Lung NeoplasmsNCT02933294
Uniportal Versus Triportal Thoracoscopic Lobectomy and Sublobectomy for Early Stage Lung Cancer
A study testing Triportal pulmonary resection surgery and Uniportal pulmonary resection surgery in people with Lung Neoplasms, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 4 sites in China.
Trial summary
Lung cancer is one of the most common cancers in the world. At present, surgical resection is still the standard treatment for early stage lung cancer. Triportal thoracoscopic lung resection is a routine surgically procedure for early stage lung cancer while uniportal thoracoscopic lung resection is developing rapidly… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Neoplasms
- What is being tested?
- Triportal pulmonary resection surgery and Uniportal pulmonary resection surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 356 participants
- Where
- 4 sitesChina
- Study dates
- May 2015to Dec 2020
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age≥18 years;
- cT1- 2N0-1M0 diagnosed by chest CT, PET-CT before operation;
- No severe comorbidity, can tolerate anesthesia;
- ECOG PS scores≤2;
- The patients sign informed consents by themselves.
Who cannot join
- Inability to tolerance of tracheal intubation and general anesthesia;
- ECOG PS scores>2;
- Severe comorbidities including: Angina occurs in 3 months, uncontrolled hypertension, Congestive heart failure, a history of myocardial infarction in 6 months before admission, severe arrhythmia, severe liver, kidney or other metabolic diseases.
Trial locations and contacts
4 sites in 1 country.
China4 sites, 4 recruiting
- Recruiting
Beijing Chest Hospital
Beijing, 110000
Zhidong Liu, MD
- Recruiting
Chinese PLA General Hospital
Beijing, 110000
Yang Liu, MD
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 518000
Lanjun Zhang, MD
- Recruiting
Fudan University Cancer Center
Shanghai, 200000
Jiaqing Xiang, MD
About this study
Official title: Uniportal Versus Triportal Thoracoscopic Lobectomy and Sublobectomy for Early Stage Lung Cancer: a Multicenter Randomized Controlled Trial
Lung cancer is one of the most common cancers in the world. At present, surgical resection is still the standard treatment for early stage lung cancer. Triportal thoracoscopic lung resection is a routine surgically procedure for early stage lung cancer while uniportal thoracoscopic lung resection is developing rapidly in recent years. Although uniportal VATS pulmonary resection has been proven to be effective in preventing postoperative morbidities, there is still no ample evidences to demonstrate that uniportal VATS pulmonary resection is equal or superior to traditional triportal thoracoscopic pulmonary resection. The purpose of this multicenter randomized controlled trial study is to compare the uniportal VATS with traditional triportal VATS pulmonary resection in postoperative complications, long-term survival, lymph node dissection and local recurrence.
Read the detailed description
Lung cancer is one of the most common cancers in the world，especially in China, where the mortality ranked first in malignant tumors whether for males or females. At present, VATS (Video-assisted thoracoscopic surgery) lobectomy is still the "gold standard" for the treatment of lung cancer. Triportal thoracoscopic lung resection is a routine surgically procedure for early stage lung cancer while uniportal thoracoscopic lung resection is developing rapidly in recent years. Retrospective study in recent years showed that the postoperative complication rate is similar between uniportal thoracoscopic surgery and triportal thoracoscopic surgery. Meanwhile, the incision is more pleasing, the inflammatory response may be milder and the hospitalization time may be shorter in the uniportal thoracoscopic surgery. But until now there is no result of the randomized controlled study on the effectiveness and the prognosis between uniportal thoracoscopic surgery and triportal thoracoscopic surgery to support this conclusion. The objective of this multicenter randomized controlled trial study is to compare the postoperative complications, long-term survival, local recurrence, other perioperative variables such as conversion rate, blood loss, lymph nodes retrieved and postoperative hospital stay between the triportal VATS pulmonary resection and uniportal VATS pulmonary resection on early stage lung cancer.
- Conditions
- Lung Neoplasms
- Being tested
- Triportal pulmonary resection surgery, Uniportal pulmonary resection surgery
- Keywords
- uniportal, lung cancer, VATS
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triportal pulmonary resection surgeryProcedure or surgery
Uniportal video-assisted thoracoscopic surgery
Uniportal pulmonary resection surgeryProcedure or surgery
Triportal video-assisted thoracoscopic surgery
| Study group | Role | What they receive |
|---|---|---|
| Triportal pulmonary resection surgery | Active comparator | Treated by traditional video assisted thoracoscopic three-port pulmonary resection in the centers with enough experience in VATS and the volume ≧50 cases each year. Receives: Procedure: Triportal pulmonary resection surgery |
| Uniportal pulmonary resection surgery | Active comparator | Treated by minimally invasive video assisted thoracoscopic single-port pulmonary resection in the centers with enough experience in VATS and the volume ≧50 cases each year. Receives: Procedure: Uniportal pulmonary resection surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative respiratory complications
These respiratory complications involve respiratory distress or failure after the operation with continuation of mechanical ventilation, pulmonary atelectasis requiring sputum suction by bronchoscopy, pneumonia requiring specific antibiotics confirmed by thoracic X-ray or CT scan of the thorax and a positive sputum culture, and acute respiratory distress syndrome.
Measured: 30 days after surgery
Secondary outcomes (5)
Blood loss
blood loss during the surgery
Measured: Intraoperation
Lymph node dissection
During the surgery, lymph node dissection were performed. The number of removed lymph-nodes were recorded according to the postoperative pathological diagnosis, and the stations of the lymph node were recorded according to the International Association for the Study of Lung Cancer (IASLC) Lymph Node Map.
