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NCT Number: NCT06654830

RATT Vs. VATT for Early-stage TETs

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

RATT

Procedure

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

VATT

Procedure

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

Primary outcomes

  1. Postoperative draingage volume

    Time frame: Up to 7 days.

    Postoperative draingage volume is the total draingage volume after surgery.

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.

  5. duration of drainage

    Time frame: from the day of the surgery to the day of removal of drainage tubes. Up to 7 days.

  6. postoperative hospital stays

    Time frame: from the day of the surgery to the day of discharge. Up to 30 days

  7. re-operation rate

    Time frame: from the day of the surgery to the day of discharge. Up to 7 days

  8. 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

  9. 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

  10. 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

  11. 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

  12. serum procalcitonin level at postoperaive day 1

    Time frame: from the day of the surgery to the day of discharge. Up to 7 days

  13. serum procalcitonin level at postoperaive day 2

    Time frame: from the day of the surgery to the day of discharge. Up to 7 days

  14. 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

  15. 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

  16. complication rate

    Time frame: from the day of the surgery to the day of discharge. Up to 30 days

  17. 3-year disease-free survival

    Time frame: from the day of the surgery to the postoperative 3 years. Up to 3 years

  18. 3-year overall survival

    Time frame: from the day of the surgery to the postoperative 3 years. Up to 3 years

Study contacts

Contact information is provided by the study sponsor or research team.

Jianyong Ding, Ph.D.

CONTACT

[email protected]

086+64041990

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Collaborators

  • Qilu Hospital of Shandong University
  • The First Affiliated Hospital of Zhengzhou University

Registry information

Official study title

Robotic-assisted Versus Video-assisted Thoracoscopic Thymectomy for Thymic Epithelial Tumor in Stage I-II: a Prospective, Multi-center, Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Oct 23, 2024
Registry last updated
Oct 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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