LobectomyNCT03051438
The Feasibility and Advantages of Subxiphoid Uniportal Video-assisted Thoracoscopic Surgery in Pulmonary Lobectomy
A study testing Subxiphoid uniportal VATS and Three-port VATS in people with Lobectomy and Subxiphoid Uniportal Video-assisted Thoracoscopic Surgery, run by Xueying Yang at 1 site in China.
Trial summary
Uniportal video-assisted thoracoscopic surgery (VATS) lobectomy has emerged as a promising and exciting approach for minimally invasive thoracic surgery. However, nearly all reported uniportal VATS lobectomies have been performed via the intercostal route, and chest wall trauma has still occurred. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lobectomy, Subxiphoid Uniportal Video-assisted Thoracoscopic Surgery
- What is being tested?
- Subxiphoid uniportal VATS and Three-port VATS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to Jun 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with lung cancer can be undertook the subxiphoid uniportal VATS or three-port VATS
Who cannot join
- Contraindications in patients with lung cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Feasibility and Advantages of Subxiphoid Uniportal Video-assisted Thoracoscopic Surgery in Pulmonary Lobectomy.A Retrospective Study
Uniportal video-assisted thoracoscopic surgery (VATS) lobectomy has emerged as a promising and exciting approach for minimally invasive thoracic surgery. However, nearly all reported uniportal VATS lobectomies have been performed via the intercostal route, and chest wall trauma has still occurred. Here,the investigators undertook novel uniportal VATS technique involving a subxiphoid route for pulmonary lobectomies to evaluate the feasibility and advantages.
- Being tested
- Subxiphoid uniportal VATS, Three-port VATS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subxiphoid uniportal VATSProcedure or surgery
Patients were placed in a supine position, and the operating table was manipulated as needed to elevate the appropriate side of the body for surgery. The surgical procedures followed principles of pulmonary resections; in particular, similar to mediastinal lymphadenectomy for lung cancer, these procedures involved the individual dissection of veins, arteries and lobar bronchi.
Three-port VATSProcedure or surgery
The surgical procedures followed principles of pulmonary resections; in particular, similar to mediastinal lymphadenectomy for lung cancer, these procedures involved the individual dissection of veins, arteries and lobar bronchi
| Study group | Role | What they receive |
|---|---|---|
| Subxiphoid uniportal VATS | Other | retrospectively analyzed and compared perioperative data for patients who underwent subxiphoid uniportal and traditional three-port VATS lobectomies Receives: Procedure: Subxiphoid uniportal VATS |
| Three-port VATS | Other | retrospectively analyzed and compared perioperative data for patients who underwent subxiphoid uniportal and traditional three-port VATS lobectomies Receives: Procedure: Three-port VATS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
Measured: 17 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2017
- Study startJan 2016
- Primary completionJun 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for LobectomyStudies 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
- Participant, Investigator
- Enrolment
- 86 participants (estimated)
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
- NCT03051438
- Sponsor's protocol ID
- B451-1
- Status last verified
- May 2018
- First submitted
- 7 Feb 2017
- Last updated
- 24 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liu CC, Wang BY, Shih CS, Lin WC. Subxyphoid single-incision thoracoscopic pulmonary metastasectomy. Thorac Cancer. 2015 Mar;6(2):230-2. doi: 10.1111/1759-7714.12189. Epub 2015 Mar 2.
PubMed 26273365Liu CY, Lin CS, Liu CC. Subxiphoid single-incision thoracoscopic surgery for bilateral primary spontaneous pneumothorax. Wideochir Inne Tech Maloinwazyjne. 2015 Apr;10(1):125-8. doi: 10.5114/wiitm.2015.48572. Epub 2015 Jan 27.
PubMed 25960803Gonzalez-Rivas D, Yang Y, Lei J, Hernandez L, Jiang G. Subxiphoid uniportal video-assisted thoracoscopic middle lobectomy and anterior anatomic segmentectomy (S3). J Thorac Dis. 2016 Mar;8(3):540-3. doi: 10.21037/jtd.2016.02.63.
PubMed 27076952Hernandez-Arenas LA, Lin L, Yang Y, Liu M, Guido W, Gonzalez-Rivas D, Jiang G, Jiang L. Initial experience in uniportal subxiphoid video-assisted thoracoscopic surgery for major lung resections. Eur J Cardiothorac Surg. 2016 Dec;50(6):1060-1066. doi: 10.1093/ejcts/ezw189. Epub 2016 Jul 11.
PubMed 27401700Song N, Zhao DP, Jiang L, Bao Y, Jiang GN, Zhu YM, Ding JA. Subxiphoid uniportal video-assisted thoracoscopic surgery (VATS) for lobectomy: a report of 105 cases. J Thorac Dis. 2016 Mar;8(Suppl 3):S251-7. doi: 10.3978/j.issn.2072-1439.2016.02.32.
PubMed 27014471Liu CC, Wang BY, Shih CS, Liu YH. Subxiphoid single-incision thoracoscopic left upper lobectomy. J Thorac Cardiovasc Surg. 2014 Dec;148(6):3250-1. doi: 10.1016/j.jtcvs.2014.08.033. Epub 2014 Aug 23. No abstract available.
