RATT Vs. VATT for Early-stage TETs

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Zhongshan Hospital

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Thymoma was diagnosed by chest enhanced CT or MRI (clinical stage: Masaoka Koga I-II) with AJCC/UICC TNM grade system (9th edition).

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • RATT

    Procedure/Surgery

    Robotic-assisted thoracoscopic thymectomy (RATT) will be performed using Da Vinci Robotic Surgical Systems.

  • VATT

    Procedure/Surgery

    Video-assisted thoracoscopic thymectomy (VATT) was performed using traditional thoracoscopic systems.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: RATTExperimental treatment 1 intervention
Group B: VATTActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Postoperative draingage volume

Postoperative draingage volume is the total draingage volume after surgery.

Time frame
Up to 7 days.

Secondary outcomes

1

complete recestion rate

Time frame
Up to 7 days.
2

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.
3

operative time

Time frame
From the time at start of the surgery to the time at end of the surgery. Up to 7 days.
4

bleeding volume

Time frame
From the time at start of the surgery to the time at end of the surgery. Up to 7 days.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Zhongshan Hospital

Lead sponsor

Qilu Hospital of Shandong University

Collaborator

The First Affiliated Hospital of Zhengzhou University

Collaborator

This trial is not recruiting at the moment. You can still explore other options: