Surgery for Masaoka-Koga I-II Thymoma

Fudan University

Status: Completed

Conditions: Thymoma; Masaoka Stage I; Masaoka Stage II

Treatments: Procedure: the subxiphoid approach thoracoscopic thymectomy; Procedure: the lateral intercostal approach thoracoscopic thymectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT05001113

B2021-454

Details and patient eligibility

About

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.

Full description

It is a multi-center, open, prospective randomized phase II&III clinical trial sponsored by Shanghai Zhongshan Hospital with other four hospitals in China participating in. 100 patients with thymoma (Masaoka-Koga I-II ) diagnosed by enhanced computed tomography were recruited and randomly assigned into the subxiphoid approach thoracoscopic thymectomy (SATT group) and the lateral intercostal approach thoracoscopic thymectomy (LATT group) according to the proportion of 1:1. The safety and perioperative outcomes are compared between the two surgical regimens.

Enrollment: 101 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Thymoma was diagnosed by chest enhanced CT (clinical stage: Masaoka Koga I-II);
2. The patients whose tumor diameter was <6 cm;
3. The patients with age ≥ 18 and ≤ 75 years old, the estimated survival time should be over 12 months;
4. ASA grade：1-2;
5. The patients should have no functional disorders in main organs.;
6. The patients should be able to understand our research and sign the informed consent.

Exclusion criteria

1. Imaging examination showed that the tumor had invasion of surrounding organs, pleural or pericardial dissemination, lymphatic or hematogenous metastasis;
2. Patients with myasthenia gravis;
3. Patients had undergone a sternotomy;
4. 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;
5. 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;
6. Female who is positive for serum pregnancy test or during lactation period;
7. The patients have history of organ transplantation (including autologous bone marrow transplantation and peripheral stem cell transplantation;
8. The patients have history of peripheral nerve system disorders, obvious mental disorders or central nerve system disorders;
9. The patients attend other clinical trials.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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101 participants in 2 patient groups

the subxiphoid approach thoracoscopic thymectomy

Experimental group

Description:

The subxiphoid approach thoracoscopic thymectomy is performed in enrolled patients.

Treatment:

Procedure: the subxiphoid approach thoracoscopic thymectomy

the lateral intercostal approach thoracoscopic thymectomy

Active Comparator group

Description:

The lateral intercostal approach thoracoscopic thymectomy is performed in enrolled patients.

Treatment:

Procedure: the lateral intercostal approach thoracoscopic thymectomy