Measured: Intraoperation
Long term survival
five-year survival rates after surgery
Measured: 5 year
Local recurrence
three-year local recurrence rate after surgery
Measured: 3 years
Conversion rate
conversion to thoracotomy during surgery
Measured: Intraoperation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2016 (estimated)
- Study startMay 2015
- Primary completionApr 2018 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NeoplasmsStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 356 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Sun Yat-sen University, Fudan University, Chinese PLA General Hospital, Beijing Chest Hospital
- Responsible party
- Principal investigator, Ju-Wei Mu, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Investigators
- Juwei Mu, MD, Principal investigator, Collaborative Innovation Center for Cancer Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02933294
- Sponsor's protocol ID
- ZLYXXTCX-201509
- Status last verified
- Oct 2016
- First submitted
- 23 Sep 2016
- Last updated
- 14 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uniportal Versus Triportal Thoracoscopic Lobectomy and Sublobectomy for Early Stage Lung Cancer: a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02933294
- Acronym / sponsor ID
- ZLYXXTCX-201509
- Conditions
- Lung Neoplasms
- Keywords
- uniportal, lung cancer, VATS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 356 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- Sun Yat-sen University, Fudan University, Chinese PLA General Hospital, Beijing Chest Hospital
- Study start
- May 2015
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 14 Oct 2016 (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.
Lung cancer is one of the most common cancers in the world. At present, surgical resection is still the standard treatment for early stage lung cancer. Triportal thoracoscopic lung resection is a routine surgically procedure for early stage lung cancer while uniportal thoracoscopic lung resection is developing rapidly in recent years. Although uniportal VATS pulmonary resection has been proven to be effective in preventing postoperative morbidities, there is still no ample evidences to demonstrate that uniportal VATS pulmonary resection is equal or superior to traditional triportal thoracoscopic pulmonary resection. The purpose of this multicenter randomized controlled trial study is to compare the uniportal VATS with traditional triportal VATS pulmonary resection in postoperative complications, long-term survival, lymph node dissection and local recurrence.
Detailed description
Lung cancer is one of the most common cancers in the world，especially in China, where the mortality ranked first in malignant tumors whether for males or females. At present, VATS (Video-assisted thoracoscopic surgery) lobectomy is still the "gold standard" for the treatment of lung cancer. Triportal thoracoscopic lung resection is a routine surgically procedure for early stage lung cancer while uniportal thoracoscopic lung resection is developing rapidly in recent years. Retrospective study in recent years showed that the postoperative complication rate is similar between uniportal thoracoscopic surgery and triportal thoracoscopic surgery. Meanwhile, the incision is more pleasing, the inflammatory response may be milder and the hospitalization time may be shorter in the uniportal thoracoscopic surgery. But until now there is no result of the randomized controlled study on the effectiveness and the prognosis between uniportal thoracoscopic surgery and triportal thoracoscopic surgery to support this conclusion. The objective of this multicenter randomized controlled trial study is to compare the postoperative complications, long-term survival, local recurrence, other perioperative variables such as conversion rate, blood loss, lymph nodes retrieved and postoperative hospital stay between the triportal VATS pulmonary resection and uniportal VATS pulmonary resection on early stage lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Triportal pulmonary resection surgery | Active comparator | Procedure: Triportal pulmonary resection surgeryTreated by traditional video assisted thoracoscopic three-port pulmonary resection in the centers with enough experience in VATS and the volume ≧50 cases each year. |
| Uniportal pulmonary resection surgery | Active comparator | Procedure: Uniportal pulmonary resection surgeryTreated by minimally invasive video assisted thoracoscopic single-port pulmonary resection in the centers with enough experience in VATS and the volume ≧50 cases each year. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age≥18 years;
- cT1- 2N0-1M0 diagnosed by chest CT, PET-CT before operation;
- No severe comorbidity, can tolerate anesthesia;
- ECOG PS scores≤2;
- The patients sign informed consents by themselves.
Key exclusion criteria (3 listed)
- Inability to tolerance of tracheal intubation and general anesthesia;
- ECOG PS scores>2;
- Severe comorbidities including: Angina occurs in 3 months, uncontrolled hypertension, Congestive heart failure, a history of myocardial infarction in 6 months before admission, severe arrhythmia, severe liver, kidney or other metabolic diseases.
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 |
|---|---|---|
| Triportal pulmonary resection surgeryUniportal video-assisted thoracoscopic surgery | Procedure or surgery | Triportal pulmonary resection surgery |
| Uniportal pulmonary resection surgeryTriportal video-assisted thoracoscopic surgery | Procedure or surgery | Uniportal pulmonary resection surgery |
Primary outcome
Postoperative respiratory complications
Time frame: 30 days after surgery
These respiratory complications involve respiratory distress or failure after the operation with continuation of mechanical ventilation, pulmonary atelectasis requiring sputum suction by bronchoscopy, pneumonia requiring specific antibiotics confirmed by thoracic X-ray or CT scan of the thorax and a positive sputum culture, and acute respiratory distress syndrome.
5 secondary outcomes
Blood loss
Time frame: Intraoperation
Lymph node dissection
Time frame: Intraoperation
Long term survival
Time frame: 5 year
Local recurrence
Time frame: 3 years
Conversion rate
Time frame: Intraoperation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2016.
- Individual participant dataSharing planned: Undecided
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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.
Juwei Mu, MD principal investigator
Collaborative Innovation Center for Cancer Medicine
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Triportal pulmonary resection surgery and Uniportal pulmonary resection surgery in people with Lung Neoplasms, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 4 sites 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 5 inclusion and 3 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 14 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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.
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?
Contact Juwei Mu, MD (8610-87788495 ext. 7140, mujuwei@cicams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative respiratory complications (time frame: 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Oct 2016.