ThymectomyPhase 23-HoleNCT02317224
The Safety and Efficacy of "3-Hole" Subxiphorid Approach in the Treatment of Anterior Mediastinal Tumor
A Phase 2 study testing "3-Hole" subxiphorid and subcostal approach, Trans sternal approach and VATS approach in people with Thymectomy and Myasthenia Gravis, run by Tang-Du Hospital at 1 site in China.
Trial summary
Surgery plays an important role in the treatment of anterior mediastinum disease. The major surgical approaches include: cervical approach, mid-sternal approach, cervical combined mid-sternal approach and video-assisted thoracoscopic approach. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Thymectomy, Myasthenia Gravis
- What is being tested?
- "3-Hole" subxiphorid and subcostal approach, Trans sternal approach and VATS approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- Aug 2014to Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- MG with thymic hyperplasia, thymoma or other anterior mediastinum disease
- Masaoka stagingⅠ-Ⅱ
- Thymoma without MG
- Mass diameter <10cm
- Inform Consent Form is signed
Who cannot join
- Unable to tolerate surgery
- myasthenic crisis
- Masaoka staging Ⅲ-Ⅳ
- Patients who have undergone previous surgery or radiotherapy
- pregnancy , breastfeeding or younger than 18 years old
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tangdu hospital
Xi'an, Shaanxi, 710038
Yongan Zhou, MD, +86 029 84717544, zhou.yongan@163.com
Qiang Lu, MD, +86 029 84717548, luqianglu@126.com
About this study
Official title: Comparison of Safety and Efficacy Among "3-Hole" Subxiphorid Approach, Trans Sternal Approach and VATS in Surgical Treatment of Anterior Mediastinal Tumor
Surgery plays an important role in the treatment of anterior mediastinum disease. The major surgical approaches include: cervical approach, mid-sternal approach, cervical combined mid-sternal approach and video-assisted thoracoscopic approach. The cervical approach is rarely adopted because of its restricted visual field. The cervical combined mid-sternal approach have a broader field of vision, given this advantage, the surgeon can remove the thymus and its surrounding fat tissue more thoroughly. But the trauma of this approach is much larger, and the postoperative complication is also a serious problem. The video-assisted thoracoscope is often adopted by left or right approach, this minimally invasive procedure can not remove anterior mediastinum fat thoroughly. In clinical practice, the investigators designed a new method named "3-Hole" subxiphoid approach. This study is designed to compare the safety and validity between this new method and others.
- Conditions
- Thymectomy, Myasthenia Gravis
- Being tested
- "3-Hole" subxiphorid and subcostal approach, Trans sternal approach, VATS approach
- Keywords
- 3-Hole approach, extended thymectomy, myasthenia gravis, safety, effectiveness
- Medical subject headings
- Myasthenia Gravis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"3-Hole" subxiphorid and subcostal approachProcedure or surgery
Also called 3-Hole approach
"3-Hole" subxiphorid and subcostal approach anterior mediastinum tumor resection
Trans sternal approachProcedure or surgery
Also called median sternotomy
Trans sternal approach anterior mediastinum tumor resection
VATS approachProcedure or surgery
Also called Video-assisted thoracoscope
Video-assisted thoracoscope anterior mediastinum tumor resection
| Study group | Role | What they receive |
|---|---|---|
| "3-Hole" subxiphorid and subcostal approach | Experimental | The patient were in the supine position with legs apart at about 45°, made a 2.0 cm incision below xiphoid process as the observation hole. Then made two 0.5cm operation holes along bilateral rib arch at midclavicular line, two trocars were inserted into the two holes under the guidance of B-ultrasound.After that, carbon dioxide was pumped into the anterior mediastinum, the pressure was maintained at 8 mmH2O, ultrasound scalpel and a grasping forceps were inserted through the operating ports respectively. Retrosternal space including bilateral lower poles of thymus, internal mammary arteries and phrenic nerves were exposed by both blunt and sharp dissection. Then ultrasound scalpel were used to separate the thymus and its surrounding fat tissue, cut off thymic veins by ultrasound scalpel.For patients with myasthenia gravis, bilateral mediastinal pleurae and the affected adipose tissues had been thoroughly removed. Receives: Procedure: "3-Hole" subxiphorid and subcostal approach |
| Trans sternal approach | Experimental | Not described Receives: Procedure: Trans sternal approach |
| VATS approach | Experimental | Not described Receives: Procedure: VATS approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of bleeding
Measured by the difference between the wet weight and dry weight of surgical gauze
Measured: Participants will be followed for the duration of hospital stay, an expected average of 5 days
Rate of conversions to thoracotomy
Only in "3-Hole" subxiphorid group and VATS group
Measured: Participants will be followed for the duration of hospital stay, an expected average of 5 days
Duration of operation
Measured: Participants will be followed for the duration of hospital stay, an expected average of 5 days
Mortality rate
Death caused by operation or complications
Measured: up to 10 years
Overall survival
From randomization to any cause of death
Measured: up to 10 years
Quality of life
Measured by EORTC QLQ-C30 (version 3) scale
Measured: up to 10 years after operation
Number of Participants with Adverse Events
Measured: up to 8weekss afte operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2014 (estimated)
- Study startAug 2014
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThymectomyStudies of the same condition, open and under way.
