Surgery for Masaoka-Koga I-II Thymoma (NCT05001113) | Clinical Trial Compass
CompletedNot Applicable
Surgery for Masaoka-Koga I-II Thymoma
China101 participantsStarted 2021-08-15
Plain-language summary
The purpose of this study was to evaluate the safety and perioperative outcomes of the subxiphoid approach versus the lateral intercostal approach thoracoscopic thymectomy for Masaoka-Koga I-II thymoma.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Thymoma was diagnosed by chest enhanced CT (clinical stage: Masaoka Koga I-II);
. The patients whose tumor diameter was \<6 cm;
. The patients with age ≥ 18 and ≤ 75 years old, 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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Dosage of analgesic medication after surgery
Timeframe: Up to the date of hospital discharge since the data of completion of surgery, up to 7 days
2
Visual Analog Scales scores for postoperative pain
Timeframe: Up to the date of hospital discharge since the data of completion of surgery, up to 7 days
3
Postoperative hospital stay
Timeframe: Up to the date of meeting the criteria of hospital discharge since the data of surgery, up to 1 month
. 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;