Video Assisted Thoracic Surgery (VATS)NCT03997799
Comparison of Two Techniques of Uniportal VATS Lobectomies for Clinical Stage I Non-Small Cell Lung Cancer
A study testing uniportal lobectomy with complete lymphadenectomy in people with Video Assisted Thoracic Surgery (VATS) and Non-Small Cell Lung Cancer (NSCLC), run by Pulmonary Hospital Zakopane at 1 site in Poland.
Trial summary
Aim of the study is to compare safety and tolerance of two techniques of Video Assisted Thoracic Surgery (VATS) uniportal lobectomies in the prospective randomized single-institutional trial. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Video Assisted Thoracic Surgery (VATS), Non-Small Cell Lung Cancer (NSCLC)
- What is being tested?
- uniportal lobectomy with complete lymphadenectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePoland
- Study dates
- 10 Jun 2019to 31 Jul 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histologically, or cytologically proven clinical stage I (cI) NSCLC
Who cannot join
- Patients with more advanced NSCLC than clinical stage I (cI) NSCLC
- Severe atherosclerotic lesions of the innominate artery and the aortic arch and previous cardiac surgery.
- Severe pleural adhesions and calcified intrapulmonary nodes after previous tuberculosis are also technical obstacles for this kind of surgery.
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Pulmonary Hospital
Zakopane, 34-500
Marcin Zielinski, MD Phd, +48182015045 ext. 179, marcinz@mp.pl
Marcin Zielinski, MD Phd, 0048182015045 ext. 0048182015045, marcinz@mp.pl
About this study
Official title: Comparison of Two Techniques of Video Assisted Thoracic Surgery (VATS) Uniportal Lobectomies Through the Transcervical and Standard Intercostal Approaches for Clinical Stage I Non-Small Cell Lung Cancer (NSCLC) in the Prospective Randomized Single-institutional Trial
Aim of the study is to compare safety and tolerance of two techniques of Video Assisted Thoracic Surgery (VATS) uniportal lobectomies in the prospective randomized single-institutional trial. One arm is a uniportal lobectomy performed through the transcervical approach with elevation of the sternum, the other arm will utilize a standard uniportal intercostal approache. There will be 10 patients in each group. Patients in clinical stage cI-III (T1-3N0-2M0) Non-Small Cell Lung Cancer (NSCLC). The results will be compared for time of the procedure, number of conversions to multi-portal VATS and/or open thoracotomy, duration and volume of chest drainage, amount of postoperatve pain, time of hospitalization and the number of resected lymph nodes and metastatic nodes. Accrual of patients is planned to complete within 12 months.
Read the detailed description
Introduction Video-assisted thoracoscopic surgery (VATS) pulmonary lobectomy became an accepted method for the treatment of early-stage Non-Small-Cell Lung Cancer (NSCLC). There are several variants of VATS lobectomy. In recent years the uniportal approach described by Gonzales-Rivas gained a world-wide interest. The uniportal VATS approach can be performed through the intercostal incision as has been practiced in vast majority of published cases, but there is also another approach, namely the transcervical one, first described by Zakopane team in 2007. In that time, right upper lobectomy and afterwards the left upper lobectomy through the transcervical approach combined with single-port intercostal VATS were performed. The method was to combine lobectomy with Transcervical Extended Mediastinal Lymphadenectomy (TEMLA), preceding a pulmonary resection with intraoperative examination of the mediastinal nodes with the imprint cytology technique. From 2016, after adopting the technique of uniportal intercostal lobectomy, transcervical VATS uniportal lobectomies, without additional intercostal ports were performed. Now, resection of any rightsided or left-sided lobe with the transcervical approach are feasible to be performed.
Surgical Technique Preparation The patient is positioned supine on the operating table with a roll placed beneath the thoracic spine to elevate the chest and to hyperextend the patient's neck. Under general anaesthesia an endobronchial tube is inserted to conduct selective lung ventilation during the latter part of the procedure.
