ThymomaNCT06029621
Robot-assisted vs VATS for Thymoma
A study testing RATS for Thymectomy and VATS for Thymectomy in people with Thymoma, run by Shanghai Pulmonary Hospital, Shanghai, China at 2 sites in China.
Trial summary
The aim of this study is to explore the advantages of robot-assisted thymectomy in long-term survival benefits and short-term clinical efficacy compared with video-assisted thoracoscopic thymectomy based on a multi-center, prospective, randomized controlled clinical trial. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Thymoma
- What is being tested?
- RATS for Thymectomy and VATS for Thymectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 304 participants
- Where
- 2 sitesChina
- Study dates
- 20 Nov 2023to 19 Sep 2030
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ) The age of the subjects on the day of signing the informed consent was ≥ 18 years old and < 75 years old, regardless of gender ;
- ) Chest thin-layer CT and MR showed anterior mediastinal space-occupying lesions, combined with relevant hematological indicators, the patient was clinically diagnosed as a thymic epithelial tumor with or without myasthenia gravis ( MG ) symptoms.
- ) need to accept thymectomy surgery ;
- ) Clinical stage I to IIIA ( AJCC-UICC TNM staging system ) ;
- ) The maximum diameter of the lesion < 5cm ;
- ) physical condition score 0 or 1 ( Eastern Cooperative Oncology Group ECOG scoring system ) ;
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- ) Have not received any anti-thymoma therapy before, including but not limited to systemic chemotherapy, radiotherapy, etc. ;
- ) Preoperative major organ function meets the following criteria : Bone marrow function: hemoglobin ≥ 10.0 g / dL ( no blood transfusion within 28 days before hemoglobin examination ), absolute neutrophil count ≥ 1.5 × 109 / L, platelet count ≥ 100 × 109 / L ( no transfusion of apheresis platelets or IL-11 treatment within 14 days before platelet count examination ) ; coagulation function : INR and PT < 1.5 × ULN, APTT ≤ 1.5 × ULN ; liver function: transaminase ( ALT and AST ) ≤ 2.5 × ULN; total bilirubin ≤ 1.5 × ULN ( Gilbert's syndrome or liver metastasis subjects total bilirubin ≤ 2.5 × ULN ) ; renal function: serum creatinine clearance rate ≥ 60 mL/min ( calculated according to the Cockcroft-Gault formula ) ;
- ) voluntarily participated in and were able to undergo robot-assisted or thoracoscopic thymectomy, and complied with the study follow-up plan.
Who cannot join
- ) Patients with myasthenia gravis crisis ;
- ) had undergone mediastinal surgery or cardiac surgery ;
- ) body mass index ( BMI ) ≥ 30 ;
- ) Patients with severe liver and kidney dysfunction ( ALT and/or AST more than three times the upper limit of normal, Cr more than the upper limit of normal ) ;
- ) combined with severe chronic lung diseases such as COPD, asthma, or interstitial lung disease ;
- ) suffering from uncontrolled heart, kidney, gastrointestinal, and infectious diseases and other complications ;
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- ) patients with other malignant tumors or hematological diseases ;
- ) combined with chronic pain or preoperative use of opioid analgesics ;
- ) patients with thoracic deformity or combined with pectus carinatum and pectus excavatum ;
- ) have mental disorders, such as anxiety disorders ;
- ) pregnant and/or lactating women ;
- ) is currently participating in other interventional clinical studies.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality
Deping Zhao, zdp1992@163.com
- Not yet recruiting
The Second Affiliated Hospital Zhejiang University School of Medicine
Zhejiang
Junqiang Fan
About this study
Official title: Comparison of Short-term and Longterm Outcomes Between Robot-assisted Thoracoscopy and Television-assisted Thoracoscopy Surgery Forthymoma : a Multicenter, Prospective, Randomized Controlled Study
The aim of this study is to explore the advantages of robot-assisted thymectomy in long-term survival benefits and short-term clinical efficacy compared with video-assisted thoracoscopic thymectomy based on a multi-center, prospective, randomized controlled clinical trial.
Read the detailed description
Video-assisted thoracoscopic surgery ( VATS ) is widely used in thoracic surgery and has gradually replaced traditional thoracotomy in thymoma. As a new type of VATS, the long-term oncological results of robot-assisted thoracoscopic surgery in thymoma have not been verified. Therefore, we designed a multicenter, prospective, randomized controlled clinical trial to determine whether RATS thymectomy is as effective as VATS thymectomy in terms of short-term and long-term outcomes.
