ThymomaRATSNCT05262582
Comparison of Single Port and Two Ports Robotic Assisted Thoracic Surgery for Thymectomy
A study testing Sigle port RATS and Two ports RATS in people with Thymoma and Myasthenia Gravis Associated With Thymoma, run by Shanghai Pulmonary Hospital, Shanghai, China at 1 site in China.
Trial summary
Recently, robotic-assisted thoracic surgery (RATS) has become into as an alternative approach to either, open surgery or video-assisted thoracoscopic surgery. The superiorities of RATS have been reported in series studies, such as intuitive movements, tremor filtration, more degrees of manipulative freedom, motion… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Thymoma, Myasthenia Gravis Associated With Thymoma, Thymectomy
- What is being tested?
- Sigle port RATS and Two ports RATS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 10 May 2022to 1 Jan 2025
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Myasthenia Gravis and(or) thymoma need to perform thymectomy.
- Agree to accept Robotic Assisted Thoracic Surgery and have signed informed consent.
Who cannot join
- Cardiopulmonary function cannot tolerate thoracoscopic surgery or exist other contraindication.
- Thymic carcinoma.
- Thoracic deformity.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433
lei jiang, doctor, 13917912348, jiangleiem@aliyun.com
About this study
Official title: Randomized Open Label Two Arms Cohort Study to Evaluate Curative Effect and Quality of Life of Single Port and Two Ports Robotic Assisted Thoracic Surgery for Thymectomy
Recently, robotic-assisted thoracic surgery (RATS) has become into as an alternative approach to either, open surgery or video-assisted thoracoscopic surgery. The superiorities of RATS have been reported in series studies, such as intuitive movements, tremor filtration, more degrees of manipulative freedom, motion scaling, and high-definition stereoscopic vision.
However, the currently reported robotic thymectomy used 3 ports. Theoretically, less incisions may bring faster postoperative recovery, lighter postoperative pain and higher postoperative quality of life. The investigators have successfully performed robotic thymectomy through 2 ports and even 1 port. However, the potential benefit of less ports robotic thymectomy has not been verified through well-designed cohort study, so this clinical trial has been designed.
Read the detailed description
The gold standard technique for thymectomy used to be transsternal approach. Advancements in modern technology bring many evolutions in minimally invasive surgery such as Video-assisted thoracic surgery (VATS) thymectomy gained popularity after 2000s. Recently, robotic-assisted thoracic surgery (RATS) has become into as an alternative approach to either, open surgery or video-assisted thoracoscopic surgery. The superiorities of RATS have been reported in series studies, such as intuitive movements, tremor filtration, more degrees of manipulative freedom, motion scaling, and high-definition stereoscopic vision.
However, the currently reported robotic thymectomy used 3 ports. Theoretically, less incisions may bring faster postoperative recovery, lighter postoperative pain and higher postoperative quality of life. The investigators have successfully performed robotic thymectomy through 2 ports and even 1 port. However, the potential benefit of less ports robotic thymectomy has not been verified through well-designed cohort study, so this clinical trial has been designed.
- Being tested
- Sigle port RATS, Two ports RATS
- Keywords
- Thymoma, Myasthenia Gravis, Thymectomy, Robotic Assisted Thoracic Surgery
- Medical subject headings
- Thymoma, Myasthenia Gravis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sigle port RATSProcedure or surgery
The incision is performed in the 5-6th intercostal space under the breast folds without violating the mammalian tissue. This port is used for the camera and both arms simultaneously.
Two ports RATSProcedure or surgery
The incision is performed in the 4th intercostal space along anterior axillary fossa, for the camera and left arm. The other incision is subxiphoid longitudinal incision about 4cm for the right arm.
| Study group | Role | What they receive |
|---|---|---|
| Thymectomy performed with sigle port RATS | Experimental | The incision is performed in the 5-6th intercostal space under the breast folds without violating the mammalian tissue. This port is used for the camera and both arms simultaneously. Receives: Procedure: Sigle port RATS |
| Thymectomy performed with two ports RATS | Active comparator | The incision is performed in the 4th intercostal space along anterior axillary fossa, for the camera and left arm. The other incision is subxiphoid longitudinal incision about 4cm for the right arm. Receives: Procedure: Two ports RATS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operation pain
Measured with Visual Analogue Score (VAS-score)，the minimum value is 1, the maximum value is 10, higher scores mean a worse outcome.
