Lung DiseasesNCT05270616
Robotic Versus Video-assisted Lobectomy/Segmentectomy for Lung Surgery
A study testing robotic surgery, uniport surgery and multiple- port surgery in people with Lung Diseases and Surgery, run by The Second Hospital of Shandong University at 1 site in China.
Trial summary
To compare the safety/efficacy of the robotic-assisted lobectomy/segmentectomy (RAL/S) with the video-assisted lobectomy/segmentectomy (VAL/S) for lung resection. Video-assisted lobectomy/segmentectomy (VAL/S) for lung resection is divided into uniport group and multiple- port group. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Lung Diseases, Surgery
- What is being tested?
- robotic surgery, uniport surgery and multiple- port surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2020to 1 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- good cardio- pulmonary function to tolerate surgery;
- minimaly invasive surgery for lobectomy or segmentectomy or sleeve lobectomy;
Who cannot join
- cardio- pulmonary function is not good enough to tolerate surgery;
- huge tumor or extensive adhesion in thoracic cavity.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Hospital of Shandong University
Jinan, Shandong, 250033
Yunpeng Zhao, doctor, +8618766188692
About this study
To compare the safety/efficacy of the robotic-assisted lobectomy/segmentectomy (RAL/S) with the video-assisted lobectomy/segmentectomy (VAL/S) for lung resection.
Video-assisted lobectomy/segmentectomy (VAL/S) for lung resection is divided into uniport group and multiple- port group.
- Conditions
- Lung Diseases, Surgery
- Being tested
- robotic surgery, uniport surgery, multiple- port surgery
- Keywords
- robotic surgery, VATS, uniport, multiport
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
robotic surgeryProcedure or surgery
minimally invasive surgery using the Davinci robotic system
uniport surgeryProcedure or surgery
VATS minimally invasive surgery under the uniportal status
multiple- port surgeryProcedure or surgery
VATS minimally invasive surgery under the multiple- port status
| Study group | Role | What they receive |
|---|---|---|
| robotic surgery group | Experimental | minimally invasive lung surgery using the Davinci robotic system to assist. Receives: Procedure: robotic surgery |
| uniport surgery group | Active comparator | VATS minimally invasive lung surgery under the uniportal status. Receives: Procedure: uniport surgery |
| multiple- port surgery group | Active comparator | VATS minimally invasive lung surgery under the multiple- port status. Receives: Procedure: multiple- port surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
incidence rate
Measured: 30 days after surgery
conversion rate to open surgery
incidence rate
Measured: during surgery
postoperative complications
incidence rate
Measured: within 7 days after surgery
operation time
minutes
Measured: within 180 minutes
duration of hospitalization
days
Measured: within 7 days after surgery
days to tube removal
days
Measured: within 7 days after surgery
retrieved lymph node
amount
Measured: within 1 days after surgery
retrieved lymph node station
amount
Measured: within 1 days after surgery
short- term PFS
proportion
Measured: 3 years
short- term overall survival
proportion
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start1 Jun 2020
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung DiseasesStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05270616
- Sponsor's protocol ID
- Robotic lung ZYP
- Status last verified
- Feb 2022
- First submitted
- 27 Feb 2022
- Last updated
- 8 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic Versus Video-assisted Lobectomy/Segmentectomy for Lung Surgery
- ClinicalTrials.gov ID
- NCT05270616
- Acronym / sponsor ID
- Robotic lung ZYP
- Conditions
- Lung Diseases, Surgery
- Keywords
- robotic surgery, VATS, uniport, multiport
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- The Second Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 8 Mar 2022 (actual)
- 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.
To compare the safety/efficacy of the robotic-assisted lobectomy/segmentectomy (RAL/S) with the video-assisted lobectomy/segmentectomy (VAL/S) for lung resection.
Video-assisted lobectomy/segmentectomy (VAL/S) for lung resection is divided into uniport group and multiple- port group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| robotic surgery group | Experimental | Procedure: robotic surgeryminimally invasive lung surgery using the Davinci robotic system to assist. |
| uniport surgery group | Active comparator | Procedure: uniport surgeryVATS minimally invasive lung surgery under the uniportal status. |
| multiple- port surgery group | Active comparator | Procedure: multiple- port surgeryVATS minimally invasive lung surgery under the multiple- port status. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- good cardio- pulmonary function to tolerate surgery;
- minimaly invasive surgery for lobectomy or segmentectomy or sleeve lobectomy;
Key exclusion criteria (2 listed)
- cardio- pulmonary function is not good enough to tolerate surgery;
- huge tumor or extensive adhesion in thoracic cavity.
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 |
|---|---|---|
| robotic surgeryminimally invasive surgery using the Davinci robotic system | Procedure or surgery | robotic surgery group |
| uniport surgeryVATS minimally invasive surgery under the uniportal status | Procedure or surgery | uniport surgery group |
| multiple- port surgeryVATS minimally invasive surgery under the multiple- port status | Procedure or surgery | multiple- port surgery group |
Primary outcome
mortality
Time frame: 30 days after surgery
incidence rate
conversion rate to open surgery
Time frame: during surgery
incidence rate
postoperative complications
Time frame: within 7 days after surgery
incidence rate
operation time
Time frame: within 180 minutes
minutes
duration of hospitalization
Time frame: within 7 days after surgery
days
days to tube removal
Time frame: within 7 days after surgery
days
retrieved lymph node
Time frame: within 1 days after surgery
amount
retrieved lymph node station
Time frame: within 1 days after surgery
amount
short- term PFS
Time frame: 3 years
proportion
short- term overall survival
Time frame: 3 years
proportion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing robotic surgery, uniport surgery and multiple- port surgery in people with Lung Diseases and Surgery, run by The Second Hospital of Shandong 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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 8 Mar 2022. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaogang Zhao (+8617660080007, zhaoxiaogang@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality (time frame: 30 days after surgery). The study lists 10 primary outcomes in all. 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 8 Mar 2022.