Mediastinal TumorNCT03537430
Totally no Tube (TNT) Uniportal Video-assisted Thoracoscopic Surgery (VATS) VS Traditional Uniportal VATS for Mediastinal Tumor
A study testing TNT uniportal VATS mediastinal tumor resection and Traditional uniportal VATS mediastinal tumor resection in people with Mediastinal Tumor, run by Xueying Yang at 1 site in China.
Trial summary
TNT surgery is a new area of exploration and evolution in thoracic minimal invasive surgery. TNT Uniportal Video-assisted Thoracoscopic Surgery (VATS) has become popular during mediastinal tumors resection. However, there has been little randomized controlled trials into the associated feasibility and advantage. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Mediastinal Tumor
- What is being tested?
- TNT uniportal VATS mediastinal tumor resection and Traditional uniportal VATS mediastinal tumor resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2018to 20 Aug 2019
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The trial recruited patients aged from 18 to 75 years with a diagnosis of mediastinal tumor. Preoperative chest CT examination showed that shape of the mediastinal tumor was regular, boundary was clear, and maximum diameter of the mass was less than 4 cm. Other inclusion criteria included capability of giving consent and adequate organ function to tolerate uniportal thoracoscopy mediastinal tumor resection.
Who cannot join
- Preoperative examination showed that the tumor invaded the surrounding blood vessels, pericardium, lung and other tissues or had distant metastasis; preoperative complications include severe coronary heart disease, arrhythmia and other serious cardiopulmonary diseases; large masses, difficult surgical procedures; manifestations of myasthenia gravis; hypovolemia, blood disorders, or abnormal clotting mechanism; pulmonary function and arterial blood gas analysis showed that patients could not tolerate surgery; previous thoracotomy; inability to obtain consent. Furthermore, the exclusion criteria were defifined as follows: intraoperative pleural adhesion or technical challenge to achieve hemostasis that make conversion from VATS to thoracotomy; clinician decides the patient should not continue the trial according to individual condition; patient withdraws from the trial.
Trial locations and contacts
1 site in 1 country.
China1 site
The Fourth Affiliated Hospital of China Medical University
Shenyang, Liaoning, 110004
About this study
Official title: Totally no Tube (TNT) Uniportal Video-assisted Thoracoscopic Surgery (VATS) VS Traditional Uniportal VATS for Mediastinal Tumor: A Prospective Randomized Controlled Trial
TNT surgery is a new area of exploration and evolution in thoracic minimal invasive surgery. TNT Uniportal Video-assisted Thoracoscopic Surgery (VATS) has become popular during mediastinal tumors resection. However, there has been little randomized controlled trials into the associated feasibility and advantage. The aim of our RCT was to evaluate the feasibility and advantage of TNT Uniportal VATS for mediastinal tumors resection and its significance in Fast Track Surgery (FTS). This is a single-center prospective randomized controlled trial. 98 patients aged between 18 and 75 years with clinically mediastinal tumors were randomly assigned to two groups, 50 patients received TNT uniportal VATS mediastinal tumor resection (TNT group) and 48 patients underwent traditional uniportal VATS mediastinal tumor resection (control group), the short-term perioperative outcomes would be reported here.
Read the detailed description
This study was designed as a single-center prospective randomized controlled trial. The trial recruited patients aged from 18 to 75 years with a diagnosis of mediastinal tumor. Preoperative chest CT examination showed that shape of the mediastinal tumor was regular, boundary was clear, and maximum diameter of the mass was less than 4 cm. Other inclusion criteria included capability of giving consent and adequate organ function to tolerate uniportal thoracoscopy mediastinal tumor resection. The exclusion criteria are described as follows: preoperative examination showed that the tumor invaded the surrounding blood vessels, pericardium, lung and other tissues or had distant metastasis; preoperative complications include severe coronary heart disease, arrhythmia and other serious cardiopulmonary diseases; large masses, difficult surgical procedures; manifestations of myasthenia gravis; hypovolemia, blood disorders, or abnormal clotting mechanism; pulmonary function and arterial blood gas analysis showed that patients could not tolerate surgery; previous thoracotomy; inability to obtain consent. Furthermore, the exclusion criteria were defifined as follows: intraoperative pleural adhesion or technical challenge to achieve hemostasis that make conversion from VATS to thoracotomy; clinician decides the patient should not continue the trial according to individual condition; patient withdraws from the trial. According to International Conference on Harmonisation, all participants gave written informed consent. Our RCT was launched in April 2018, which conducted in accordance with the Declaration of Helsinki and good clinical practice according to the International Conference on Harmonization guidelines. The ethics committee of The Fourth Affiliated Hospital of Medical Sciences, Liaoning, China, approved this study (approval number: EC-2018-HS-01).
