RATT Vs. VATT for Early-stage TETs

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

Study Overview

• Status: Not yet recruiting
• Conditions: Thymic Epithelial Tumor
• Intervention / Treatment: Procedure: RATT; Procedure: VATT

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jianyong Ding, Ph.D.; Phone Number: 086+64041990; Email: ding.jianyong@zs-hospital.sh.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RATT; robotic-assisted thoracoscopic thymectomy	Procedure: RATT; Robotic-assisted thoracoscopic thymectomy (RATT) will be performed using Da Vinci Robotic Surgical Systems.
Active Comparator: VATT; video-assisted thoracoscopic thymectomy	Procedure: VATT; Video-assisted thoracoscopic thymectomy (VATT) was performed using traditional thoracoscopic systems.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative draingage volume	Postoperative draingage volume is the total draingage volume after surgery.	Up to 7 days.

Secondary Outcome Measures

Outcome Measure	Time Frame
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.
postoperative hospital stays	from the day of the surgery to the day of discharge. Up to 30 days
re-operation rate	from the day of the surgery to the day of discharge. Up to 7 days
C-reactive protein level at postoperaive day 1	from the day of the surgery to the day of discharge. Up to 7 days
C-reactive protein level at postoperaive day 2	from the day of the surgery to the day of discharge. Up to 7 days
serum interleukin-6 level at postoperaive day 1	from the day of the surgery to the day of discharge. Up to 7 days
serum interleukin-6 level at postoperaive day 2	from the day of the surgery to the day of discharge. Up to 7 days
serum procalcitonin level at postoperaive day 1	from the day of the surgery to the day of discharge. Up to 7 days
serum procalcitonin level at postoperaive day 2	from the day of the surgery to the day of discharge. Up to 7 days
pain visual analogue scale score at postoperative day 1, 2, 3 and 7	from the day of the surgery to the postoperative day 7. Up to 7 days
quality of life score at postoperative day 30, 60 and 180	from the day of the surgery to the postoperative day 180. Up to 180 days
complication rate	from the day of the surgery to the day of discharge. Up to 30 days
3-year disease-free survival	from the day of the surgery to the postoperative 3 years. Up to 3 years
3-year overall survival	from the day of the surgery to the postoperative 3 years. Up to 3 years

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Collaborators: Qilu Hospital of Shandong University; The First Affiliated Hospital of Zhengzhou University

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): November 30, 2027

Study Registration Dates

• First Submitted: September 28, 2024
• First Submitted That Met QC Criteria: October 22, 2024
• First Posted (Actual): October 23, 2024

Study Record Updates

• Last Update Posted (Actual): October 30, 2024
• Last Update Submitted That Met QC Criteria: October 26, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: video-assisted; robot-assisted; thymic epithelial tumor; thoracoscopic thymectomy
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Thoracic Neoplasms; Lymphatic Diseases; Neoplasms, Glandular and Epithelial; Thymus Neoplasms
• Other Study ID Numbers: KY2024455

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: National policy.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No