Non-small Cell Lung CancerPhase 2VATSNCT00997724
Assisted-VATS Sleeve Lobectomy for Non-small Cell Lung Cancer
A Phase 2 study testing a-VATS in people with Non-small Cell Lung Cancer, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial summary
The purpose of this study is to examine the feasibility of assisted-VATS (video-assisted thoracoscopic surgery) sleeve lobectomy for non-small cell lung cancer for non-small cell lung cancer. Success is defined as assisted-VATS sleeve lobectomy without conversion. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- a-VATS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Feb 1996to Jan 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed non-small cell lung cancer (Squamous, adenosquamous, large cell, or poorly differentiated)
- Patients with central tumors located at the origin of a lobar bronchus.
- ECOG performance status 0-1
- Hematopoietic: WBC at least 4,000/mm^3; Platelet count at least 100,000/mm^3
- Hepatic: Bilirubin normal; AST/ALT no greater than 1.5 times upper limit of normal (ULN); Alkaline phosphatase no greater than 2.5 times ULN
- Renal: Creatinine clearance greater than 60 ml/min
- Cardiovascular: Cardiac function normal
Who cannot join
- Severe complications or infections
- Pregnant or breast-feeding women
- Clinically significant heart disease
- Uncontrolled hepatitis, chronic liver disease, or diabetes mellitus
- Another active cancer except properly treated carcinoma in situ of the cervix or basal/squamous cell skin carcinoma
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Cardiothoracic Surgery, the First Affiliated Hospital of Guangzhou Medical College
Guangzhou, Guangdong, 510120
About this study
Official title: Feasibility of Assisted-VATS(Video-Assisted Thoracoscopic Surgery) Sleeve Lobectomy for Non-small Cell Lung Cancer
The purpose of this study is to examine the feasibility of assisted-VATS (video-assisted thoracoscopic surgery) sleeve lobectomy for non-small cell lung cancer for non-small cell lung cancer. Success is defined as assisted-VATS sleeve lobectomy without conversion. If success rate over 90%, assisted-VATS sleeve lobectomy is considered as feasible procedures for non-small cell lung cancer.
Read the detailed description
Sleeve lobectomy is removal of a portion of a main stem bronchus in continuity with the adjacent lobe or bilobe followed by end-to-end bronchial anastomosis. The first reported bronchial sleeve resection was performed in 1947 at the Brompton Hospital in London, England, by Sir Clement Price Thomas. Whether sleeve resection is radical enough and indicated for patients who could tolerate pneumonectomy continues to be debated, although many recent reports have suggested that sleeve resection can achieve adequate curability rates. However, sleeve lobectomy has a definite role in the surgical management of lung cancer for patients whose pulmonary reserve is considered inadequate to permit pneumonectomy, and should be used anytime it is possible to achieve a margin-negative (R0) resection.
Although video-assisted thoracic surgery (VATS) is regarded as a minimally invasive procedure with good long-term survival results, many surgeons think that VATS is too complex and has too many technical limitations to be applied to bronchoplasty. Therefore, there are few reports in the literature of VATS bronchoplasty for lung cancer. The purpose of this study is to examine the feasibility of assisted-VATS (video-assisted thoracoscopic surgery) sleeve lobectomy for non-small cell lung cancer for non-small cell lung cancer. Success is defined as assisted-VATS sleeve lobectomy without conversion. If success rate over 90%, assisted-VATS sleeve lobectomy is considered as feasible procedures for non-small cell lung cancer.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- a-VATS
- Keywords
- assisted-VATS (video-assisted thoracoscopic surgery), sleeve lobectomy, bronchoplasty
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a-VATSProcedure or surgery
Also called assisted-VATS (video-assisted thoracoscopic surgery)
In brief, general anesthesia with selective lung ventilation was performed with the use of a double-lumen endotracheal tube. When postoperative mechanical ventilation was necessary, a standard endotracheal tube was substituted for the double-lumen tube. Patients were placed in the lateral decubitus position. Two thoracoports were placed in the sixth or seventh intercostal space (ICS) on the anterior axillary line and in the seventh or eighth ICS on the posterior axillary line; an anterolateral minithoracotomy (7 cm) was made in the fourth ICS for an upper lobectomy or in the fifth ICS for a middle or lower lobectomy.
| Study group | Role | What they receive |
|---|---|---|
| a-VATS | Experimental | Patients with NSCLC underwent assisted-VATS sleeve lobectomy with bronchoplasty. Receives: Procedure: a-VATS |
What is being measured
The primary outcome is the main question the study is designed to answer.
If success rate over 90%, assisted-VATS sleeve lobectomy is considered as feasible procedures for non-small cell lung cancer. (Success is defined as assisted-VATS sleeve lobectomy without conversion).
Measured: 3 months
Secondary outcomes (1)
To evaluate the intraoperative(surgical duration, estimated blood loss), postoperative variables(mortality, morbidity, chest tube drainage duration, hospital stay), and 5-year survival rates.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2009 (estimated)
- Study startFeb 1996
- Primary completionJan 2010 (estimated)
- Study completionJan 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Guangzhou Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Investigators
- Jianxing He, MD,FACS, Study director, Department of Cardiothoracic Surgery, the First Affiliated Hospital of Guangzhou Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00997724
- Sponsor's protocol ID
- FAHG96016
- Acronym
- VATS
- Status last verified
- Oct 2009
- First submitted
- 18 Oct 2009
- Last updated
- 5 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
He J, Shao W, Cao C, Yan TD, Wang D, Xiong X, Yin W, Xu X, Huang J. Long-term outcome of hybrid surgical approach of video-assisted minithoracotomy sleeve lobectomy for non-small-cell lung cancer. Surg Endosc. 2011 Aug;25(8):2509-15. doi: 10.1007/s00464-011-1576-6. Epub 2011 Feb 7.