After eligibility had been confirmed and inform consents obtained, the investigator registered patients to ensure allocation concealment. Next we randomly enrolled patients to TNT group and control group in accordance with a list of randomization numbers. This list was generated in the trial statistician's computer. Allocation was communicated by telephone by the trial coordinator. Neither patients nor any investigators were masked to treatment allocation.
The patients underwent routine physical examination, hematologic and biochemical tests, arterial blood gas analysis, pulmonary function test and computed tomography. Uniportal VATS mediastinal tumor resection was the standard surgical intervention according to the protocol. Patients in TNT group underwent TNT uniportal VATS mediastinal tumor resection, patients in control group underwent traditional uniportal VATS. Pre-, peri-, and postoperative details and outcome variables of patients were collected.
- Conditions
- Mediastinal Tumor
- Being tested
- TNT uniportal VATS mediastinal tumor resection, Traditional uniportal VATS mediastinal tumor resection
- Keywords
- TNT (Totally no tube), uniportal VATS, mediastinal tumor
- Medical subject headings
- Mediastinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TNT uniportal VATS mediastinal tumor resectionProcedure or surgery
TNT uniportal video-assisted thoracoscopic surgery refers to the use of conventional uniportal video-assisted thoracoscopic surgery, the use of laryngeal mask anesthesia instead of tracheal intubation anesthesia, intraoperative catheter was not retained, postoperative chest catheter placement.
Traditional uniportal VATS mediastinal tumor resectionProcedure or surgery
The surgical procedures followed principles of mediastinal tumor resection，uniportal video-assisted thoracoscopic surgery in mediastinal tumor resection.
| Study group | Role | What they receive |
|---|---|---|
| TNT Uniportal Video-assisted Thoracoscopic Surgery | Other | This group of patients underwent TNT uniportal VATS mediastinal tumor resection Receives: Procedure: TNT uniportal VATS mediastinal tumor resection |
| Uniportal Video-assisted Thoracoscopic Surgery | Other | This group of patients underwent traditional uniportal VATS mediastinal tumor resection Receives: Procedure: Traditional uniportal VATS mediastinal tumor resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
operative time
Anesthesia completed to the end of the operation
Measured: 1 day
Intubation/laryngeal mask completion time
Intubation/laryngeal mask completion time
Measured: 1 day
duration of postoperative pain
Postoperative pain duration
Measured: 10 days
VAS pain scores
The VAS pain score was given to patients and the pain scores were recorded at 6h, 12h, 24h, 48h, and 72h postoperatively.
