TeratomasNCT07199699
Subxiphoid VATS for Giant Mediastinal Teratoma
A study testing Subxiphoid Minimally Invasive Resection of Giant Mediastinal Teratoma Assisted by Double Sternal Elevation in people with Teratomas and Mediastinal ( Chest) Masses, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 70 years
- Conditions the study is for
- Teratomas, Mediastinal ( Chest) Masses, VATS
- What is being tested?
- Subxiphoid Minimally Invasive Resection of Giant Mediastinal Teratoma Assisted by Double Sternal Elevation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2025to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: The Safety and Efficacy of Subxiphoid Minimally Invasive Resection of Giant Mediastinal Teratoma Assisted by Double Sternal Elevation
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
- Being tested
- Subxiphoid Minimally Invasive Resection of Giant Mediastinal Teratoma Assisted by Double Sternal Elevation
- Medical subject headings
- Teratoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subxiphoid Minimally Invasive Resection of Giant Mediastinal Teratoma Assisted by Double Sternal ElevationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Subxiphoid Minimally Invasive Resection Assisted by Double Sternal Elevation | Experimental | Not described Receives: Procedure: Subxiphoid Minimally Invasive Resection of Giant Mediastinal Teratoma Assisted by Double Sternal Elevation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of intraoperative and postoperative complications
Measured: From the start of the surgery to 30 days after the operation
Secondary outcomes (3)
Complete tumor resection rate
Measured: From the start of the surgery to two weeks after the operation
Postoperative function
The width of the incision scar (mm) and the Vancouver Scar Scale (VSS, 0-15 points) one month after the operation.
Measured: From the start of the surgery to one month after the operation
Postoperative Quality of life
The EuroQol Five Dimensions Questionnaire (EQ-5D) was used to assess the quality of life after the operation
Measured: From the start of the surgery to six month after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start1 Nov 2025 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TeratomasStudies of the same condition, open and under way.
- More trials run by Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiang Fan, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07199699
- Sponsor's protocol ID
- 20250612051346797
- Status last verified
- Sep 2025
- First submitted
- 24 Aug 2025
- Last updated
- 30 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of Subxiphoid Minimally Invasive Resection of Giant Mediastinal Teratoma Assisted by Double Sternal Elevation
- ClinicalTrials.gov ID
- NCT07199699
- Acronym / sponsor ID
- 20250612051346797
- Conditions
- Teratomas, Mediastinal ( Chest) Masses, VATS
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Nov 2025 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 30 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subxiphoid Minimally Invasive Resection Assisted by Double Sternal Elevation | Experimental | Procedure: Subxiphoid Minimally Invasive Resection of Giant Mediastinal Teratoma Assisted by Double Sternal Elevation |
Who may qualify
- Ages
- 10 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Subxiphoid Minimally Invasive Resection of Giant Mediastinal Teratoma Assisted by Double Sternal ElevationAll 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. | Procedure or surgery | Subxiphoid Minimally Invasive Resection Assisted by Double Sternal Elevation |
Primary outcome
The incidence of intraoperative and postoperative complications
Time frame: From the start of the surgery to 30 days after the operation
3 secondary outcomes
Complete tumor resection rate
Time frame: From the start of the surgery to two weeks after the operation
Postoperative function
Time frame: From the start of the surgery to one month after the operation
Postoperative Quality of life
Time frame: From the start of the surgery to six month after the operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Subxiphoid Minimally Invasive Resection of Giant Mediastinal Teratoma Assisted by Double Sternal Elevation in people with Teratomas and Mediastinal ( Chest) Masses, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of intraoperative and postoperative complications (time frame: From the start of the surgery to 30 days after the operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025.