A transverse 6-8 cm transcervical collar incision is made in the neck in a standard way with division and suture-ligation of the anterior jugular veins bilaterally. The sternal manubrium is elevated with sharp one-tooth hook connected to the Zakopane II frame (Aesculap-Chifa, BBraun, Nowy Tomysl, Poland) to widen the access to the mediastinum. The first part of the procedure is TEMLA. The technique of this procedure, and possible pitfalls and the methods of management of intraoperative complications were published elsewhere [6]. In brief, the technique of TEMLA included dissection of all mediastinal nodal stations except for the pulmonary ligaments nodes (station 9). The subcarinal nodes, the periesophageal nodes, the right and left lower paratracheal nodes, and the right hilar nodes (stations 7, 8, 4R, 4L and 10R) were removed in the mediastinoscopy-assisted technique and the paraaortic and the pulmonary-window nodes (stations 6 and 5) are removed in the videothoracoscopy-assisted technique, with the videothoracoscope inserted through the transcervical incision. The superior mediastnal nodes and upper right and left paratracheal nodes (stations 1, 2R and 2L) are removed in the open surgery fashion under direct eye control. The prevascular and retrotracheal nodes (stations 3A and 3P) are removed in pre-selective cases. Generally, the mediastinal pleura is not violated and no drain is left in the mediastinum. Bilateral supraclavicular lymphadenectomy and even deep cervical lymph node dissection is possible during TEMLA through the same incision.
The nodes removed during TEMLA are sent sequentially to intraoperative pathologic examination with use of the imprint cytology technique [4]. The imprint cytology technique is a highly reliable technique much less time consuming than a frozen section analysis. Due to this advantage the time of nodal examinations adds only 15 to 20 minutes to the total time of the operation. After receiving the negative results of the imprint cytology, confirming there are no nodal metastasis the VATS lobectomy part starts. The position of the patient is slightly changed with the introduction of the roll beneath the patient's operating side. Additionally, the operating table is rotated to achieve a semi-lateral position of the patient. The ventillation of the operated lung is disconnected and the mediastinal pleura is opened. Further dissection is performed with the use of endostaplers to manage the lobar vesselts, bronchus and interlobar fissures.
- Being tested
- uniportal lobectomy with complete lymphadenectomy
- Keywords
- lung cancer, mediastinum, pulmonary resection
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
uniportal lobectomy with complete lymphadenectomyProcedure or surgery
uniportal lobectomy with complete lymphadenectomy
| Study group | Role | What they receive |
|---|---|---|
| uniportal transcervical approache | Experimental | Uniportal lobectomy with complete lymphadenectomy - transcervical approach with elevation of the sternum Receives: Procedure: uniportal lobectomy with complete lymphadenectomy |
| uniportal intercostal approache | Experimental | Uniportal lobectomy with complete lymphadenectomy - intercostal approache Receives: Procedure: uniportal lobectomy with complete lymphadenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
time of the procedure
duration of the operation in minutes
Measured: 4 weeks
number of conversions to multi-portal VATS and/or open thoracotomy
number of conversions to multi-portal VATS and/or open thoracotomy
Measured: 4 weeks
duration of chest drainage
duration of chest drainage in days
Measured: 4 weeks
volume of chest drainage
volume of chest drainage in ml
Measured: 4 weeks
amount of postoperatve pain
1.pain intensity 0-100 mm VAS scale measured every 4 hours on standard ruler beginning from the end of the surgery.
The visual analogue scale (VAS) is commonly used as the outcome measure for such studies. It is usually presented as a 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of "no pain at all" and "worst pain imaginable." Its simplicity, reliability, and validity, as well as its ratio scale properties, make the VAS the optimal tool for describing pain severity or intensity.
Measured: up to 72 hours after the end of surgery
time of hospitalization
time of hospitalization in days
Measured: 4 weeks
number of resected lymph nodes
number of resected lymph nodes
Measured: 4 weeks
number of resected metastatic nodes
number of resected metastatic nodes
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2019
- Study start10 Jun 2019
- Primary completion10 Jun 2019
- Study completion31 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Video Assisted Thoracic Surgery (VATS)Studies 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
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pulmonary Hospital Zakopane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marcin Zielinski, MD PhD, Study director, Pulmonary Hospital Zakopane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03997799
- Sponsor's protocol ID
- 01/2019
- Status last verified
- Apr 2022
- First submitted
- 18 Jun 2019
- Last updated
- 26 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Techniques of Video Assisted Thoracic Surgery (VATS) Uniportal Lobectomies Through the Transcervical and Standard Intercostal Approaches for Clinical Stage I Non-Small Cell Lung Cancer (NSCLC) in the Prospective Randomized Single-institutional Trial
- ClinicalTrials.gov ID
- NCT03997799
- Acronym / sponsor ID
- 01/2019
- Keywords
- lung cancer, mediastinum, pulmonary resection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Pulmonary Hospital ZakopaneUniversity, hospital or other
- Study start
- 10 Jun 2019 (actual)
- Primary completion
- 10 Jun 2019 (actual)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 25 Jun 2019 (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.