Measured: 5 days
Intraoperative blood loss
Intraoperative blood loss
Measured: 1 day
The time of early ambulation after operation
The time from the patient's postoperative pushback to the first bedtime
Measured: 1 day
Postoperative hospital stay
Postoperative hospital stay
Measured: 15 days
hospitalization expenses
The total cost of hospitalization
Measured: 15 days
Intraoperative oxygen saturation, SpO2
Intraoperative oxygen saturation, SpO2
Measured: 1 day
Intraoperative mean arterial pressure, MAP
Intraoperative mean arterial pressure, MAP
Measured: 1 day
postoperative complication rate
Incidence of postoperative complications such as respiratory, cardiovascular and intubation-related complications
Measured: 15 days
Intraoperative heart rate, HR
Intraoperative heart rate, HR
Measured: 1 day
Postoperative extubation time
Postoperative extubation time
Measured: 1 day
Postoperative feeding time
Postoperative feeding time
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2018
- Study start1 Apr 2018
- Primary completion15 Aug 2019
- Study completion20 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Mediastinal TumorStudies 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
- Model description
- This is a single-center prospective randomized controlled trial. 98 patients aged between 18 and 75 years with clinically mediastinal tumors were randomly assigned to two groups, 50 patients received TNT uniportal VATS mediastinal tumor resection (TNT group) and 48 patients underwent traditional uniportal VATS mediastinal tumor resection (control group), the short-term perioperative outcomes would be reported here.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xueying Yang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xueying Yang, Shengjing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03537430
- Sponsor's protocol ID
- EC-2018-HS-001
- Status last verified
- Aug 2019
- First submitted
- 15 May 2018
- Last updated
- 22 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhao ZR, Lau RWH, Ng CSH. Anaesthesiology for uniportal VATS: double lumen, single lumen and tubeless. J Vis Surg. 2017 Aug 21;3:108. doi: 10.21037/jovs.2017.07.05. eCollection 2017.
PubMed 29078668Petersen RH, Holbek BL, Hansen HJ, Kehlet H. Video-assisted thoracoscopic surgery-taking a step into the future. Eur J Cardiothorac Surg. 2017 Apr 1;51(4):694-695. doi: 10.1093/ejcts/ezw381. No abstract available.
PubMed 28007878Mineo TC, Tamburrini A, Perroni G, Ambrogi V. 1000 cases of tubeless video-assisted thoracic surgery at the Rome Tor Vergata University. Future Oncol. 2016 Dec;12(23s):13-18. doi: 10.2217/fon-2016-0348. Epub 2016 Sep 30.
PubMed 27686131Cui F, Liu J, Li S, Yin W, Xin X, Shao W, He J. Tubeless video-assisted thoracoscopic surgery (VATS) under non-intubated, intravenous anesthesia with spontaneous ventilation and no placement of chest tube postoperatively. J Thorac Dis. 2016 Aug;8(8):2226-32. doi: 10.21037/jtd.2016.08.02.
PubMed 27621880Gonzalez-Rivas D, Yang Y, Guido W, Jiang G. Non-intubated (tubeless) uniportal video-assisted thoracoscopic lobectomy. Ann Cardiothorac Surg. 2016 Mar;5(2):151-3. doi: 10.21037/acs.2016.03.02. No abstract available.
PubMed 27134844Fernandes P, Lareiro S, Vouga L, Guerra M, Miranda J. Uniportal Video-Assisted Thorascoscopic Surgery - The New Paradigm in the Surgical Treatment of Lung Cancer. Rev Port Cir Cardiotorac Vasc. 2017 Jul-Dec;24(3-4):127.
PubMed 29701369Migliore M. Uniportal video-assisted thoracic surgery, and the uni-surgeon: new words for the contemporary world. J Vis Surg. 2018 Mar 7;4:45. doi: 10.21037/jovs.2018.02.11. eCollection 2018.
PubMed 29682455Bedetti B, Solli P, Lawrence D, Panagiotopoulos N, Hayward M, Scarci M. Single port video-assisted thoracoscopic thymectomy. J Vis Surg. 2016 Sep 1;2:149. doi: 10.21037/jovs.2016.08.07. eCollection 2016.
PubMed 29078536Ooi A, Sibayan M. Uniportal video assisted thoracoscopic surgery thymectomy (right approach). J Vis Surg. 2016 Jan 17;2:13. doi: 10.3978/j.issn.2221-2965.2015.12.14. eCollection 2016.
PubMed 29078441Ooi A, Qiang F. Uniportal video assisted thoracoscopic surgery thymectomy (left approach). J Vis Surg. 2016 Jan 16;2:12. doi: 10.3978/j.issn.2221-2965.2015.12.18. eCollection 2016.
