Subxiphoid VATS for Giant Mediastinal Teratoma
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-70
SponsorShanghai General Hospital, Shanghai Jiao Tong University School of Medicine
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Subxiphoid Minimally Invasive Resection of Giant Mediastinal Teratoma Assisted by Double Sternal Elevation
Procedure/SurgeryAll 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.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Subxiphoid Minimally Invasive Resection Assisted by Double Sternal ElevationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The incidence of intraoperative and postoperative complications
Time frame
From the start of the surgery to 30 days after the operationSecondary outcomes
1
Complete tumor resection rate
Time frame
From the start of the surgery to two weeks after the operation2
Postoperative function
The width of the incision scar (mm) and the Vancouver Scar Scale (VSS, 0-15 points) one month after the operation.
Time frame
From the start of the surgery to one month after the operation3
Postoperative Quality of life
The EuroQol Five Dimensions Questionnaire (EQ-5D) was used to assess the quality of life after the operation
Time frame
From the start of the surgery to six month after the operationLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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