ThymomaNCT03613272
The Curative Effect of Extended Thymectomy Performed Through Subxiphoid-right VATS Approach With Elevation of Sternum
A study testing Subxiphoid approach extended thymectomy by VATS and Intercostal approach extended thymectomy by VATS in people with Thymoma and Myasthenia Gravis, run by Jiang Fan at 5 sites in China.
Trial summary
Extended thymectomy is the main treatment for thymoma and other anterior mediastinal diseases. Video-assisted thoracic surgery(VATS) plays an important role in the surgery of extended thymectomy. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Thymoma, Myasthenia Gravis, Mediastinal Tumor
- What is being tested?
- Subxiphoid approach extended thymectomy by VATS and Intercostal approach extended thymectomy by VATS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 5 sitesChina
- Study dates
- 1 Jul 2018to 1 Dec 2023
- Phase
- Interventional
- 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 20 to 70 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
- Patients with normal cardio-pulmonary function before operation, BMI<30
Who cannot join
- Unable to tolerate surgery
- Masaoka staging Ⅲ-Ⅳ
- Patients who have undergone previous surgery or radiotherapy
- Myasthenia crisis
- Chronic pain or using opioid analgesics before surgery
- Preoperative mental disorders such as excessive anxiety
- Patients who underwent previous mediastinal surgery or cardiac surgery
- Patients with thoracic deformity
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
The Second Affiliated Hospital of Hainan Medical University
Haikou, Hainan, 570100
Biao Li, MD, libiao70@163.com
- Recruiting
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433
Jiang Fan, MD, +86 13764271861, drjiangfan@yahoo.com
Jiang Fan, MD
- Recruiting
Shaoxing Center Hospital
Shaoxing, Zhejiang, 312000
Xiaobing Li, MD, 2487400565@qq.com
- Recruiting
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, 030000
Rongsheng Zhang, MD, 17736924293@qq.com
- Recruiting
Taizhou Center Hospital (Taizhou Unoversity Hospital)
Taizhou, Zhejiang, 318000
Xuelin Zhang, MD, zxlmeet@126.com
About this study
Official title: A Prospective Multicenter Comparative Study of the Curative Effect of Extended Thymectomy Performed Through the Subxiphoid VATS Approach With Double Elevation of the Sternum Versus Intercostal VATS Approach
Extended thymectomy is the main treatment for thymoma and other anterior mediastinal diseases. Video-assisted thoracic surgery(VATS) plays an important role in the surgery of extended thymectomy. Now, VATS thymectomy through intercostal approach has been the commonly used minimally invasive surgical procedure for thymus surgery and is applied worldwide. But the intercostal approach may cause residue of thymus tissue and chronic pain. In 2013, doctor Marcin Zielin´ski form Poland reported a new technique of minimally invasive extended thymectomy performed through the VATS approach with double elevation of the sternum. And their early results proved this technique is probably the least invasive and the most complete technique of VATS thymectomy with excellent cosmetic results. Until now, doctor Jiang Fan form Shanghai Pulmonary Hospital has performed 50 cases extended thymectomy through the subxiphoid approach with double elevation of the sternum by VATS. This study is designed to compare the curative effect between this new method and traditional intercostal VATS.
Read the detailed description
This study is a prospective multicentre cohort study.The main study content is comparative study of the curative effect of extended thymectomy performed through the subxiphoid-right video-thoracoscopic approach with double elevation of the sternum versus intercostal video-thoracoscopic approach, divided into subxiphoid and intercostal groups. Communicating with the surgeon and patients who meet the inclusion criteria, decide whether to enter the subxiphoid or intercostal group. Subxiphoid group with subxiphoid-right video-thoracoscopic approach under double elevation of the sternum in extended thymectomy , intercostal group with traditional intercostal video-assisted thoracoscopic surgery in extended thymectomy. By collecting personal information of two groups of patients and the corresponding observation indicators to analyze whether the subxiphoid-right VATS approach with double elevation of the sternum is the least invasive and the most complete technique of VATS thymectomy.