PubMed 21298520
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Assisted-VATS(Video-Assisted Thoracoscopic Surgery) Sleeve Lobectomy for Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00997724
- Acronym / sponsor ID
- VATS / FAHG96016
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- assisted-VATS (video-assisted thoracoscopic surgery), sleeve lobectomy, bronchoplasty
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- Feb 1996
- Primary completion
- Jan 2010 (estimated)
- Study completion
- Jan 2011 (estimated)
- First posted
- 19 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the feasibility of assisted-VATS (video-assisted thoracoscopic surgery) sleeve lobectomy for non-small cell lung cancer for non-small cell lung cancer. Success is defined as assisted-VATS sleeve lobectomy without conversion. If success rate over 90%, assisted-VATS sleeve lobectomy is considered as feasible procedures for non-small cell lung cancer.
Detailed description
Sleeve lobectomy is removal of a portion of a main stem bronchus in continuity with the adjacent lobe or bilobe followed by end-to-end bronchial anastomosis. The first reported bronchial sleeve resection was performed in 1947 at the Brompton Hospital in London, England, by Sir Clement Price Thomas. Whether sleeve resection is radical enough and indicated for patients who could tolerate pneumonectomy continues to be debated, although many recent reports have suggested that sleeve resection can achieve adequate curability rates. However, sleeve lobectomy has a definite role in the surgical management of lung cancer for patients whose pulmonary reserve is considered inadequate to permit pneumonectomy, and should be used anytime it is possible to achieve a margin-negative (R0) resection.
Although video-assisted thoracic surgery (VATS) is regarded as a minimally invasive procedure with good long-term survival results, many surgeons think that VATS is too complex and has too many technical limitations to be applied to bronchoplasty. Therefore, there are few reports in the literature of VATS bronchoplasty for lung cancer. The purpose of this study is to examine the feasibility of assisted-VATS (video-assisted thoracoscopic surgery) sleeve lobectomy for non-small cell lung cancer for non-small cell lung cancer. Success is defined as assisted-VATS sleeve lobectomy without conversion. If success rate over 90%, assisted-VATS sleeve lobectomy is considered as feasible procedures for non-small cell lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| a-VATS | Experimental | Procedure: a-VATSPatients with NSCLC underwent assisted-VATS sleeve lobectomy with bronchoplasty. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically confirmed non-small cell lung cancer (Squamous, adenosquamous, large cell, or poorly differentiated)
- Patients with central tumors located at the origin of a lobar bronchus.
- ECOG performance status 0-1
- Hematopoietic: WBC at least 4,000/mm^3; Platelet count at least 100,000/mm^3
- Hepatic: Bilirubin normal; AST/ALT no greater than 1.5 times upper limit of normal (ULN); Alkaline phosphatase no greater than 2.5 times ULN
Key exclusion criteria (5 listed)
- Severe complications or infections
- Pregnant or breast-feeding women
- Clinically significant heart disease
- Uncontrolled hepatitis, chronic liver disease, or diabetes mellitus
- Another active cancer except properly treated carcinoma in situ of the cervix or basal/squamous cell skin carcinoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| a-VATSAlso: assisted-VATS (video-assisted thoracoscopic surgery)In brief, general anesthesia with selective lung ventilation was performed with the use of a double-lumen endotracheal tube. When postoperative mechanical ventilation was necessary, a standard endotracheal tube was substituted for the double-lumen tube. Patients were placed in the lateral decubitus position. Two thoracoports were placed in the sixth or seventh intercostal space (ICS) on the anterior axillary line and in the seventh or eighth ICS on the posterior axillary line; an anterolateral minithoracotomy (7 cm) was made in the fourth ICS for an upper lobectomy or in the fifth ICS for a middle or lower lobectomy. | Procedure or surgery | a-VATS |
Primary outcome
If success rate over 90%, assisted-VATS sleeve lobectomy is considered as feasible procedures for non-small cell lung cancer. (Success is defined as assisted-VATS sleeve lobectomy without conversion).
Time frame: 3 months
1 secondary outcome
To evaluate the intraoperative(surgical duration, estimated blood loss), postoperative variables(mortality, morbidity, chest tube drainage duration, hospital stay), and 5-year survival rates.
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2010.
- Derived from this study: PubMed 21298520He J, Shao W, Cao C, Yan TD, Wang D, Xiong X, Yin W, Xu X, Huang J. Long-term outcome of hybrid surgical approach of video-assisted minithoracotomy sleeve lobectomy for non-small-cell lung cancer. Surg Endosc. 2011 Aug;25(8):2509-15. doi: 10.1007/s00464-011-1576-6. Epub 2011 Feb 7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianxing He, MD,FACS study director
Department of Cardiothoracic Surgery, the First Affiliated Hospital of Guangzhou Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing a-VATS in people with Non-small Cell Lung Cancer, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
If success rate over 90%, assisted-VATS sleeve lobectomy is considered as feasible procedures for non-small cell lung cancer. (Success is defined as assisted-VATS sleeve lobectomy without conversion). (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00997724, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2010.