RATT Vs. VATT for Early-stage TETs

October 26, 2024 updated by: Shanghai Zhongshan Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Postoperative draingage volume
Time Frame: Up to 7 days.
Postoperative draingage volume is the total draingage volume after surgery.
Up to 7 days.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
complete recestion rate
Time Frame: Up to 7 days.
Up to 7 days.
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.
From the time at start of the surgery to the time at end of the surgery. Up to 7 days.
operative time
Time Frame: From the time at start of the surgery to the time at end of the surgery. Up to 7 days.
From the time at start of the surgery to the time at end of the surgery. Up to 7 days.
bleeding volume
Time Frame: From the time at start of the surgery to the time at end of the surgery. Up to 7 days.
From the time at start of the surgery to the time at end of the surgery. Up to 7 days.
duration of drainage
Time Frame: from the day of the surgery to the day of removal of drainage tubes. Up to 7 days.
from the day of the surgery to the day of removal of drainage tubes. Up to 7 days.
postoperative hospital stays
Time Frame: from the day of the surgery to the day of discharge. Up to 30 days
from the day of the surgery to the day of discharge. Up to 30 days
re-operation rate
Time Frame: from the day of the surgery to the day of discharge. Up to 7 days
from the day of the surgery to the day of discharge. Up to 7 days
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
from the day of the surgery to the day of discharge. Up to 7 days
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
from the day of the surgery to the day of discharge. Up to 7 days
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
from the day of the surgery to the day of discharge. Up to 7 days
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
from the day of the surgery to the day of discharge. Up to 7 days
serum procalcitonin level at postoperaive day 1
Time Frame: from the day of the surgery to the day of discharge. Up to 7 days
from the day of the surgery to the day of discharge. Up to 7 days
serum procalcitonin level at postoperaive day 2
Time Frame: from the day of the surgery to the day of discharge. Up to 7 days
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
Time Frame: from the day of the surgery to the postoperative day 7. Up to 7 days
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
Time Frame: from the day of the surgery to the postoperative day 180. Up to 180 days
from the day of the surgery to the postoperative day 180. Up to 180 days
complication rate
Time Frame: from the day of the surgery to the day of discharge. Up to 30 days
from the day of the surgery to the day of discharge. Up to 30 days
3-year disease-free survival
Time Frame: from the day of the surgery to the postoperative 3 years. Up to 3 years
from the day of the surgery to the postoperative 3 years. Up to 3 years
3-year overall survival
Time Frame: from the day of the surgery to the postoperative 3 years. Up to 3 years
from the day of the surgery to the postoperative 3 years. Up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Zhongshan Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Qilu Hospital of Shandong University
The First Affiliated Hospital of Zhengzhou University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 28, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 22, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 23, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 30, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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