- Conditions
- Thymoma, Myasthenia Gravis, Mediastinal Tumor
- Being tested
- Subxiphoid approach extended thymectomy by VATS, Intercostal approach extended thymectomy by VATS
- Keywords
- thymoma, thymectomy, Myasthenia Gravis, VATS, subxiphoid, elevation of the sternum, curative effect
- Medical subject headings
- Thymoma, Myasthenia Gravis, Mediastinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subxiphoid approach extended thymectomy by VATSProcedure or surgery
Extended thymectomy performed through the subxiphoid-right VATS approach with double elevation of the sternum
Intercostal approach extended thymectomy by VATSProcedure or surgery
Extended thymectomy performed through the traditional intercostal VATS approach
| Study group | Role | What they receive |
|---|---|---|
| Subxiphoid approach | Experimental | The patients in subxiphoid group will get subxiphoid approach extended thymectomy by VATS. Whole dissection was performed through a 4 to 7cm transverse subxiphoid incision, and a single 5-mm port was inserted into the right chest cavity for the video thoracoscope and subsequently for the chest tube. The sternum was elevated with two hooks connected to the sternal frame. The lower hook was inserted through the subxiphoid incision, and the superior hook was inserted percutaneously after the mediastinal tissue including the major mediastinal vessels was dissected from the inner surface of the sternum. The thymus and fatty tissue of the anterior mediastinum and the aorta-pulmonary window was completely removed. Receives: Procedure: Subxiphoid approach extended thymectomy by VATS |
| Intercostal approach | Experimental | The patients in intercostal group will get intercostal approach extended thymectomy by VATS. Receives: Procedure: Intercostal approach extended thymectomy by VATS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resection rate of thymus tissue
The thymus tissue resection rate was calculated by comparing the preoperative and postoperative CT images.
Measured: 1 month
Acute Pain Score
Visual analogue score (VAS-score) is to asses the development of acute pain after surgery. 11 point numeric rating scale of 0 represented "no pain"and a score of 10 represented "worst pain " in patients 24 hours after operation.
Measured: 24 hours
Life Quality of Patients
The EuroQol 5 Dimensions (EQ-5D) is used. EQ-5D is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life that can be used in a wide range of health conditions and treatments. EQ-5D includes self-reported quality of life, where 0 is the worst and 100 is the best imaginable health state.
Measured: 6 months
Myasthenia Gravis remission rate
The Quantitative Myasthenia Gravis scale (QMG) is used. It includes 13 items, such as eyelid ptosis, diplopia, eyelid closure, speech, swallowing, vital capacity, lift, grip and lower extremity elevation. QMG can evaluate myasthenia, and total score of the scale is from 0 (no myasthenia) to 39 (the most severe myasthenia). If the difference between the two assessment scores is greater than 3.5, it is considered that the symptoms of myasthenia gravis relieved.
Measured: 1 year
Disease-free survival
From grouping to the recurrence of disease or the time of death due to disease progression.
Measured: Up to 5 years
Recurrence rate
The rate of patients recurrence after surgery
Measured: Up to 5 years
Secondary outcomes (6)
Mortality rate
Death caused by operation or complications
Measured: Up to 5 years
Overall survival
From grouping to any cause of death
Measured: Up to 5 years
Operation time
Time of the surgical operation
Measured: 1 week
Length of stay
The time of the patients in hospital
Measured: 1 month
Complication rate
The incidence rate of postoperative complications in the two groups
Measured: 1 month
Chronic Pain Score
Visual analogue score (VAS-score) is to asses the development of chronic pain after surgery. 11 point numeric rating scale of 0 represented "no pain"and a score of 10 represented "worst pain " in patients 6 months after operation.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start1 Jul 2018
- Primary completion1 Jul 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ThymomaStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This study is a prospective multicentre cohort study.The main study content is comparative study of the curative effect of extended thymectomy performed through the subxiphoid-right video-thoracoscopic approach with double elevation of the sternum versus intercostal video-thoracoscopic approach, divided into subxiphoid and intercostal groups. Communicating with the surgeon and patients who meet the inclusion criteria, decide whether to enter the subxiphoid or intercostal group. Subxiphoid group with subxiphoid-right video-thoracoscopic approach under double elevation of the sternum in extended thymectomy , intercostal group with traditional intercostal video-assisted thoracoscopic surgery in extended thymectomy.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiang Fan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jiang Fan, Tongji University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03613272
- Sponsor's protocol ID
- K18-137
- Status last verified
- May 2021
- First submitted
- 7 Jul 2018
- Last updated
- 7 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zielinski M, Czajkowski W, Gwozdz P, Nabialek T, Szlubowski A, Pankowski J. Resection of thymomas with use of the new minimally-invasive technique of extended thymectomy performed through the subxiphoid-right video-thoracoscopic approach with double elevation of the sternum. Eur J Cardiothorac Surg. 2013 Aug;44(2):e113-9; discussion e119. doi: 10.1093/ejcts/ezt224. Epub 2013 Jun 12.
PubMed 23761413Zielinski M, Hauer L, Hauer J, Pankowski J, Nabialek T, Szlubowski A. Comparison of complete remission rates after 5 year follow-up of three different techniques of thymectomy for myasthenia gravis. Eur J Cardiothorac Surg. 2010 May;37(5):1137-43. doi: 10.1016/j.ejcts.2009.11.029. Epub 2010 Feb 8.
