ThymectomyNCT04223466
Video-assisted Thoracoscopic Thymectomy Versus Subxiphoid Procedure
A study testing Subxiphoid surgery procedure and VATS surgery procedure in people with Thymectomy, run by The Second Hospital of Shandong University at 1 site in China.
Trial summary
Surgerys used in thymectomy for myasthenia gravis and anterior mediastinal tumours have become much less invasive in recent years. In our study, the surgical technique which resected the thymus below the xiphoid process and the technique which was regarded as conventional video- assisted thoracoscopic surgery (VATS)… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Thymectomy
- What is being tested?
- Subxiphoid surgery procedure and VATS surgery procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 7 Jan 2020to 31 Dec 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Thymoma with or without myasthenia gravis；
- Generalized myasthenia gravis not sensitive to conservative medicine treatment;
- Good cardiopulmonary function.
Who cannot join
- Cardiopulmonary function can't bear surgery;
- Generalized myasthenia gravis with MuSK(+).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Yunpeng
Jinan, Shandong, 250033
Yunpeng, +8618766188692, zyp_baggio@163.com
About this study
Official title: Video-assisted Thoracoscopic Thymectomy Versus Subxiphoid Thymectomy: Short- Term and Long- Term Results
Surgerys used in thymectomy for myasthenia gravis and anterior mediastinal tumours have become much less invasive in recent years. In our study, the surgical technique which resected the thymus below the xiphoid process and the technique which was regarded as conventional video- assisted thoracoscopic surgery (VATS) thymectomy was compared.
- Conditions
- Thymectomy
- Being tested
- Subxiphoid surgery procedure, VATS surgery procedure
- Keywords
- Video-assisted thoracoscopic surgery, Subxiphoid approach
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subxiphoid surgery procedureProcedure or surgery
Subxiphoid procedure for thymectomy
VATS surgery procedureProcedure or surgery
VATS procedure for thymectomy
| Study group | Role | What they receive |
|---|---|---|
| Subxiphoid group | Experimental | Subxiphoid procedure for thymectomy. Receives: Procedure: Subxiphoid surgery procedure |
| VATS group | Active comparator | Video-assisted thoracoscopic thymectomy through chest wall. Receives: Procedure: VATS surgery procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale of postoperative pain
in score
Measured: within 3 days
Operation time
in minutes
Measured: one day
The amount of blood loss
in milliliter
Measured: one day
Duration of drainage
in days
Measured: with 7 days
Duration of hospital stay
in days
Measured: with 7 days
Secondary outcomes (3)
Complete remission rates
Complete remission rates after 5 year follow-up of thymectomy for myasthenia gravis
Measured: 5 years
Recurrence rate
Recurrence rate after 5 year follow-up of thymectomy for thymoma
Measured: 5 years
Overall survival
Overall survival in rate
Measured: within 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2020
- Study start7 Jan 2020
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2027 (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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04223466
- Sponsor's protocol ID
- Subxiphoid ZYP1
- Status last verified
- Nov 2022
- First submitted
- 8 Jan 2020
- Last updated
- 16 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video-assisted Thoracoscopic Thymectomy Versus Subxiphoid Thymectomy: Short- Term and Long- Term Results
- ClinicalTrials.gov ID
- NCT04223466
- Acronym / sponsor ID
- Subxiphoid ZYP1
- Conditions
- Thymectomy
- Keywords
- Video-assisted thoracoscopic surgery, Subxiphoid approach
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Second Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 7 Jan 2020 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 10 Jan 2020 (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.
Surgerys used in thymectomy for myasthenia gravis and anterior mediastinal tumours have become much less invasive in recent years. In our study, the surgical technique which resected the thymus below the xiphoid process and the technique which was regarded as conventional video- assisted thoracoscopic surgery (VATS) thymectomy was compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subxiphoid group | Experimental | Procedure: Subxiphoid surgery procedureSubxiphoid procedure for thymectomy. |
| VATS group | Active comparator | Procedure: VATS surgery procedureVideo-assisted thoracoscopic thymectomy through chest wall. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Thymoma with or without myasthenia gravis；
- Generalized myasthenia gravis not sensitive to conservative medicine treatment;
- Good cardiopulmonary function.
Key exclusion criteria (2 listed)
- Cardiopulmonary function can't bear surgery;
- Generalized myasthenia gravis with MuSK(+).
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 surgery procedureSubxiphoid procedure for thymectomy | Procedure or surgery | Subxiphoid group |
| VATS surgery procedureVATS procedure for thymectomy | Procedure or surgery | VATS group |
Primary outcome
Visual Analogue Scale of postoperative pain
Time frame: within 3 days
in score
Operation time
Time frame: one day
in minutes
The amount of blood loss
Time frame: one day
in milliliter
Duration of drainage
Time frame: with 7 days
in days
Duration of hospital stay
Time frame: with 7 days
in days
3 secondary outcomes
Complete remission rates
Time frame: 5 years
Recurrence rate
Time frame: 5 years
Overall survival
Time frame: within 10 years
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 16 Nov 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subxiphoid surgery procedure and VATS surgery procedure in people with Thymectomy, run by The Second Hospital of Shandong University 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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 16 Nov 2022. 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.
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?
Contact Yunpeng Zhao (+8618766188692, zyp_baggio@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale of postoperative pain (time frame: within 3 days). The study lists 5 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 16 Nov 2022.