RoboticsSPORTSNCT06202690
SP Robotic Versus VATS Anatomical Pulmonary Resection for Patients With NSCLC
A study testing Single-port robotic-assisted thoracic surgery and Single-port video-assisted thoracoscopic surgery in people with Robotics and Lung Cancer, run by Korea University Guro Hospital.
Trial summary
Single-POrt Robotic-assisted thoracic surgery versus single-port video-assisted Thoracic Surgery major pulmonary resection for patients with non-small cell lung cancer (SPORTS trial): a single-center, a single blinded, randomized controlled trial Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Robotics, Lung Cancer
- What is being tested?
- Single-port robotic-assisted thoracic surgery and Single-port video-assisted thoracoscopic surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 290 participants
- Where
- No sites listed yet
- Study dates
- 9 Jan 2024to 30 Jun 2031
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Candidate for anatomical pulmonary resection (segmentectomy or lobectomy) via minimally invasive thoracic surgery (RATS or VATS) for patient with non-small cell lung cancer or suspected malignant lesion.
- Age ≥ 18 years
- Patients who can comply with the requirements of the clinical trial and who, or their legal representatives, provide written consent before the start of the clinical trial
- Patients with the nationality of South Korea
- American Society of Anesthesiologists score 1-3.
- Clinical stage I, II or IIIa non-small cell lung cancer (NSCLC)
Who cannot join
- Patients who require surgery for accompanying other organ diseases
- Tumor invasion into the chest wall, diaphragm, another lobe or diaphragm
- Patients who are considered unsuitable based on the researcher's judgment
- Patients with cognitive impairments who are unable to understand the instructions and informed consent of this study
- Patients who specifically desire a certain surgical method (robotic, thoracoscopic, open thoracotomy)
- Patients who previously undergone a thoracic surgical procedure in the hemithorax to be operated on
Show all 10Show fewer
- Pathological results other than NSCLC (ex, benign nodules, metastatic lung cancer, SCLC)
- Patients who received neoadjuvant therapy.
- Candidate for pneumonectomy, bilobectomy, lobectomy plus segmentectomy, non-anatomic resection (ex, wedge resection).
- History of other cancers in the past 5 years.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Single-POrt Robotic Versus Video-assisted Thoracic Surgery Anatomical Pulmonary Resection for Patients With Non-small Cell Lung Cancer (SPORTS Study): a Single-center, Single-blinded, Randomized Controlled Trial
Single-POrt Robotic-assisted thoracic surgery versus single-port video-assisted Thoracic Surgery major pulmonary resection for patients with non-small cell lung cancer (SPORTS trial): a single-center, a single blinded, randomized controlled trial
Read the detailed description
Investigators initially began single-port robotic thoracic surgery using the SP robotic system for simple procedures, such as thymectomy and mediastinal mass excision. As their expertise grew, they expanded to more complex procedures, including major pulmonary resection and esophagectomy. However, the long-term outcomes of SP robotic anatomical pulmonary resection using the SP robotic system have not yet been studied.
The aim of this study is to compare the short-term and long-term outcomes of SP robotic anatomical pulmonary resection using the SP robotic system with those of single-port video-assisted thoracoscopic surgery (SP-VATS) anatomical pulmonary resection.
This trial is a single-center, single-blinded, randomized controlled trial. Participants will be randomized at a 1:1 ratio to either single-port video-assisted thoracoscopic surgery (SP-VATS) or single-port robotic thoracic surgery.
- Conditions
- Robotics, Lung Cancer
- Being tested
- Single-port robotic-assisted thoracic surgery, Single-port video-assisted thoracoscopic surgery
- Keywords
- sing-port surgery, robotic-assisted thoracic surgery, lung cancer
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-port robotic-assisted thoracic surgeryProcedure or surgery
Also called SP-RATS
All patients : 145 patients Single-port anatomical pulmonary resection(segmentectomy, lobectomy) with a complete mediastinal lymph node dissection will be performed using the SP robotic system.