- Conditions
- Thymoma
- Being tested
- RATS for Thymectomy, VATS for Thymectomy
- Medical subject headings
- Thymoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RATS for ThymectomyProcedure or surgery
a minimally invasive surgical type for Thymoma: RATS
VATS for ThymectomyProcedure or surgery
a minimally invasive surgical type for Thymoma: VATS
| Study group | Role | What they receive |
|---|---|---|
| RATS for Thymectomy | Experimental | The operator of the surgical incision and the route of entry were determined, and the endoscope and surgical instruments were inserted through the operating hole. The phrenic nerve and diaphragm began to gradually separate upward while avoiding nerve damage. Subsequently, the innominate vein was dissected to observe the branches of the thymus vessels and clamped with a 5 mm Hem-o-Lok clamp. Continue to dissect the left side of the thymus until near the phrenic nerve. After the thymus was removed entirely, it was placed in a bag and removed through an incision. After the operation, a 28 Fr chest tube was placed through the incision to the chest top. An 18 G central venous catheter was placed at the level of the posterior axillary line to the posterior costophrenic angle, and about 10 cm was inserted. Receives: Procedure: RATS for Thymectomy |
| VATS for Thymectomy | Active comparator | The main operation principles and procedures of the operation are basically similar to those of the RATS and are completed under video-assisted thoracoscopic surgery. Receives: Procedure: VATS for Thymectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
5-year overall survival (OS)
OS at 5 year after surgery
Measured: 5 year after surgery
Secondary outcomes (15)
Pain score
Pain was assessed using a pain scale on the first day, 1 month, 6 months and 1 year after surgery. Pain was evaluated using the visual analogue scale (VAS) and the numerical rating scale (NRS), with higher scores indicating greater pain
Measured: at 1 year after surgery
quality of life (QOL) at 1 year by EORTC QLQ-C30
Quality of life was assessed at 1 month, 6 months and 1 year after surgery. QQL was evaluated using the European Organization for the Treatment and Research of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) version 3.0
Measured: at 1 year after surgery
quality of life (QOL) at 1 year by EQ-5D
Quality of life was assessed at 1 month, 6 months and 1 year after surgery. QQL was evaluated using the European Five Dimensional Health Scale (EQ-5D).
Measured: at 1 year after surgery
R0 rate
R0 radical rate
Measured: postoperative in-hospital stay up to 30 days
operative time
the time of operation
Measured: Intraoperative
blood loss
blood loss in the operation
Measured: Intraoperative
conversion rate
the rate of conversion to open surgery in the operation
Measured: Intraoperative
length of hospital stay (LOS)
length of stay in hospitalization
Measured: postoperative in-hospital stay up to 30 days
Catheterization days
The interval days from the completion of catheter insertion to the removal of the thoracic tube
Measured: postoperative in-hospital stay up to 30 days
Volume of drainage
Volume of drainage from the completion of catheter insertion to the removal of the thoracic tube
Measured: postoperative in-hospital stay up to 30 days
postoperative complications
mainly include: pneumonia, arrhythmia, incision infection, vocal cord paralysis, trachea cannula
Measured: postoperative in-hospital stay up to 30 days
30-day mortality
30-day mortality after surgery
Measured: postoperative in-hospital stay up to 30 days
30-day readmission rate after surgery
Rate of readmission due to postoperative complications
Measured: postoperative in-hospital stay up to 30 days
5-year disease-free survival (DFS)
DFS at 5 year after surgery
Measured: 5 year after surgery
Tumor recurrence rate
The rate of recurrence of thymoma in patients after surgery
Measured: 5 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start20 Nov 2023
- Primary completion19 Sep 2030 (estimated)
- Study completion19 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThymomaStudies 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
- RATS versus VATS
- Masking
- None (open label)
- Enrolment
- 304 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deping Zhao, Shanghai Pulmonary Hospital, Shanghai, China
- Investigators
- Deping Zhao, MD,PhD, Principal investigator, Shanghai Pulmonary Hospital, School of Medicine, Tongji University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06029621
- Sponsor's protocol ID
- STAR006
- Status last verified
- Feb 2024
- First submitted
- 28 Aug 2023
- Last updated
- 29 Feb 2024
- Results posted
- 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 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Short-term and Longterm Outcomes Between Robot-assisted Thoracoscopy and Television-assisted Thoracoscopy Surgery Forthymoma : a Multicenter, Prospective, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06029621
- Acronym / sponsor ID
- STAR006
- Conditions
- Thymoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 304 participants (estimated)
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, ChinaUniversity, hospital or other
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- 19 Sep 2030 (estimated)
- Study completion
- 19 Sep 2030 (estimated)
- First posted
- 8 Sep 2023 (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.
The aim of this study is to explore the advantages of robot-assisted thymectomy in long-term survival benefits and short-term clinical efficacy compared with video-assisted thoracoscopic thymectomy based on a multi-center, prospective, randomized controlled clinical trial.
