Thymic Epithelial TumorPhase 2NCT06654830
RATT Vs. VATT for Early-stage TETs
A Phase 2 study testing RATT and VATT in people with Thymic Epithelial Tumor, run by Shanghai Zhongshan Hospital.
Trial summary
This study is a prospective, multicenter, phase II randomized controlled trial. We plan to screen 100 eligible thymoma patients for robotic-assisted thoracoscopic thymectomy (RATT) or video-assisted thoracoscopic thymectomy (VATT) at three medical centers in China. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Thymic Epithelial Tumor
- What is being tested?
- RATT and VATT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2024to 30 Nov 2027
- Phase
- Phase 2
- 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
- Thymoma was diagnosed by chest enhanced CT or MRI (clinical stage: Masaoka Koga I-II) with AJCC/UICC TNM grade system (9th edition).
- The patients whose tumor diameter was not larger than 8 cm; The patients with the estimated survival time should be over 12 months; ASA grade：1-2; The patients should have no functional disorders in main organs; The patients should be able to understand our research and sign the informed consent.
Who cannot join
- Imaging examination showed that the tumor had invasion of surrounding organs, pleural or pericardial dissemination, lymphatic or hematogenous metastasis; Patients with myasthenia gravis; Patients had undergone a sternotomy; The patients have proved history of congestive heart failure, angina without good control with medicine; ECG-proved penetrating myocardial infarction; hypertension with bad control; valvulopathy with clinical significance; arrhythmia with high risk and out of control; The patients have severe systematic intercurrent disease, such as active infection or poorly controlled diabetes; coagulation disorders; hemorrhagic tendency or under treatment of thrombolysis or anticoagulant therapy; Female who is positive for serum pregnancy test or during lactation period; The patients have history of organ transplantation (including autologous bone marrow transplantation and peripheral stem cell transplantation; The patients have history of peripheral nerve system disorders, obvious mental disorders or central nerve system disorders; The patients attend other clinical trials.
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: Robotic-assisted Versus Video-assisted Thoracoscopic Thymectomy for Thymic Epithelial Tumor in Stage I-II: a Prospective, Multi-center, Randomized Controlled Trial
This study is a prospective, multicenter, phase II randomized controlled trial. We plan to screen 100 eligible thymoma patients for robotic-assisted thoracoscopic thymectomy (RATT) or video-assisted thoracoscopic thymectomy (VATT) at three medical centers in China. The trial was aimed to compare the perioperative outcomes between the two approaches.
- Conditions
- Thymic Epithelial Tumor
- Being tested
- RATT, VATT
- Keywords
- thymic epithelial tumor, robot-assisted, video-assisted, thoracoscopic thymectomy
- Medical subject headings
- Thymic epithelial tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RATTProcedure or surgery
Robotic-assisted thoracoscopic thymectomy (RATT) will be performed using Da Vinci Robotic Surgical Systems.
VATTProcedure or surgery
Video-assisted thoracoscopic thymectomy (VATT) was performed using traditional thoracoscopic systems.
| Study group | Role | What they receive |
|---|---|---|
| RATT | Experimental | robotic-assisted thoracoscopic thymectomy Receives: Procedure: RATT |
| VATT | Active comparator | video-assisted thoracoscopic thymectomy Receives: Procedure: VATT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative draingage volume
Postoperative draingage volume is the total draingage volume after surgery.
Measured: Up to 7 days.
Secondary outcomes (18)
complete recestion rate
Measured: Up to 7 days.
the counts of lymph node sampling
Measured: From the time at start of the surgery to the time at end of the surgery. Up to 7 days.
operative time
Measured: From the time at start of the surgery to the time at end of the surgery. Up to 7 days.
bleeding volume
Measured: From the time at start of the surgery to the time at end of the surgery. Up to 7 days.
duration of drainage
Measured: from the day of the surgery to the day of removal of drainage tubes. Up to 7 days.
