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Trial Title:
RATT Vs. VATT for Early-stage TETs
NCT ID:
NCT06654830
Condition:
Thymic Epithelial Tumor
Conditions: Official terms:
Neoplasms, Glandular and Epithelial
Thymus Neoplasms
Conditions: Keywords:
thymic epithelial tumor
robot-assisted
video-assisted
thoracoscopic thymectomy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Participant)
Intervention:
Intervention type:
Procedure
Intervention name:
RATT
Description:
Robotic-assisted thoracoscopic thymectomy (RATT) will be performed using Da Vinci Robotic
Surgical Systems.
Arm group label:
RATT
Intervention type:
Procedure
Intervention name:
VATT
Description:
Video-assisted thoracoscopic thymectomy (VATT) was performed using traditional
thoracoscopic systems.
Arm group label:
VATT
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. The trial was aimed to compare the perioperative outcomes between the two
approaches.
Criteria for 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 gradeļ¼1-2; 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
November 1, 2024
Completion date:
November 30, 2027
Lead sponsor:
Agency:
Shanghai Zhongshan Hospital
Agency class:
Other
Collaborator:
Agency:
Qilu Hospital of Shandong University
Agency class:
Other
Collaborator:
Agency:
The First Affiliated Hospital of Zhengzhou University
Agency class:
Other
Source:
Shanghai Zhongshan Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06654830