Measured: 1 month after surgery
Secondary outcomes (4)
Surgical bleeding
Surgical bleeding measured with milliliter
Measured: During operation
Operation duration
Operation duration measured with minute
Measured: During operation
Quality of life after surgery
Measured with European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core30 (EORTC QLQ-C30 questionnaire), the higher scores mean a better outcome.
Measured: 6 months
Curative effect
Disease free survival 5 years after surgery
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 posted2 Mar 2022
- Study start10 May 2022
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ThymomaStudies of the same condition, open and under way.
- More trials run by Shanghai Pulmonary Hospital, Shanghai, ChinaThe 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lei Jiang, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05262582
- Sponsor's protocol ID
- jianglei4
- Acronym
- RATS
- Status last verified
- May 2022
- First submitted
- 16 Jan 2022
- Last updated
- 24 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Peng M, Wang X, Chen C, Tan S, Liu W, Yu F. Report on 153 sequential three-incision robotic-assisted pulmonary resections by a single surgeon: technical details and learning curve. J Thorac Dis. 2020 Mar;12(3):741-748. doi: 10.21037/jtd.2019.12.116.
PubMed 32274140Kaba E, Cosgun T, Ayalp K, Alomari MR, Toker A. Robotic thymectomy-a new approach for thymus. J Vis Surg. 2017 May 8;3:67. doi: 10.21037/jovs.2017.03.28. eCollection 2017.
PubMed 29078630Curcio C, Scaramuzzi R, Amore D. Robotic-assisted thoracoscopic surgery thymectomy. J Vis Surg. 2017 Nov 7;3:162. doi: 10.21037/jovs.2017.10.01. eCollection 2017.
PubMed 29302438Luzzi L, Corzani R, Ghisalberti M, Meniconi F, De Leonibus L, Molinaro F, Paladini P. Robotic surgery vs. open surgery for thymectomy, a retrospective case-match study. J Robot Surg. 2021 Jun;15(3):375-379. doi: 10.1007/s11701-020-01109-z. Epub 2020 Jul 6.
PubMed 32632562
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Open Label Two Arms Cohort Study to Evaluate Curative Effect and Quality of Life of Single Port and Two Ports Robotic Assisted Thoracic Surgery for Thymectomy
- ClinicalTrials.gov ID
- NCT05262582
- Acronym / sponsor ID
- RATS / jianglei4
- Keywords
- Thymoma, Myasthenia Gravis, Thymectomy, Robotic Assisted Thoracic Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, ChinaUniversity, hospital or other
- Study start
- 10 May 2022 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 2 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.
Recently, robotic-assisted thoracic surgery (RATS) has become into as an alternative approach to either, open surgery or video-assisted thoracoscopic surgery. The superiorities of RATS have been reported in series studies, such as intuitive movements, tremor filtration, more degrees of manipulative freedom, motion scaling, and high-definition stereoscopic vision.
However, the currently reported robotic thymectomy used 3 ports. Theoretically, less incisions may bring faster postoperative recovery, lighter postoperative pain and higher postoperative quality of life. The investigators have successfully performed robotic thymectomy through 2 ports and even 1 port. However, the potential benefit of less ports robotic thymectomy has not been verified through well-designed cohort study, so this clinical trial has been designed.
Detailed description
The gold standard technique for thymectomy used to be transsternal approach. Advancements in modern technology bring many evolutions in minimally invasive surgery such as Video-assisted thoracic surgery (VATS) thymectomy gained popularity after 2000s. Recently, robotic-assisted thoracic surgery (RATS) has become into as an alternative approach to either, open surgery or video-assisted thoracoscopic surgery. The superiorities of RATS have been reported in series studies, such as intuitive movements, tremor filtration, more degrees of manipulative freedom, motion scaling, and high-definition stereoscopic vision.