postoperative hospital stays
Measured: from the day of the surgery to the day of discharge. Up to 30 days
re-operation rate
Measured: from the day of the surgery to the day of discharge. Up to 7 days
C-reactive protein level at postoperaive day 1
Measured: from the day of the surgery to the day of discharge. Up to 7 days
C-reactive protein level at postoperaive day 2
Measured: from the day of the surgery to the day of discharge. Up to 7 days
serum interleukin-6 level at postoperaive day 1
Measured: from the day of the surgery to the day of discharge. Up to 7 days
serum interleukin-6 level at postoperaive day 2
Measured: from the day of the surgery to the day of discharge. Up to 7 days
serum procalcitonin level at postoperaive day 1
Measured: from the day of the surgery to the day of discharge. Up to 7 days
serum procalcitonin level at postoperaive day 2
Measured: from the day of the surgery to the day of discharge. Up to 7 days
pain visual analogue scale score at postoperative day 1, 2, 3 and 7
Measured: from the day of the surgery to the postoperative day 7. Up to 7 days
quality of life score at postoperative day 30, 60 and 180
Measured: from the day of the surgery to the postoperative day 180. Up to 180 days
complication rate
Measured: from the day of the surgery to the day of discharge. Up to 30 days
3-year disease-free survival
Measured: from the day of the surgery to the postoperative 3 years. Up to 3 years
3-year overall survival
Measured: from the day of the surgery to the postoperative 3 years. Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start1 Nov 2024 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thymic Epithelial TumorStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Qilu Hospital of Shandong University, The First Affiliated Hospital of Zhengzhou University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06654830
- Sponsor's protocol ID
- KY2024455
- Status last verified
- Oct 2024
- First submitted
- 28 Sep 2024
- Last updated
- 30 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: National policy.
Publications
Wang S, Zhu J, Sun Z, Jiang J, Wu B, Liang F, Zheng Y, Yang X, Jiang X, Ao YQ, Gao J, Tan L, Qi Y, Yue W, Ding J. Robot-assisted versus video-assisted thoracoscopic thymectomy for stage I-II thymic epithelial tumour: a protocol for the first multicentre, randomised controlled clinical trial. BMJ Open. 2025 May 28;15(5):e095802. doi: 10.1136/bmjopen-2024-095802.
PubMed 40441770
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic-assisted Versus Video-assisted Thoracoscopic Thymectomy for Thymic Epithelial Tumor in Stage I-II: a Prospective, Multi-center, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06654830
- Acronym / sponsor ID
- KY2024455
- Conditions
- Thymic Epithelial Tumor
- Keywords
- thymic epithelial tumor, robot-assisted, video-assisted, thoracoscopic thymectomy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Collaborators
- Qilu Hospital of Shandong University, The First Affiliated Hospital of Zhengzhou University
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 23 Oct 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.
This study is a prospective, multicenter, phase II randomized controlled trial. We plan to screen 100 eligible thymoma patients for robotic-assisted thoracoscopic thymectomy (RATT) or video-assisted thoracoscopic thymectomy (VATT) at three medical centers in China. The trial was aimed to compare the perioperative outcomes between the two approaches.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RATT | Experimental | Procedure: RATTrobotic-assisted thoracoscopic thymectomy |
| VATT | Active comparator | Procedure: VATTvideo-assisted thoracoscopic thymectomy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Thymoma was diagnosed by chest enhanced CT or MRI (clinical stage: Masaoka Koga I-II) with AJCC/UICC TNM grade system (9th edition).
- The patients whose tumor diameter was not larger than 8 cm; The patients with the estimated survival time should be over 12 months; ASA grade：1-2; The patients should have no functional disorders in main organs; The patients should be able to understand our research and sign the informed consent.
