Subxiphoid VATS for Giant Mediastinal Teratoma

NCT ID: NCT07199699

Last Updated: 2025-09-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-01
• Study Completion Date: 2027-06-30

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 complications such as chest wall deformity. Currently, we have developed a new treatment method. We use a double retractor system to pull the upper and lower ends of the sternum, lifting it to obtain sufficient surgical space behind the sternum. This enables us to perform minimally invasive tumor resection through the subxiphoid approach with thoracoscopy. The advantages of this method include reduced surgical trauma and postoperative pain, shortened hospital stay, and improved cosmetic effect

Conditions

Teratomas; Mediastinal ( Chest) Masses; VATS

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Subxiphoid Minimally Invasive Resection Assisted by Double Sternal Elevation

Group Type: EXPERIMENTAL

Subxiphoid Minimally Invasive Resection of Giant Mediastinal Teratoma Assisted by Double Sternal Elevation

Intervention Type: PROCEDURE

All patients underwent minimally invasive mediastinal tumor resection using a double hook technique via the subxiphoid approach. The procedure was as follows: A 3-4 cm longitudinal incision was made below the xiphoid, and subcutaneous tissue was dissected to reach the anterior rectus sheath. The retroxiphoid space was bluntly dissected, and a thoracoscopic lens was inserted. A double-retractor system was placed in the subxiphoid and suprasternal regions, and retractor height was adjusted to aid in separating tumor adhesions from residual thymic tissue. Blunt dissection was used to separate the tumor from the innominate vein and phrenic nerve. After full tumor mobilization, it was placed into a sterile specimen bag and removed through the incision. The surgical area was rinsed and a mediastinal drainage tube was inserted, and the incision was closed layer by layer.

Interventions

Subxiphoid Minimally Invasive Resection of Giant Mediastinal Teratoma Assisted by Double Sternal Elevation

All patients underwent minimally invasive mediastinal tumor resection using a double hook technique via the subxiphoid approach. The procedure was as follows: A 3-4 cm longitudinal incision was made below the xiphoid, and subcutaneous tissue was dissected to reach the anterior rectus sheath. The retroxiphoid space was bluntly dissected, and a thoracoscopic lens was inserted. A double-retractor system was placed in the subxiphoid and suprasternal regions, and retractor height was adjusted to aid in separating tumor adhesions from residual thymic tissue. Blunt dissection was used to separate the tumor from the innominate vein and phrenic nerve. After full tumor mobilization, it was placed into a sterile specimen bag and removed through the incision. The surgical area was rinsed and a mediastinal drainage tube was inserted, and the incision was closed layer by layer.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Jiang Fan

Chief surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

20250612051346797

Identifier Type: -

Identifier Source: org_study_id