Surgery for Masaoka-Koga I-II Thymoma

NCT ID: NCT05001113

Last Updated: 2022-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-15
• Study Completion Date: 2022-08-17

Brief 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.

Detailed 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.

Conditions

Thymoma; Masaoka Stage I; Masaoka Stage II

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

the subxiphoid approach thoracoscopic thymectomy

The subxiphoid approach thoracoscopic thymectomy is performed in enrolled patients.

Group Type: EXPERIMENTAL

the subxiphoid approach thoracoscopic thymectomy

Intervention Type: PROCEDURE

A 2-cm straight incision was made in the middle of the xiphoid process, the incision was used as a thoracoscope hole, and the xiphoid process could be removed if necessary. The surgeon used the oval forceps to release the left and right soft tissue gaps behind the sternum, from the anterior mediastinum tunnel. Two 0.5 cm extrapleural thoracic ports under the bilateral costal arches were created, and this incision was used as an operation hole. The thread puncture cone with a diameter of 0.5 cm was placed under the guidance of the finger.

the lateral intercostal approach thoracoscopic thymectomy

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

Group Type: ACTIVE_COMPARATOR

the lateral intercostal approach thoracoscopic thymectomy

Intervention Type: PROCEDURE

Right-side approach: Use the left supine position. The observing port was created at the right axillary midline line in the fourth intercostal space, and the other two ports were made as to the operation hole along the anterior axillary lines in the third and fifth intercostal spaces.

Left-side approach: Use the right supine position. The observing port was created at the left axillary midline line in the fourth intercostal space, and the other two ports were made as to the operation hole along the anterior axillary lines in the third and fifth intercostal spaces.

Interventions

the subxiphoid approach thoracoscopic thymectomy

A 2-cm straight incision was made in the middle of the xiphoid process, the incision was used as a thoracoscope hole, and the xiphoid process could be removed if necessary. The surgeon used the oval forceps to release the left and right soft tissue gaps behind the sternum, from the anterior mediastinum tunnel. Two 0.5 cm extrapleural thoracic ports under the bilateral costal arches were created, and this incision was used as an operation hole. The thread puncture cone with a diameter of 0.5 cm was placed under the guidance of the finger.

Intervention Type: PROCEDURE

the lateral intercostal approach thoracoscopic thymectomy

Right-side approach: Use the left supine position. The observing port was created at the right axillary midline line in the fourth intercostal space, and the other two ports were made as to the operation hole along the anterior axillary lines in the third and fifth intercostal spaces.

Left-side approach: Use the right supine position. The observing port was created at the left axillary midline line in the fourth intercostal space, and the other two ports were made as to the operation hole along the anterior axillary lines in the third and fifth intercostal spaces.

Intervention Type: PROCEDURE

Other Intervention Names

SATT; LATT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhongshan Hospital (Xiamen), Fudan University

OTHER

Sponsor Role: collaborator

Xuhui Central Hospital, Shanghai

OTHER

Sponsor Role: collaborator

Shanghai Minhang Central Hospital

OTHER

Sponsor Role: collaborator

Shanghai Qingpu Central Hospital

UNKNOWN

Sponsor Role: collaborator

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lijie Tan, MD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Zhongshan Hospital

Locations

Shanghai Zhongshan Hospital

Shanghai, , China

Countries

China

Other Identifiers

B2021-454

Identifier Type: -

Identifier Source: org_study_id