PubMed 25240526Yang X, Wang L, Zhang C, Zhao D, Lu Y, Wang Z. The Feasibility and Advantages of Subxiphoid Uniportal Video-Assisted Thoracoscopic Surgery in Pulmonary Lobectomy. World J Surg. 2019 Jul;43(7):1841-1849. doi: 10.1007/s00268-019-04948-6.
PubMed 31065773
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility and Advantages of Subxiphoid Uniportal Video-assisted Thoracoscopic Surgery in Pulmonary Lobectomy.A Retrospective Study
- ClinicalTrials.gov ID
- NCT03051438
- Acronym / sponsor ID
- B451-1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Xueying YangUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 13 Feb 2017 (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.
Uniportal video-assisted thoracoscopic surgery (VATS) lobectomy has emerged as a promising and exciting approach for minimally invasive thoracic surgery. However, nearly all reported uniportal VATS lobectomies have been performed via the intercostal route, and chest wall trauma has still occurred. Here,the investigators undertook novel uniportal VATS technique involving a subxiphoid route for pulmonary lobectomies to evaluate the feasibility and advantages.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subxiphoid uniportal VATS | Other | Procedure: Subxiphoid uniportal VATSretrospectively analyzed and compared perioperative data for patients who underwent subxiphoid uniportal and traditional three-port VATS lobectomies |
| Three-port VATS | Other | Procedure: Three-port VATSretrospectively analyzed and compared perioperative data for patients who underwent subxiphoid uniportal and traditional three-port VATS lobectomies |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with lung cancer can be undertook the subxiphoid uniportal VATS or three-port VATS
Key exclusion criteria (1 listed)
- Contraindications in patients with lung cancer
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 uniportal VATSPatients were placed in a supine position, and the operating table was manipulated as needed to elevate the appropriate side of the body for surgery. The surgical procedures followed principles of pulmonary resections; in particular, similar to mediastinal lymphadenectomy for lung cancer, these procedures involved the individual dissection of veins, arteries and lobar bronchi. | Procedure or surgery | Subxiphoid uniportal VATS |
| Three-port VATSThe surgical procedures followed principles of pulmonary resections; in particular, similar to mediastinal lymphadenectomy for lung cancer, these procedures involved the individual dissection of veins, arteries and lobar bronchi | Procedure or surgery | Three-port VATS |
Primary outcome
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
Time frame: 17 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2018.
- Results publication: PubMed 26273365Liu CC, Wang BY, Shih CS, Lin WC. Subxyphoid single-incision thoracoscopic pulmonary metastasectomy. Thorac Cancer. 2015 Mar;6(2):230-2. doi: 10.1111/1759-7714.12189. Epub 2015 Mar 2.
- Results publication: PubMed 25960803Liu CY, Lin CS, Liu CC. Subxiphoid single-incision thoracoscopic surgery for bilateral primary spontaneous pneumothorax. Wideochir Inne Tech Maloinwazyjne. 2015 Apr;10(1):125-8. doi: 10.5114/wiitm.2015.48572. Epub 2015 Jan 27.
- Results publication: PubMed 27076952Gonzalez-Rivas D, Yang Y, Lei J, Hernandez L, Jiang G. Subxiphoid uniportal video-assisted thoracoscopic middle lobectomy and anterior anatomic segmentectomy (S3). J Thorac Dis. 2016 Mar;8(3):540-3. doi: 10.21037/jtd.2016.02.63.
- Results publication: PubMed 27401700Hernandez-Arenas LA, Lin L, Yang Y, Liu M, Guido W, Gonzalez-Rivas D, Jiang G, Jiang L. Initial experience in uniportal subxiphoid video-assisted thoracoscopic surgery for major lung resections. Eur J Cardiothorac Surg. 2016 Dec;50(6):1060-1066. doi: 10.1093/ejcts/ezw189. Epub 2016 Jul 11.
- Results publication: PubMed 27014471Song N, Zhao DP, Jiang L, Bao Y, Jiang GN, Zhu YM, Ding JA. Subxiphoid uniportal video-assisted thoracoscopic surgery (VATS) for lobectomy: a report of 105 cases. J Thorac Dis. 2016 Mar;8(Suppl 3):S251-7. doi: 10.3978/j.issn.2072-1439.2016.02.32.
- Results publication: PubMed 25240526Liu CC, Wang BY, Shih CS, Liu YH. Subxiphoid single-incision thoracoscopic left upper lobectomy. J Thorac Cardiovasc Surg. 2014 Dec;148(6):3250-1. doi: 10.1016/j.jtcvs.2014.08.033. Epub 2014 Aug 23. No abstract available.
- Derived from this study: PubMed 31065773Yang X, Wang L, Zhang C, Zhao D, Lu Y, Wang Z. The Feasibility and Advantages of Subxiphoid Uniportal Video-Assisted Thoracoscopic Surgery in Pulmonary Lobectomy. World J Surg. 2019 Jul;43(7):1841-1849. doi: 10.1007/s00268-019-04948-6.
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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 Subxiphoid uniportal VATS and Three-port VATS in people with Lobectomy and Subxiphoid Uniportal Video-assisted Thoracoscopic Surgery, 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: status not confirmed, as of the sponsor's last update on 24 May 2018. 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?
Results are not available in the source record.
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?
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment (time frame: 17 months). 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 NCT03051438, which also lists 7 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 24 May 2018.