Status:

NOT_YET_RECRUITING

Subxiphoid VATS for Giant Mediastinal Teratoma

Lead Sponsor:

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Conditions:

Teratomas

Mediastinal ( Chest) Masses

Eligibility:

All Genders

10-70 years

Phase:

NA

Brief Summary

For giant mediastinal teratomas, the only treatment option available is usually open-chest surgery, which causes significant trauma, leads to obvious postoperative pain and may result in long-term com...

Eligibility Criteria

Inclusion

  • Age: 10 - 70 years old, gender unrestricted; Preoperative enhanced CT or MRI confirms anterior mediastinal mass with the maximum diameter ≥ 7 cm; Intraoperative frozen section pathology confirms teratoma (mature or immature type); American Society of Anesthesiologists (ASA) classification grade I - III, with acceptable cardiopulmonary function for single-lung ventilation; No severe thoracic deformity or severe adhesion in the posterior mediastinum (assessed by preoperative imaging); Patients voluntarily sign the informed consent form, understanding the purpose and potential risks of the study.

Exclusion

  • Tumors invading major blood vessels (such as the innominate vein, superior vena cava, or aorta) or the pericardium require combined vascular/pericardial resection and reconstruction; Tumors crossing the midline and encasing the trachea or esophagus require multidisciplinary joint surgery; Previous mediastinal surgery or radiotherapy history, leading to local anatomical structure disorder; Coagulation dysfunction (INR \> 1.5 or platelet count \< 50×10⁹/L); Severe immune deficiency (such as HIV infection, long-term glucocorticoid treatment); Pregnant or lactating women; Concurrent other malignant tumors (metastatic lesions need to be excluded); Severe cardiopulmonary diseases (such as COPD GOLD Ⅲ-Ⅳ grade, NYHA cardiac function Ⅲ-Ⅳ grade); Mental illness or cognitive impairment that cannot cooperate with postoperative follow-up; Participated in other clinical trials that may interfere with the results of this study.

Key Trial Info

Start Date :

November 1 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

June 30 2027

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT07199699

Start Date

November 1 2025

End Date

June 30 2027

Last Update

September 30 2025

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