Key exclusion criteria (1 listed)
- Imaging examination showed that the tumor had invasion of surrounding organs, pleural or pericardial dissemination, lymphatic or hematogenous metastasis; Patients with myasthenia gravis; Patients had undergone a sternotomy; The patients have proved history of congestive heart failure, angina without good control with medicine; ECG-proved penetrating myocardial infarction; hypertension with bad control; valvulopathy with clinical significance; arrhythmia with high risk and out of control; The patients have severe systematic intercurrent disease, such as active infection or poorly controlled diabetes; coagulation disorders; hemorrhagic tendency or under treatment of thrombolysis or anticoagulant therapy; Female who is positive for serum pregnancy test or during lactation period; The patients have history of organ transplantation (including autologous bone marrow transplantation and peripheral stem cell transplantation; The patients have history of peripheral nerve system disorders, obvious mental disorders or central nerve system disorders; The patients attend other clinical trials.
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 |
|---|---|---|
| RATTRobotic-assisted thoracoscopic thymectomy (RATT) will be performed using Da Vinci Robotic Surgical Systems. | Procedure or surgery | RATT |
| VATTVideo-assisted thoracoscopic thymectomy (VATT) was performed using traditional thoracoscopic systems. | Procedure or surgery | VATT |
Primary outcome
Postoperative draingage volume
Time frame: Up to 7 days.
Postoperative draingage volume is the total draingage volume after surgery.
18 secondary outcomes
complete recestion rate
Time frame: Up to 7 days.
the counts of lymph node sampling
Time frame: From the time at start of the surgery to the time at end of the surgery. Up to 7 days.
operative time
Time frame: From the time at start of the surgery to the time at end of the surgery. Up to 7 days.
bleeding volume
Time frame: From the time at start of the surgery to the time at end of the surgery. Up to 7 days.
duration of drainage
Time frame: from the day of the surgery to the day of removal of drainage tubes. Up to 7 days.
postoperative hospital stays
Time frame: from the day of the surgery to the day of discharge. Up to 30 days
re-operation rate
Time frame: from the day of the surgery to the day of discharge. Up to 7 days
C-reactive protein level at postoperaive day 1
Time frame: from the day of the surgery to the day of discharge. Up to 7 days
C-reactive protein level at postoperaive day 2
Time frame: from the day of the surgery to the day of discharge. Up to 7 days
serum interleukin-6 level at postoperaive day 1
Time frame: from the day of the surgery to the day of discharge. Up to 7 days
serum interleukin-6 level at postoperaive day 2
Time frame: from the day of the surgery to the day of discharge. Up to 7 days
serum procalcitonin level at postoperaive day 1
Time frame: from the day of the surgery to the day of discharge. Up to 7 days
serum procalcitonin level at postoperaive day 2
Time frame: from the day of the surgery to the day of discharge. Up to 7 days
pain visual analogue scale score at postoperative day 1, 2, 3 and 7
Time frame: from the day of the surgery to the postoperative day 7. Up to 7 days
quality of life score at postoperative day 30, 60 and 180
Time frame: from the day of the surgery to the postoperative day 180. Up to 180 days
complication rate
Time frame: from the day of the surgery to the day of discharge. Up to 30 days
3-year disease-free survival
Time frame: from the day of the surgery to the postoperative 3 years. Up to 3 years
3-year overall survival
Time frame: from the day of the surgery to the postoperative 3 years. Up to 3 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 30 Oct 2024.
- Derived from this study: PubMed 40441770Wang S, Zhu J, Sun Z, Jiang J, Wu B, Liang F, Zheng Y, Yang X, Jiang X, Ao YQ, Gao J, Tan L, Qi Y, Yue W, Ding J. Robot-assisted versus video-assisted thoracoscopic thymectomy for stage I-II thymic epithelial tumour: a protocol for the first multicentre, randomised controlled clinical trial. BMJ Open. 2025 May 28;15(5):e095802. doi: 10.1136/bmjopen-2024-095802.
- Individual participant dataSharing planned: No. National policy.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RATT and VATT in people with Thymic Epithelial Tumor, run by Shanghai Zhongshan 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 2 inclusion and 1 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 30 Oct 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Jianyong Ding, Ph.D. (086+64041990, ding.jianyong@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative draingage volume (time frame: Up to 7 days.). 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 NCT06654830, which also lists 1 linked publication.
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 30 Oct 2024.