Clinical trial NCT06654830: RATT Vs. VATT for Early-stage TETs
Official title: Robotic-assisted Versus Video-assisted Thoracoscopic Thymectomy for Thymic Epithelial Tumor in Stage I-II: a Prospective, Multi-center, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Thymic Epithelial Tumor
Keywords: thymic epithelial tumor
robot-assisted
video-assisted
thoracoscopic thymectomy
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
Collaborators: name: Qilu Hospital of Shandong University
name: The First Affiliated Hospital of Zhengzhou University
First posted: 2024-10-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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.

Primary outcomes:
measure: Postoperative draingage volume
timeFrame: Up to 7 days.
Secondary outcomes:
measure: complete recestion rate
timeFrame: Up to 7 days.
measure: the counts of lymph node sampling
timeFrame: From the time at start of the surgery to the time at end of the surgery. Up to 7 days.
measure: operative time
timeFrame: From the time at start of the surgery to the time at end of the surgery. Up to 7 days.
measure: bleeding volume
timeFrame: From the time at start of the surgery to the time at end of the surgery. Up to 7 days.
measure: duration of drainage
timeFrame: from the day of the surgery to the day of removal of drainage tubes. Up to 7 days.
measure: postoperative hospital stays
timeFrame: from the day of the surgery to the day of discharge. Up to 30 days
measure: re-operation rate
timeFrame: from the day of the surgery to the day of discharge. Up to 7 days
measure: C-reactive protein level at postoperaive day 1
timeFrame: from the day of the surgery to the day of discharge. Up to 7 days
measure: C-reactive protein level at postoperaive day 2
timeFrame: from the day of the surgery to the day of discharge. Up to 7 days
measure: serum interleukin-6 level at postoperaive day 1
timeFrame: from the day of the surgery to the day of discharge. Up to 7 days
measure: serum interleukin-6 level at postoperaive day 2
timeFrame: from the day of the surgery to the day of discharge. Up to 7 days
measure: serum procalcitonin level at postoperaive day 1
timeFrame: from the day of the surgery to the day of discharge. Up to 7 days
measure: serum procalcitonin level at postoperaive day 2
timeFrame: from the day of the surgery to the day of discharge. Up to 7 days
measure: pain visual analogue scale score at postoperative day 1, 2, 3 and 7
timeFrame: from the day of the surgery to the postoperative day 7. Up to 7 days
measure: quality of life score at postoperative day 30, 60 and 180
timeFrame: from the day of the surgery to the postoperative day 180. Up to 180 days
measure: complication rate
timeFrame: from the day of the surgery to the day of discharge. Up to 30 days
measure: 3-year disease-free survival
timeFrame: from the day of the surgery to the postoperative 3 years. Up to 3 years
measure: 3-year overall survival
timeFrame: from the day of the surgery to the postoperative 3 years. Up to 3 years
Other outcomes:
Locations:
Study officials:
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