A 4-cm single incision will be made below the subcostal margin. A chest tube will be inserted in same incision.
Single-port video-assisted thoracoscopic surgeryProcedure or surgery
Also called SP-VATS
All patients : 145 patients Single-port anatomical pulmonary resection(segmentectomy, lobectomy) with a complete mediastinal lymph node dissection will be performed using the VATS.
A 4-cm single incision will be made at 5th intercostal space. A chest tube will be inserted in same incision.
| Study group | Role | What they receive |
|---|---|---|
| SP-RATS | Active comparator | SP-RATS Arm: 145 patients, single-port anatomical pulmonary resection will be performed using the SP robotic system. A 4-cm single incision will be made below the subcostal margin. A chest tube will be inserted in same incision. Receives: Procedure: Single-port robotic-assisted thoracic surgery |
| SP-VATS | Placebo comparator | SP-VATS Arm: 145 patients, single-port anatomical pulmonary resection was performed using VATS. A 4-cm incision will be made at 5th intercostal space on the anterior or posterior axillary line. A chest tube will be inserted in same incision. Receives: Procedure: Single-port video-assisted thoracoscopic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complications
complications will be classified according to Clavien-Dindo classfication
Measured: Postoperative complications : within 30 days after surgery
Questionnaires for HRQOL of life (EQ-5D-5L) at month 3
Questionnaires for HRQOL of life (EQ-5D-5L) will be administered at months 3.
Measured: at month 3 after surgery
Questionnaires for HRQOL of life (EQ-VAS) at month 3
Questionnaires for HRQOL of life (EQ-5D-5L, EQ-VAS) will be administered at months 3.
Measured: at month 3 after surgery
Postoperative pain
Pain levels were assessed and recorded using the VAS score more than three times daily during the hospitalization period.
Measured: during hospitalization
Secondary outcomes (10)
Questionnaires for HRQOL of life (EQ-5D-5L)
Questionnaires for HRQOL of life (EQ-5D-5L, EQ-VAS) will be administered at 2 weeks before surgery, and at 1 month, 6 months, and 12 months, as well as at years 2, 3, 4, and 5 after surgery.
Measured: At 2 weeks before surgery, and at 1 month, 6 months, and 12 months, as well as at years 2, 3, 4, and 5 after surgery.
Questionnaires for HRQOL of life (EQ-VAS)
Questionnaires for HRQOL of life (EQ-5D-5L, EQ-VAS) will be administered at 2 weeks before surgery, and at 1 month, 6 months, and 12 months, as well as at years 2, 3, 4, and 5 after surgery.
Measured: At 2 weeks before surgery, and at 1 month, 6 months, and 12 months, as well as at years 2, 3, 4, and 5 after surgery.
Questionnaires for HRQOL of life (LCQ)
Questionnaires for HRQOL of life (LCQ) will be administered at 1 month, 3 months, and 6 months after surgery.
Measured: at 1 month, 3 months, and 6 months after surgery.
Perioperative outcomes (Conversion rate)
Conversion rate = conversion to open thoracotomy / total number of surgery
Measured: during hospitalization
Perioperative outcomes (number of lymph nodes harvested)
Total number of lymph nodes harvested during the surgical procedure.
Measured: during hospitalization
Perioperative outcomes (total operative time)
the time taken from skin incision to completion of skin closure
Measured: during hospitalization
Perioperative outcomes (duration of chest tube drainage, postoperative hospital stays)
duration of chest tube drainage: the time from the date of the operation to the date of chest tube removal
postoperative hospital stays: the time from the date of the operation to the date of discharge
Measured: during hospitalization
Perioperative outcomes (transfusion rate)
The transfusion rate was defined as the percentage of patients who received an allogeneic blood transfusion within 30 days after surgery.
Measured: within 30 days after surgery.