PubMed 29078440Dunning J. Video-assisted thoracoscopic microthymectomy. Ann Cardiothorac Surg. 2015 Nov;4(6):550-5. doi: 10.3978/j.issn.2225-319X.2015.11.04.
PubMed 26693152
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Totally no Tube (TNT) Uniportal Video-assisted Thoracoscopic Surgery (VATS) VS Traditional Uniportal VATS for Mediastinal Tumor: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03537430
- Acronym / sponsor ID
- EC-2018-HS-001
- Conditions
- Mediastinal Tumor
- Keywords
- TNT (Totally no tube), uniportal VATS, mediastinal tumor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Xueying YangUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 15 Aug 2019 (actual)
- Study completion
- 20 Aug 2019 (actual)
- First posted
- 25 May 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.
TNT surgery is a new area of exploration and evolution in thoracic minimal invasive surgery. TNT Uniportal Video-assisted Thoracoscopic Surgery (VATS) has become popular during mediastinal tumors resection. However, there has been little randomized controlled trials into the associated feasibility and advantage. The aim of our RCT was to evaluate the feasibility and advantage of TNT Uniportal VATS for mediastinal tumors resection and its significance in Fast Track Surgery (FTS). This is a single-center prospective randomized controlled trial. 98 patients aged between 18 and 75 years with clinically mediastinal tumors were randomly assigned to two groups, 50 patients received TNT uniportal VATS mediastinal tumor resection (TNT group) and 48 patients underwent traditional uniportal VATS mediastinal tumor resection (control group), the short-term perioperative outcomes would be reported here.
Detailed description
This study was designed as a single-center prospective randomized controlled trial. The trial recruited patients aged from 18 to 75 years with a diagnosis of mediastinal tumor. Preoperative chest CT examination showed that shape of the mediastinal tumor was regular, boundary was clear, and maximum diameter of the mass was less than 4 cm. Other inclusion criteria included capability of giving consent and adequate organ function to tolerate uniportal thoracoscopy mediastinal tumor resection. The exclusion criteria are described as follows: preoperative examination showed that the tumor invaded the surrounding blood vessels, pericardium, lung and other tissues or had distant metastasis; preoperative complications include severe coronary heart disease, arrhythmia and other serious cardiopulmonary diseases; large masses, difficult surgical procedures; manifestations of myasthenia gravis; hypovolemia, blood disorders, or abnormal clotting mechanism; pulmonary function and arterial blood gas analysis showed that patients could not tolerate surgery; previous thoracotomy; inability to obtain consent. Furthermore, the exclusion criteria were defifined as follows: intraoperative pleural adhesion or technical challenge to achieve hemostasis that make conversion from VATS to thoracotomy; clinician decides the patient should not continue the trial according to individual condition; patient withdraws from the trial. According to International Conference on Harmonisation, all participants gave written informed consent. Our RCT was launched in April 2018, which conducted in accordance with the Declaration of Helsinki and good clinical practice according to the International Conference on Harmonization guidelines. The ethics committee of The Fourth Affiliated Hospital of Medical Sciences, Liaoning, China, approved this study (approval number: EC-2018-HS-01).
After eligibility had been confirmed and inform consents obtained, the investigator registered patients to ensure allocation concealment. Next we randomly enrolled patients to TNT group and control group in accordance with a list of randomization numbers. This list was generated in the trial statistician's computer. Allocation was communicated by telephone by the trial coordinator. Neither patients nor any investigators were masked to treatment allocation.
