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Subxiphoid VATS for Giant Mediastinal Teratoma

The Safety and Efficacy of Subxiphoid Minimally Invasive Resection of Giant Mediastinal Teratoma Assisted by Double Sternal Elevation

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07199699
Enrollment
40
Registered
2025-09-30
Start date
2025-11-01
Completion date
2027-06-30
Last updated
2025-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mediastinal ( Chest) Masses, Teratomas, VATS

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

Interventions

PROCEDURESubxiphoid 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.

Sponsors

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
10 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
The incidence of intraoperative and postoperative complicationsFrom the start of the surgery to 30 days after the operation

Secondary

MeasureTime frameDescription
Complete tumor resection rateFrom the start of the surgery to two weeks after the operation
Postoperative functionFrom the start of the surgery to one month after the operationThe width of the incision scar (mm) and the Vancouver Scar Scale (VSS, 0-15 points) one month after the operation.
Postoperative Quality of lifeFrom the start of the surgery to six month after the operationThe EuroQol Five Dimensions Questionnaire (EQ-5D) was used to assess the quality of life after the operation

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026