First , VATS surgery cost more than thoracotomy for thoracoscopic staples; second, the procedure of VATS lobectomy may be more difficult in china as the lack of VATS surgical equipments adjusted for smaller thoracic cavity of chinese, and more common adhesive and calcified lymph nodes due to infection and tuberculosis; Third, the surgical levels of VATS lobectomy are far from equal in china, and the Continuing Medical Education training programs of thoracoscopic surgery seem to be less efficient without major criterion.

The purpose of this study is to modify the surgical technique of VATS (video-assisted thoracoscopic surgery) lobectomy for early-stage non-small cell lung cancer, to examine the feasibility of VATS lobectomy performed by less staples, and to evaluate the feasibility of VATS lobectomy performed by modified surgical equipments designed according to the experience of chinese lobectomy surgery, and to generate a chinese standard operative procedure of VATS lobectomy for technique learning and spread. The investigators will intend to recruit 250 patients each group, for 4 groups. Group A(open group) will undergo radical lobectomy via thoracotomy approach. Group B(standard VATS group) will undergo lobectomy via standard VATS approach introduced. Group C(less staples group) will undergo lobectomy via VATS approach with staples limitation. Group D(modified equipments group) will undergo lobectomy via VATS approach using VATS surgical equipments designed according to the experience of chinese lobectomy surgery. The investigators will compare two groups of patients as followed: A vs. B, B vs. C, B vs. D.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. clinically diagnosed with stage I to stage II peripheral non-small cell lung cancer suitable for lobectomy.
2. signed informed consent from patient or legal representative, and allowed adequate follow-up.
3. operators must have experience of VATS lobectomy for more than 50 cases.

Exclusion criteria

1. pregnant or breastfeeding women.
2. severe complications or infections.
3. no prior chemotherapy or radiotherapy for this malignancy.
4. medical history of mediastinal or hilar lymphadenopathy.
5. current participation in another study involving an investigational device or drug.

Trial design

1,000 participants in 4 patient groups

standard VATS group

Description:

patients undergo standard VATS lobectomy using non-modified equipments,without limits of staples

Treatment:

Procedure: Standard VATS lobectomy

modified equipments group

Description:

patients undergo VATS lobectomy with modified VATS lobectomy equipments designed designed according to the experience of chinese lobectomy surgery: Lobectomy Equipments Pack (Manufacturer B.J.ZH.F.Panther Medical Equipment Co.,Ltd.).

Treatment:

Device: VATS lobectomy using modified equipments

less staples group

Description:

patients undergo VATS lobectomy with at most 4 staples used.

Treatment:

Procedure: VATS lobectomy using less staples

open group

Description:

patients undergo lobectomy by thoracotomy approach

Treatment:

Procedure: Open lobectomy