The patients underwent routine physical examination, hematologic and biochemical tests, arterial blood gas analysis, pulmonary function test and computed tomography. Uniportal VATS mediastinal tumor resection was the standard surgical intervention according to the protocol. Patients in TNT group underwent TNT uniportal VATS mediastinal tumor resection, patients in control group underwent traditional uniportal VATS. Pre-, peri-, and postoperative details and outcome variables of patients were collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a single-center prospective randomized controlled trial. 98 patients aged between 18 and 75 years with clinically mediastinal tumors were randomly assigned to two groups, 50 patients received TNT uniportal VATS mediastinal tumor resection (TNT group) and 48 patients underwent traditional uniportal VATS mediastinal tumor resection (control group), the short-term perioperative outcomes would be reported here.
| Arm | Type | Receives |
|---|---|---|
| TNT Uniportal Video-assisted Thoracoscopic Surgery | Other | Procedure: TNT uniportal VATS mediastinal tumor resectionThis group of patients underwent TNT uniportal VATS mediastinal tumor resection |
| Uniportal Video-assisted Thoracoscopic Surgery | Other | Procedure: Traditional uniportal VATS mediastinal tumor resectionThis group of patients underwent traditional uniportal VATS mediastinal tumor resection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The trial recruited patients aged from 18 to 75 years with a diagnosis of mediastinal tumor. Preoperative chest CT examination showed that shape of the mediastinal tumor was regular, boundary was clear, and maximum diameter of the mass was less than 4 cm. Other inclusion criteria included capability of giving consent and adequate organ function to tolerate uniportal thoracoscopy mediastinal tumor resection.
Key exclusion criteria (1 listed)
- Preoperative examination showed that the tumor invaded the surrounding blood vessels, pericardium, lung and other tissues or had distant metastasis; preoperative complications include severe coronary heart disease, arrhythmia and other serious cardiopulmonary diseases; large masses, difficult surgical procedures; manifestations of myasthenia gravis; hypovolemia, blood disorders, or abnormal clotting mechanism; pulmonary function and arterial blood gas analysis showed that patients could not tolerate surgery; previous thoracotomy; inability to obtain consent. Furthermore, the exclusion criteria were defifined as follows: intraoperative pleural adhesion or technical challenge to achieve hemostasis that make conversion from VATS to thoracotomy; clinician decides the patient should not continue the trial according to individual condition; patient withdraws from the trial.
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 |
|---|---|---|
| TNT uniportal VATS mediastinal tumor resectionTNT uniportal video-assisted thoracoscopic surgery refers to the use of conventional uniportal video-assisted thoracoscopic surgery, the use of laryngeal mask anesthesia instead of tracheal intubation anesthesia, intraoperative catheter was not retained, postoperative chest catheter placement. | Procedure or surgery | TNT Uniportal Video-assisted Thoracoscopic Surgery |
| Traditional uniportal VATS mediastinal tumor resectionThe surgical procedures followed principles of mediastinal tumor resection，uniportal video-assisted thoracoscopic surgery in mediastinal tumor resection. | Procedure or surgery | Uniportal Video-assisted Thoracoscopic Surgery |
Primary outcome
operative time
Time frame: 1 day
Anesthesia completed to the end of the operation
Intubation/laryngeal mask completion time
Time frame: 1 day
Intubation/laryngeal mask completion time
duration of postoperative pain
Time frame: 10 days
Postoperative pain duration
VAS pain scores
Time frame: 5 days
The VAS pain score was given to patients and the pain scores were recorded at 6h, 12h, 24h, 48h, and 72h postoperatively.
Intraoperative blood loss
Time frame: 1 day
Intraoperative blood loss
The time of early ambulation after operation
Time frame: 1 day
The time from the patient's postoperative pushback to the first bedtime
Postoperative hospital stay
Time frame: 15 days
Postoperative hospital stay
hospitalization expenses
Time frame: 15 days
The total cost of hospitalization
Intraoperative oxygen saturation, SpO2
Time frame: 1 day
Intraoperative oxygen saturation, SpO2
Intraoperative mean arterial pressure, MAP
Time frame: 1 day
Intraoperative mean arterial pressure, MAP
postoperative complication rate
Time frame: 15 days
Incidence of postoperative complications such as respiratory, cardiovascular and intubation-related complications
Intraoperative heart rate, HR
Time frame: 1 day
Intraoperative heart rate, HR
Postoperative extubation time
Time frame: 1 day
Postoperative extubation time
Postoperative feeding time
Time frame: 1 day
Postoperative feeding time
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2019.