PubMed 20117014Friedant AJ, Handorf EA, Su S, Scott WJ. Minimally Invasive versus Open Thymectomy for Thymic Malignancies: Systematic Review and Meta-Analysis. J Thorac Oncol. 2016 Jan;11(1):30-8. doi: 10.1016/j.jtho.2015.08.004.
PubMed 26762737Takeo S, Sakada T, Yano T. Video-assisted extended thymectomy in patients with thymoma by lifting the sternum. Ann Thorac Surg. 2001 May;71(5):1721-3. doi: 10.1016/s0003-4975(00)02697-7.
PubMed 11383846Hess NR, Sarkaria IS, Pennathur A, Levy RM, Christie NA, Luketich JD. Minimally invasive versus open thymectomy: a systematic review of surgical techniques, patient demographics, and perioperative outcomes. Ann Cardiothorac Surg. 2016 Jan;5(1):1-9. doi: 10.3978/j.issn.2225-319X.2016.01.01.
PubMed 26904425
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Comparative Study of the Curative Effect of Extended Thymectomy Performed Through the Subxiphoid VATS Approach With Double Elevation of the Sternum Versus Intercostal VATS Approach
- ClinicalTrials.gov ID
- NCT03613272
- Acronym / sponsor ID
- K18-137
- Conditions
- Thymoma, Myasthenia Gravis, Mediastinal Tumor
- Keywords
- thymoma, thymectomy, Myasthenia Gravis, VATS, subxiphoid, elevation of the sternum, curative effect
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Jiang FanUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 3 Aug 2018 (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.
Extended thymectomy is the main treatment for thymoma and other anterior mediastinal diseases. Video-assisted thoracic surgery(VATS) plays an important role in the surgery of extended thymectomy. Now, VATS thymectomy through intercostal approach has been the commonly used minimally invasive surgical procedure for thymus surgery and is applied worldwide. But the intercostal approach may cause residue of thymus tissue and chronic pain. In 2013, doctor Marcin Zielin´ski form Poland reported a new technique of minimally invasive extended thymectomy performed through the VATS approach with double elevation of the sternum. And their early results proved this technique is probably the least invasive and the most complete technique of VATS thymectomy with excellent cosmetic results. Until now, doctor Jiang Fan form Shanghai Pulmonary Hospital has performed 50 cases extended thymectomy through the subxiphoid approach with double elevation of the sternum by VATS. This study is designed to compare the curative effect between this new method and traditional intercostal VATS.
Detailed description
This study is a prospective multicentre cohort study.The main study content is comparative study of the curative effect of extended thymectomy performed through the subxiphoid-right video-thoracoscopic approach with double elevation of the sternum versus intercostal video-thoracoscopic approach, divided into subxiphoid and intercostal groups. Communicating with the surgeon and patients who meet the inclusion criteria, decide whether to enter the subxiphoid or intercostal group. Subxiphoid group with subxiphoid-right video-thoracoscopic approach under double elevation of the sternum in extended thymectomy , intercostal group with traditional intercostal video-assisted thoracoscopic surgery in extended thymectomy. By collecting personal information of two groups of patients and the corresponding observation indicators to analyze whether the subxiphoid-right VATS approach with double elevation of the sternum is the least invasive and the most complete technique of VATS thymectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is a prospective multicentre cohort study.The main study content is comparative study of the curative effect of extended thymectomy performed through the subxiphoid-right video-thoracoscopic approach with double elevation of the sternum versus intercostal video-thoracoscopic approach, divided into subxiphoid and intercostal groups. Communicating with the surgeon and patients who meet the inclusion criteria, decide whether to enter the subxiphoid or intercostal group. Subxiphoid group with subxiphoid-right video-thoracoscopic approach under double elevation of the sternum in extended thymectomy , intercostal group with traditional intercostal video-assisted thoracoscopic surgery in extended thymectomy.
| Arm | Type | Receives |
|---|---|---|
| Subxiphoid approach | Experimental | Procedure: Subxiphoid approach extended thymectomy by VATSThe patients in subxiphoid group will get subxiphoid approach extended thymectomy by VATS. Whole dissection was performed through a 4 to 7cm transverse subxiphoid incision, and a single 5-mm port was inserted into the right chest cavity for the video thoracoscope and subsequently for the chest tube. The sternum was elevated with two hooks connected to the sternal frame. The lower hook was inserted through the subxiphoid incision, and the superior hook was inserted percutaneously after the mediastinal tissue including the major mediastinal vessels was dissected from the inner surface of the sternum. The thymus and fatty tissue of the anterior mediastinum and the aorta-pulmonary window was completely removed. |
| Intercostal approach | Experimental | Procedure: Intercostal approach extended thymectomy by VATSThe patients in intercostal group will get intercostal approach extended thymectomy by VATS. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- MG with thymic hyperplasia, thymoma or other anterior mediastinum disease
- Masaoka stagingⅠ-Ⅱ
- Patients with normal cardio-pulmonary function before operation, BMI<30
Key exclusion criteria (8 listed)
- Unable to tolerate surgery
- Masaoka staging Ⅲ-Ⅳ
- Patients who have undergone previous surgery or radiotherapy
- Myasthenia crisis
- Chronic pain or using opioid analgesics before surgery
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 approach extended thymectomy by VATSExtended thymectomy performed through the subxiphoid-right VATS approach with double elevation of the sternum | Procedure or surgery | Subxiphoid approach |
| Intercostal approach extended thymectomy by VATSExtended thymectomy performed through the traditional intercostal VATS approach | Procedure or surgery | Intercostal approach |
Primary outcome
Resection rate of thymus tissue
Time frame: 1 month
The thymus tissue resection rate was calculated by comparing the preoperative and postoperative CT images.