However, the currently reported robotic thymectomy used 3 ports. Theoretically, less incisions may bring faster postoperative recovery, lighter postoperative pain and higher postoperative quality of life. The investigators have successfully performed robotic thymectomy through 2 ports and even 1 port. However, the potential benefit of less ports robotic thymectomy has not been verified through well-designed cohort study, so this clinical trial has been designed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thymectomy performed with sigle port RATS | Experimental | Procedure: Sigle port RATSThe incision is performed in the 5-6th intercostal space under the breast folds without violating the mammalian tissue. This port is used for the camera and both arms simultaneously. |
| Thymectomy performed with two ports RATS | Active comparator | Procedure: Two ports RATSThe incision is performed in the 4th intercostal space along anterior axillary fossa, for the camera and left arm. The other incision is subxiphoid longitudinal incision about 4cm for the right arm. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with Myasthenia Gravis and(or) thymoma need to perform thymectomy.
- Agree to accept Robotic Assisted Thoracic Surgery and have signed informed consent.
Key exclusion criteria (3 listed)
- Cardiopulmonary function cannot tolerate thoracoscopic surgery or exist other contraindication.
- Thymic carcinoma.
- Thoracic deformity.
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 |
|---|---|---|
| Sigle port RATSThe incision is performed in the 5-6th intercostal space under the breast folds without violating the mammalian tissue. This port is used for the camera and both arms simultaneously. | Procedure or surgery | Thymectomy performed with sigle port RATS |
| Two ports RATSThe incision is performed in the 4th intercostal space along anterior axillary fossa, for the camera and left arm. The other incision is subxiphoid longitudinal incision about 4cm for the right arm. | Procedure or surgery | Thymectomy performed with two ports RATS |
Primary outcome
Post operation pain
Time frame: 1 month after surgery
Measured with Visual Analogue Score (VAS-score)，the minimum value is 1, the maximum value is 10, higher scores mean a worse outcome.
4 secondary outcomes
Surgical bleeding
Time frame: During operation
Operation duration
Time frame: During operation
Quality of life after surgery
Time frame: 6 months
Curative effect
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
- Background: PubMed 32274140Peng M, Wang X, Chen C, Tan S, Liu W, Yu F. Report on 153 sequential three-incision robotic-assisted pulmonary resections by a single surgeon: technical details and learning curve. J Thorac Dis. 2020 Mar;12(3):741-748. doi: 10.21037/jtd.2019.12.116.
- Background: PubMed 29078630Kaba E, Cosgun T, Ayalp K, Alomari MR, Toker A. Robotic thymectomy-a new approach for thymus. J Vis Surg. 2017 May 8;3:67. doi: 10.21037/jovs.2017.03.28. eCollection 2017.
- Background: PubMed 29302438Curcio C, Scaramuzzi R, Amore D. Robotic-assisted thoracoscopic surgery thymectomy. J Vis Surg. 2017 Nov 7;3:162. doi: 10.21037/jovs.2017.10.01. eCollection 2017.
- Background: PubMed 32632562Luzzi L, Corzani R, Ghisalberti M, Meniconi F, De Leonibus L, Molinaro F, Paladini P. Robotic surgery vs. open surgery for thymectomy, a retrospective case-match study. J Robot Surg. 2021 Jun;15(3):375-379. doi: 10.1007/s11701-020-01109-z. Epub 2020 Jul 6.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sigle port RATS and Two ports RATS in people with Thymoma and Myasthenia Gravis Associated With Thymoma, run by Shanghai Pulmonary Hospital, Shanghai, China 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 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 24 May 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact lei jiang, doctor (+8613917912348, jiangleiem@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post operation pain (time frame: 1 month after surgery). 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 NCT05262582, which also lists 4 linked publications.
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 24 May 2022.