VATS Lobectomy for Clinical Stage IB or II Lung Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00425022|
Recruitment Status : Unknown
Verified January 2007 by National Cancer Center, Korea.
Recruitment status was: Recruiting
First Posted : January 22, 2007
Last Update Posted : January 30, 2007
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Non-Small-Cell Lung Thoracic Surgery, Video-Assisted||Procedure: thoracoscopy||Phase 2|
Video-assisted or minimally invasive surgery has become the standard approach for many abdominal surgical operations such as cholecystectomy and fundoplication. With respect to the thorax, video-assisted thoracoscopic surgery(VATS) is the accepted technique for biopsy of the lung and pleura and surgical treatment of pneumothorax.Thoracoscopic, also termed video-assisted thoracoscopic lobectomy has become accepted as a safe and effective procedure to treat early-stage non-small cell lung cancer (NSCLC). Several pilot series of thoracoscopic lobectomy in stage I lung cancer patients have been reported, demonstrating low complication rates and effective short-term and long-term oncologic results. With increasing experience, the indications for thoracoscopic lobectomy have been expanded. Single and Multi-institutional studies have demonstrated that thoracoscopic lobectomy is not only a safe and feasible technique, but is also associated with decreased morbidity, including shorter length of hospitalization and chest tube duration, decreased postoperative pain, improved preservation of pulmonary function, reduced inflammatory response as measured by lower postoperative cytokine levels, and shorter recovery time, as compared with conventional thoracotomy. The advantages of thoracoscopic lobectomy have been demonstrated in patients with clinical stage I NSCLC, and this strategy has been found to be particularly useful for specific subsets of patients such as the elderly and those patients with poor performance status.
The purpose of this study is to know whether VATS lobectomy for clinical stage IB or II non-small cell lung cancer is possible.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Feasibility of VATS(Video-Assisted Thoracoscopic Surgery) Lobectomy for Clinical Stage IB or II Non-Small Cell Lung Cancer|
|Study Start Date :||January 2007|
- To examine the feasibility of VATS lobectomy for clinical stage IB or II non-small cell lung cancer.
- Success is defined as VATS lobectomy without conversion.
- If success rate over 90%, VATS lobectomy is considered as feasible procedures for clinical stage IB or II non-small cell lung cancer
- To evaluate the number of dissected lymph nodes and the rate of contamination during lymph node dissection according to the lymph node stations under VATS
- To estimate the reccurrence rate (locoregional and distant metastasis)
- To estimate the overall survival
- To evaluate the intraoperative(surgical duration, estimated blood loss) and postoperative variables(mortality, morbidity, chest tube drainage duration, wound pain, hospital stay)
- To evaluate inflammatory mediators after VATS
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00425022
|Contact: Hyun-Sung Lee, MD, PhDfirstname.lastname@example.org|
|Korea, Republic of|
|National Cancer Center||Recruiting|
|Goyang, Gyeonggi, Korea, Republic of, 411-769|
|Contact: Hyun-Sung Lee, MD, PhD +82-31-920-1648 email@example.com|
|Sub-Investigator: Jae Ill Zo, MD,PhD|
|Sub-Investigator: Jong Mog Lee, MD|
|Sub-Investigator: Moon Soo Kim, MD|
|Sub-Investigator: Bin Hwangbo, MD|
|Sub-Investigator: Hee Seok Lee, MD|
|Sub-Investigator: Hyae Young Kim, MD, PhD|
|Sub-Investigator: Kun Young Lim, MD|
|Sub-Investigator: Soo-Hyun Lee, MD|
|Sub-Investigator: Geon Kook Lee, MD, PhD|
|Sub-Investigator: Moon Woo Seong, MD|
|Sub-Investigator: Byoung-ho Nam, PhD|
|Principal Investigator:||Hyun-Sung Lee, MD, PhD||National Cancer Center, Korea|