Detailed description
Video-assisted thoracoscopic surgery ( VATS ) is widely used in thoracic surgery and has gradually replaced traditional thoracotomy in thymoma. As a new type of VATS, the long-term oncological results of robot-assisted thoracoscopic surgery in thymoma have not been verified. Therefore, we designed a multicenter, prospective, randomized controlled clinical trial to determine whether RATS thymectomy is as effective as VATS thymectomy in terms of short-term and long-term outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- RATS versus VATS
| Arm | Type | Receives |
|---|---|---|
| RATS for Thymectomy | Experimental | Procedure: RATS for ThymectomyThe operator of the surgical incision and the route of entry were determined, and the endoscope and surgical instruments were inserted through the operating hole. The phrenic nerve and diaphragm began to gradually separate upward while avoiding nerve damage. Subsequently, the innominate vein was dissected to observe the branches of the thymus vessels and clamped with a 5 mm Hem-o-Lok clamp. Continue to dissect the left side of the thymus until near the phrenic nerve. After the thymus was removed entirely, it was placed in a bag and removed through an incision. After the operation, a 28 Fr chest tube was placed through the incision to the chest top. An 18 G central venous catheter was placed at the level of the posterior axillary line to the posterior costophrenic angle, and about 10 cm was inserted. |
| VATS for Thymectomy | Active comparator | Procedure: VATS for ThymectomyThe main operation principles and procedures of the operation are basically similar to those of the RATS and are completed under video-assisted thoracoscopic surgery. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- ) The age of the subjects on the day of signing the informed consent was ≥ 18 years old and < 75 years old, regardless of gender ;
- ) Chest thin-layer CT and MR showed anterior mediastinal space-occupying lesions, combined with relevant hematological indicators, the patient was clinically diagnosed as a thymic epithelial tumor with or without myasthenia gravis ( MG ) symptoms.
- ) need to accept thymectomy surgery ;
- ) Clinical stage I to IIIA ( AJCC-UICC TNM staging system ) ;
- ) The maximum diameter of the lesion < 5cm ;
Key exclusion criteria (12 listed)
- ) Patients with myasthenia gravis crisis ;
- ) had undergone mediastinal surgery or cardiac surgery ;
- ) body mass index ( BMI ) ≥ 30 ;
- ) Patients with severe liver and kidney dysfunction ( ALT and/or AST more than three times the upper limit of normal, Cr more than the upper limit of normal ) ;
- ) combined with severe chronic lung diseases such as COPD, asthma, or interstitial lung disease ;
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 |
|---|---|---|
| RATS for Thymectomya minimally invasive surgical type for Thymoma: RATS | Procedure or surgery | RATS for Thymectomy |
| VATS for Thymectomya minimally invasive surgical type for Thymoma: VATS | Procedure or surgery | VATS for Thymectomy |
Primary outcome
5-year overall survival (OS)
Time frame: 5 year after surgery
OS at 5 year after surgery
15 secondary outcomes
Pain score
Time frame: at 1 year after surgery
quality of life (QOL) at 1 year by EORTC QLQ-C30
Time frame: at 1 year after surgery
quality of life (QOL) at 1 year by EQ-5D
Time frame: at 1 year after surgery
R0 rate
Time frame: postoperative in-hospital stay up to 30 days
operative time
Time frame: Intraoperative
blood loss
Time frame: Intraoperative
conversion rate
Time frame: Intraoperative
length of hospital stay (LOS)
Time frame: postoperative in-hospital stay up to 30 days
Catheterization days
Time frame: postoperative in-hospital stay up to 30 days
Volume of drainage
Time frame: postoperative in-hospital stay up to 30 days
postoperative complications
Time frame: postoperative in-hospital stay up to 30 days
30-day mortality
Time frame: postoperative in-hospital stay up to 30 days
30-day readmission rate after surgery
Time frame: postoperative in-hospital stay up to 30 days
5-year disease-free survival (DFS)
Time frame: 5 year after surgery
Tumor recurrence rate
Time frame: 5 year after surgery
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 29 Feb 2024.
- 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.
Deping Zhao, MD,PhD principal investigator
Shanghai Pulmonary Hospital, School of Medicine, Tongji University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RATS for Thymectomy and VATS for Thymectomy in people with Thymoma, run by Shanghai Pulmonary Hospital, Shanghai, China at 2 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 9 inclusion and 12 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 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
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 Juemin Yu (+8615927548511, yujm96@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5-year overall survival (OS) (time frame: 5 year 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 29 Feb 2024; AzTrials last refreshed its copy on 26 Oct 2026.