Perioperative outcomes (estimated blood loss )
estimated measurement of intraoperative blood loss (ml)
Measured: during surgery
5-year overall survival and disease-free survival
Overall survival (OS) is defined as the time from randomization to death. Disease-free survival (DFS) is defined as the time from randomization to recurrence of tumor or death.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start9 Jan 2024 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RoboticsStudies 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
- Model description
- This trial is a single-center, single blinded, randomized controlled trial). Participants will be randomized in a 1:1 ratio to either to single-port video-assisted thoracoscopic surgery (SP-VATS) or single-port robotic-assisted thoracic surgery (SP-RATS).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 290 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea University Guro Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyun Koo Kim, Korea University Guro Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06202690
- Sponsor's protocol ID
- 2023GR0429
- Acronym
- SPORTS
- Status last verified
- Jan 2024
- First submitted
- 9 Nov 2023
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-POrt Robotic Versus Video-assisted Thoracic Surgery Anatomical Pulmonary Resection for Patients With Non-small Cell Lung Cancer (SPORTS Study): a Single-center, Single-blinded, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06202690
- Acronym / sponsor ID
- SPORTS / 2023GR0429
- Conditions
- Robotics, Lung Cancer
- Keywords
- sing-port surgery, robotic-assisted thoracic surgery, lung cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 290 participants (estimated)
- Lead sponsor
- Korea University Guro HospitalUniversity, hospital or other
- Study start
- 9 Jan 2024 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2031 (estimated)
- First posted
- 11 Jan 2024 (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.
Single-POrt Robotic-assisted thoracic surgery versus single-port video-assisted Thoracic Surgery major pulmonary resection for patients with non-small cell lung cancer (SPORTS trial): a single-center, a single blinded, randomized controlled trial
Detailed description
Investigators initially began single-port robotic thoracic surgery using the SP robotic system for simple procedures, such as thymectomy and mediastinal mass excision. As their expertise grew, they expanded to more complex procedures, including major pulmonary resection and esophagectomy. However, the long-term outcomes of SP robotic anatomical pulmonary resection using the SP robotic system have not yet been studied.
The aim of this study is to compare the short-term and long-term outcomes of SP robotic anatomical pulmonary resection using the SP robotic system with those of single-port video-assisted thoracoscopic surgery (SP-VATS) anatomical pulmonary resection.
This trial is a single-center, single-blinded, randomized controlled trial. Participants will be randomized at a 1:1 ratio to either single-port video-assisted thoracoscopic surgery (SP-VATS) or single-port robotic thoracic surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This trial is a single-center, single blinded, randomized controlled trial). Participants will be randomized in a 1:1 ratio to either to single-port video-assisted thoracoscopic surgery (SP-VATS) or single-port robotic-assisted thoracic surgery (SP-RATS).
| Arm | Type | Receives |
|---|---|---|
| SP-RATS | Active comparator | Procedure: Single-port robotic-assisted thoracic surgerySP-RATS Arm: 145 patients, single-port anatomical pulmonary resection will be performed using the SP robotic system. A 4-cm single incision will be made below the subcostal margin. A chest tube will be inserted in same incision. |
| SP-VATS | Placebo comparator | Procedure: Single-port video-assisted thoracoscopic surgerySP-VATS Arm: 145 patients, single-port anatomical pulmonary resection was performed using VATS. A 4-cm incision will be made at 5th intercostal space on the anterior or posterior axillary line. A chest tube will be inserted in same incision. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Candidate for anatomical pulmonary resection (segmentectomy or lobectomy) via minimally invasive thoracic surgery (RATS or VATS) for patient with non-small cell lung cancer or suspected malignant lesion.
- Age ≥ 18 years
- Patients who can comply with the requirements of the clinical trial and who, or their legal representatives, provide written consent before the start of the clinical trial
- Patients with the nationality of South Korea
- American Society of Anesthesiologists score 1-3.