Acute Pain Score
Time frame: 24 hours
Visual analogue score (VAS-score) is to asses the development of acute pain after surgery. 11 point numeric rating scale of 0 represented "no pain"and a score of 10 represented "worst pain " in patients 24 hours after operation.
Life Quality of Patients
Time frame: 6 months
The EuroQol 5 Dimensions (EQ-5D) is used. EQ-5D is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life that can be used in a wide range of health conditions and treatments. EQ-5D includes self-reported quality of life, where 0 is the worst and 100 is the best imaginable health state.
Myasthenia Gravis remission rate
Time frame: 1 year
The Quantitative Myasthenia Gravis scale (QMG) is used. It includes 13 items, such as eyelid ptosis, diplopia, eyelid closure, speech, swallowing, vital capacity, lift, grip and lower extremity elevation. QMG can evaluate myasthenia, and total score of the scale is from 0 (no myasthenia) to 39 (the most severe myasthenia). If the difference between the two assessment scores is greater than 3.5, it is considered that the symptoms of myasthenia gravis relieved.
Disease-free survival
Time frame: Up to 5 years
From grouping to the recurrence of disease or the time of death due to disease progression.
Recurrence rate
Time frame: Up to 5 years
The rate of patients recurrence after surgery
6 secondary outcomes
Mortality rate
Time frame: Up to 5 years
Overall survival
Time frame: Up to 5 years
Operation time
Time frame: 1 week
Length of stay
Time frame: 1 month
Complication rate
Time frame: 1 month
Chronic Pain Score
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2021.
- Results publication: PubMed 23761413Zielinski M, Czajkowski W, Gwozdz P, Nabialek T, Szlubowski A, Pankowski J. Resection of thymomas with use of the new minimally-invasive technique of extended thymectomy performed through the subxiphoid-right video-thoracoscopic approach with double elevation of the sternum. Eur J Cardiothorac Surg. 2013 Aug;44(2):e113-9; discussion e119. doi: 10.1093/ejcts/ezt224. Epub 2013 Jun 12.
- Results publication: PubMed 20117014Zielinski M, Hauer L, Hauer J, Pankowski J, Nabialek T, Szlubowski A. Comparison of complete remission rates after 5 year follow-up of three different techniques of thymectomy for myasthenia gravis. Eur J Cardiothorac Surg. 2010 May;37(5):1137-43. doi: 10.1016/j.ejcts.2009.11.029. Epub 2010 Feb 8.
- Results publication: PubMed 26762737Friedant AJ, Handorf EA, Su S, Scott WJ. Minimally Invasive versus Open Thymectomy for Thymic Malignancies: Systematic Review and Meta-Analysis. J Thorac Oncol. 2016 Jan;11(1):30-8. doi: 10.1016/j.jtho.2015.08.004.
- Results publication: PubMed 11383846Takeo S, Sakada T, Yano T. Video-assisted extended thymectomy in patients with thymoma by lifting the sternum. Ann Thorac Surg. 2001 May;71(5):1721-3. doi: 10.1016/s0003-4975(00)02697-7.
- Results publication: PubMed 26904425Hess NR, Sarkaria IS, Pennathur A, Levy RM, Christie NA, Luketich JD. Minimally invasive versus open thymectomy: a systematic review of surgical techniques, patient demographics, and perioperative outcomes. Ann Cardiothorac Surg. 2016 Jan;5(1):1-9. doi: 10.3978/j.issn.2225-319X.2016.01.01.
- Individual participant dataSharing planned: Undecided
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subxiphoid approach extended thymectomy by VATS and Intercostal approach extended thymectomy by VATS in people with Thymoma and Myasthenia Gravis, run by Jiang Fan at 5 sites 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 8 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 7 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiang Fan, MD，PhD (+86 13764271861, drjiangfan@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resection rate of thymus tissue (time frame: 1 month). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03613272, which also lists 5 linked publications.
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 7 May 2021.