- More trials run by Tang-Du HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongan Zhou, Tang-Du Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02317224
- Sponsor's protocol ID
- TangduH717544
- Acronym
- 3-Hole
- Status last verified
- Dec 2014
- First submitted
- 26 Nov 2014
- Last updated
- 15 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Safety and Efficacy Among "3-Hole" Subxiphorid Approach, Trans Sternal Approach and VATS in Surgical Treatment of Anterior Mediastinal Tumor
- ClinicalTrials.gov ID
- NCT02317224
- Acronym / sponsor ID
- 3-Hole / TangduH717544
- Conditions
- Thymectomy, Myasthenia Gravis
- Keywords
- 3-Hole approach, extended thymectomy, myasthenia gravis, safety, effectiveness
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 15 Dec 2014 (estimated)
- 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.
Surgery plays an important role in the treatment of anterior mediastinum disease. The major surgical approaches include: cervical approach, mid-sternal approach, cervical combined mid-sternal approach and video-assisted thoracoscopic approach. The cervical approach is rarely adopted because of its restricted visual field. The cervical combined mid-sternal approach have a broader field of vision, given this advantage, the surgeon can remove the thymus and its surrounding fat tissue more thoroughly. But the trauma of this approach is much larger, and the postoperative complication is also a serious problem. The video-assisted thoracoscope is often adopted by left or right approach, this minimally invasive procedure can not remove anterior mediastinum fat thoroughly. In clinical practice, the investigators designed a new method named "3-Hole" subxiphoid approach. This study is designed to compare the safety and validity between this new method and others.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| "3-Hole" subxiphorid and subcostal approach | Experimental | Procedure: "3-Hole" subxiphorid and subcostal approachThe patient were in the supine position with legs apart at about 45°, made a 2.0 cm incision below xiphoid process as the observation hole. Then made two 0.5cm operation holes along bilateral rib arch at midclavicular line, two trocars were inserted into the two holes under the guidance of B-ultrasound.After that, carbon dioxide was pumped into the anterior mediastinum, the pressure was maintained at 8 mmH2O, ultrasound scalpel and a grasping forceps were inserted through the operating ports respectively. Retrosternal space including bilateral lower poles of thymus, internal mammary arteries and phrenic nerves were exposed by both blunt and sharp dissection. Then ultrasound scalpel were used to separate the thymus and its surrounding fat tissue, cut off thymic veins by ultrasound scalpel.For patients with myasthenia gravis, bilateral mediastinal pleurae and the affected adipose tissues had been thoroughly removed. |
| Trans sternal approach | Experimental | Procedure: Trans sternal approach |
| VATS approach | Experimental | Procedure: VATS approach |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- MG with thymic hyperplasia, thymoma or other anterior mediastinum disease
- Masaoka stagingⅠ-Ⅱ
- Thymoma without MG
- Mass diameter <10cm
- Inform Consent Form is signed
Key exclusion criteria (5 listed)
- Unable to tolerate surgery
- myasthenic crisis
- Masaoka staging Ⅲ-Ⅳ
- Patients who have undergone previous surgery or radiotherapy
- pregnancy , breastfeeding or younger than 18 years old
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 |
|---|---|---|
| "3-Hole" subxiphorid and subcostal approachAlso: 3-Hole approach"3-Hole" subxiphorid and subcostal approach anterior mediastinum tumor resection | Procedure or surgery | "3-Hole" subxiphorid and subcostal approach |
| Trans sternal approachAlso: median sternotomyTrans sternal approach anterior mediastinum tumor resection | Procedure or surgery | Trans sternal approach |
| VATS approachAlso: Video-assisted thoracoscopeVideo-assisted thoracoscope anterior mediastinum tumor resection | Procedure or surgery | VATS approach |
Primary outcome
Amount of bleeding
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days
Measured by the difference between the wet weight and dry weight of surgical gauze
Rate of conversions to thoracotomy
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days
Only in "3-Hole" subxiphorid group and VATS group
Duration of operation
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days
Mortality rate
Time frame: up to 10 years
Death caused by operation or complications
Overall survival
Time frame: up to 10 years
From randomization to any cause of death
Quality of life
Time frame: up to 10 years after operation
Measured by EORTC QLQ-C30 (version 3) scale
Number of Participants with Adverse Events
Time frame: up to 8weekss afte operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2014.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing "3-Hole" subxiphorid and subcostal approach, Trans sternal approach and VATS approach in people with Thymectomy and Myasthenia Gravis, run by Tang-Du Hospital at 1 site in China.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 15 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yong-an Zhou, MD (+86 029 84717544, zhou.yongan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of bleeding (time frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days). The study lists 7 primary outcomes in all. 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 15 Dec 2014; AzTrials last refreshed its copy on 8 Nov 2026.