Key exclusion criteria (10 listed)
- Patients who require surgery for accompanying other organ diseases
- Tumor invasion into the chest wall, diaphragm, another lobe or diaphragm
- Patients who are considered unsuitable based on the researcher's judgment
- Patients with cognitive impairments who are unable to understand the instructions and informed consent of this study
- Patients who specifically desire a certain surgical method (robotic, thoracoscopic, open thoracotomy)
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 |
|---|---|---|
| Single-port robotic-assisted thoracic surgeryAlso: SP-RATSAll patients : 145 patients Single-port anatomical pulmonary resection(segmentectomy, lobectomy) with a complete mediastinal lymph node dissection will be performed using the SP robotic system. A 4-cm single incision will be made below the subcostal margin. A chest tube will be inserted in same incision. | Procedure or surgery | SP-RATS |
| Single-port video-assisted thoracoscopic surgeryAlso: SP-VATSAll patients : 145 patients Single-port anatomical pulmonary resection(segmentectomy, lobectomy) with a complete mediastinal lymph node dissection will be performed using the VATS. A 4-cm single incision will be made at 5th intercostal space. A chest tube will be inserted in same incision. | Procedure or surgery | SP-VATS |
Primary outcome
Postoperative complications
Time frame: Postoperative complications : within 30 days after surgery
complications will be classified according to Clavien-Dindo classfication
Questionnaires for HRQOL of life (EQ-5D-5L) at month 3
Time frame: at month 3 after surgery
Questionnaires for HRQOL of life (EQ-5D-5L) will be administered at months 3.
Questionnaires for HRQOL of life (EQ-VAS) at month 3
Time frame: at month 3 after surgery
Questionnaires for HRQOL of life (EQ-5D-5L, EQ-VAS) will be administered at months 3.
Postoperative pain
Time frame: during hospitalization
Pain levels were assessed and recorded using the VAS score more than three times daily during the hospitalization period.
10 secondary outcomes
Questionnaires for HRQOL of life (EQ-5D-5L)
Time frame: At 2 weeks before surgery, and at 1 month, 6 months, and 12 months, as well as at years 2, 3, 4, and 5 after surgery.
Questionnaires for HRQOL of life (EQ-VAS)
Time frame: At 2 weeks before surgery, and at 1 month, 6 months, and 12 months, as well as at years 2, 3, 4, and 5 after surgery.
Questionnaires for HRQOL of life (LCQ)
Time frame: at 1 month, 3 months, and 6 months after surgery.
Perioperative outcomes (Conversion rate)
Time frame: during hospitalization
Perioperative outcomes (number of lymph nodes harvested)
Time frame: during hospitalization
Perioperative outcomes (total operative time)
Time frame: during hospitalization
Perioperative outcomes (duration of chest tube drainage, postoperative hospital stays)
Time frame: during hospitalization
Perioperative outcomes (transfusion rate)
Time frame: within 30 days after surgery.
Perioperative outcomes (estimated blood loss )
Time frame: during surgery
5-year overall survival and disease-free survival
Time frame: 5 years
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 11 Jan 2024.
- Individual participant dataSharing planned: No
Related trials for Robotics
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Recruiting
MyHand-SCI: An Active Hand Orthosis for Spinal Cord Injury
Spinal Cord Injuries, Tetraplegia
Not yet recruiting
5G-Enabled Remote Robotic-Assisted Bronchoscopy-Guided Cryoablation for Pulmonary Malignancies
Lung Cancer
RecruitingPhase 2
A Single Arm Phase II Trial in p16-positive Oropharynx Cancer of Selective Dose De-escalation of nodAl VolumEs at Minimal Risk and Primary Site Disease (SAVED)
Head and Neck Cancer, Head and Neck Squamous Cell Cancer
Recruiting
Development of a Real-time Controller to Estimate Walking Performance Using a Bilateral Ankle Exoskeleton
Healthy Young Adults
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.
Questions about this trial
What is this clinical trial studying?
A study testing Single-port robotic-assisted thoracic surgery and Single-port video-assisted thoracoscopic surgery in people with Robotics and Lung Cancer, run by Korea University Guro Hospital.
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 6 inclusion and 10 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: opening soon, as of the sponsor's last update on 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 JunHee Lee (01072579550, lee2632@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative complications (time frame: Postoperative complications : within 30 days after surgery). The study lists 4 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 11 Jan 2024.