RATT Vs. VATT for Early-stage TETs

NCT06654830 | Not Yet Recruiting Phase 2

• 1 other identifier: KY2024455
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Thymic Epithelial Tumor

Keywords

thymic epithelial tumor; robot-assisted; video-assisted; thoracoscopic thymectomy

Outcome Measures

Primary Outcomes (1)

• Postoperative draingage volume

  Postoperative draingage volume is the total draingage volume after surgery.

  Up to 7 days.

Secondary Outcomes (18)

• complete recestion rate

  Up to 7 days.

• the counts of lymph node sampling

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

• operative time

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

• bleeding volume

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

• duration of drainage

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

Study Arms (2)

RATT

EXPERIMENTAL

robotic-assisted thoracoscopic thymectomy

Procedure: RATT

VATT

ACTIVE COMPARATOR

video-assisted thoracoscopic thymectomy

Procedure: VATT

Interventions

RATT PROCEDURE

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

RATT

VATT PROCEDURE

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

VATT

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead
• Qilu Hospital of Shandong University: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Thymic epithelial tumor

Central Study Contacts

Jianyong Ding, Ph.D.

CONTACT

086+64041990; ding.jianyong@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2024
• First Posted: October 23, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): November 30, 2027
• Last Updated: October 30, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share