- Results publication: PubMed 29078668Zhao ZR, Lau RWH, Ng CSH. Anaesthesiology for uniportal VATS: double lumen, single lumen and tubeless. J Vis Surg. 2017 Aug 21;3:108. doi: 10.21037/jovs.2017.07.05. eCollection 2017.
- Results publication: PubMed 28007878Petersen RH, Holbek BL, Hansen HJ, Kehlet H. Video-assisted thoracoscopic surgery-taking a step into the future. Eur J Cardiothorac Surg. 2017 Apr 1;51(4):694-695. doi: 10.1093/ejcts/ezw381. No abstract available.
- Results publication: PubMed 27686131Mineo TC, Tamburrini A, Perroni G, Ambrogi V. 1000 cases of tubeless video-assisted thoracic surgery at the Rome Tor Vergata University. Future Oncol. 2016 Dec;12(23s):13-18. doi: 10.2217/fon-2016-0348. Epub 2016 Sep 30.
- Results publication: PubMed 27621880Cui F, Liu J, Li S, Yin W, Xin X, Shao W, He J. Tubeless video-assisted thoracoscopic surgery (VATS) under non-intubated, intravenous anesthesia with spontaneous ventilation and no placement of chest tube postoperatively. J Thorac Dis. 2016 Aug;8(8):2226-32. doi: 10.21037/jtd.2016.08.02.
- Results publication: PubMed 27134844Gonzalez-Rivas D, Yang Y, Guido W, Jiang G. Non-intubated (tubeless) uniportal video-assisted thoracoscopic lobectomy. Ann Cardiothorac Surg. 2016 Mar;5(2):151-3. doi: 10.21037/acs.2016.03.02. No abstract available.
- Results publication: PubMed 29701369Fernandes P, Lareiro S, Vouga L, Guerra M, Miranda J. Uniportal Video-Assisted Thorascoscopic Surgery - The New Paradigm in the Surgical Treatment of Lung Cancer. Rev Port Cir Cardiotorac Vasc. 2017 Jul-Dec;24(3-4):127.
- Results publication: PubMed 29682455Migliore M. Uniportal video-assisted thoracic surgery, and the uni-surgeon: new words for the contemporary world. J Vis Surg. 2018 Mar 7;4:45. doi: 10.21037/jovs.2018.02.11. eCollection 2018.
- Results publication: PubMed 29078536Bedetti B, Solli P, Lawrence D, Panagiotopoulos N, Hayward M, Scarci M. Single port video-assisted thoracoscopic thymectomy. J Vis Surg. 2016 Sep 1;2:149. doi: 10.21037/jovs.2016.08.07. eCollection 2016.
- Results publication: PubMed 29078441Ooi A, Sibayan M. Uniportal video assisted thoracoscopic surgery thymectomy (right approach). J Vis Surg. 2016 Jan 17;2:13. doi: 10.3978/j.issn.2221-2965.2015.12.14. eCollection 2016.
- Results publication: PubMed 29078440Ooi A, Qiang F. Uniportal video assisted thoracoscopic surgery thymectomy (left approach). J Vis Surg. 2016 Jan 16;2:12. doi: 10.3978/j.issn.2221-2965.2015.12.18. eCollection 2016.
- Results publication: PubMed 26693152Dunning J. Video-assisted thoracoscopic microthymectomy. Ann Cardiothorac Surg. 2015 Nov;4(6):550-5. doi: 10.3978/j.issn.2225-319X.2015.11.04.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TNT uniportal VATS mediastinal tumor resection and Traditional uniportal VATS mediastinal tumor resection in people with Mediastinal Tumor, run by Xueying Yang 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 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: finished, as of the sponsor's last update on 22 Aug 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
operative time (time frame: 1 day). The study lists 14 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 NCT03537430, which also lists 11 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 22 Aug 2019.