RATT Vs. VATT for Early-stage TETs
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: RATT, VATT.
- Who it may be relevant to
- Registry conditions: Thymic Epithelial Tumor. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Robotic-assisted Versus Video-assisted Thoracoscopic Thymectomy for Thymic Epithelial Tumor in Stage I-II: a Prospective, Multi-center, Randomized Controlled Trial
Overview
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.
Interventions
- Procedure RATT
Robotic-assisted thoracoscopic thymectomy (RATT) will be performed using Da Vinci Robotic Surgical Systems. - Procedure VATT
Video-assisted thoracoscopic thymectomy (VATT) was performed using traditional thoracoscopic systems.
Primary outcome measures
- Postoperative draingage volume [Time frame: Up to 7 days.]
Secondary outcome measures (12)
- 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]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
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. PMID 40441770
Identifiers
NCT: NCT06654830 · KY2024455