Aim of the study is to compare safety and tolerance of two techniques of Video Assisted Thoracic Surgery (VATS) uniportal lobectomies in the prospective randomized single-institutional trial. One arm is a uniportal lobectomy performed through the transcervical approach with elevation of the sternum, the other arm will utilize a standard uniportal intercostal approache. There will be 10 patients in each group. Patients in clinical stage cI-III (T1-3N0-2M0) Non-Small Cell Lung Cancer (NSCLC). The results will be compared for time of the procedure, number of conversions to multi-portal VATS and/or open thoracotomy, duration and volume of chest drainage, amount of postoperatve pain, time of hospitalization and the number of resected lymph nodes and metastatic nodes. Accrual of patients is planned to complete within 12 months.
Detailed description
Introduction Video-assisted thoracoscopic surgery (VATS) pulmonary lobectomy became an accepted method for the treatment of early-stage Non-Small-Cell Lung Cancer (NSCLC). There are several variants of VATS lobectomy. In recent years the uniportal approach described by Gonzales-Rivas gained a world-wide interest. The uniportal VATS approach can be performed through the intercostal incision as has been practiced in vast majority of published cases, but there is also another approach, namely the transcervical one, first described by Zakopane team in 2007. In that time, right upper lobectomy and afterwards the left upper lobectomy through the transcervical approach combined with single-port intercostal VATS were performed. The method was to combine lobectomy with Transcervical Extended Mediastinal Lymphadenectomy (TEMLA), preceding a pulmonary resection with intraoperative examination of the mediastinal nodes with the imprint cytology technique. From 2016, after adopting the technique of uniportal intercostal lobectomy, transcervical VATS uniportal lobectomies, without additional intercostal ports were performed. Now, resection of any rightsided or left-sided lobe with the transcervical approach are feasible to be performed.
Surgical Technique Preparation The patient is positioned supine on the operating table with a roll placed beneath the thoracic spine to elevate the chest and to hyperextend the patient's neck. Under general anaesthesia an endobronchial tube is inserted to conduct selective lung ventilation during the latter part of the procedure.
A transverse 6-8 cm transcervical collar incision is made in the neck in a standard way with division and suture-ligation of the anterior jugular veins bilaterally. The sternal manubrium is elevated with sharp one-tooth hook connected to the Zakopane II frame (Aesculap-Chifa, BBraun, Nowy Tomysl, Poland) to widen the access to the mediastinum. The first part of the procedure is TEMLA. The technique of this procedure, and possible pitfalls and the methods of management of intraoperative complications were published elsewhere [6]. In brief, the technique of TEMLA included dissection of all mediastinal nodal stations except for the pulmonary ligaments nodes (station 9). The subcarinal nodes, the periesophageal nodes, the right and left lower paratracheal nodes, and the right hilar nodes (stations 7, 8, 4R, 4L and 10R) were removed in the mediastinoscopy-assisted technique and the paraaortic and the pulmonary-window nodes (stations 6 and 5) are removed in the videothoracoscopy-assisted technique, with the videothoracoscope inserted through the transcervical incision. The superior mediastnal nodes and upper right and left paratracheal nodes (stations 1, 2R and 2L) are removed in the open surgery fashion under direct eye control. The prevascular and retrotracheal nodes (stations 3A and 3P) are removed in pre-selective cases. Generally, the mediastinal pleura is not violated and no drain is left in the mediastinum. Bilateral supraclavicular lymphadenectomy and even deep cervical lymph node dissection is possible during TEMLA through the same incision.
The nodes removed during TEMLA are sent sequentially to intraoperative pathologic examination with use of the imprint cytology technique [4]. The imprint cytology technique is a highly reliable technique much less time consuming than a frozen section analysis. Due to this advantage the time of nodal examinations adds only 15 to 20 minutes to the total time of the operation. After receiving the negative results of the imprint cytology, confirming there are no nodal metastasis the VATS lobectomy part starts. The position of the patient is slightly changed with the introduction of the roll beneath the patient's operating side. Additionally, the operating table is rotated to achieve a semi-lateral position of the patient. The ventillation of the operated lung is disconnected and the mediastinal pleura is opened. Further dissection is performed with the use of endostaplers to manage the lobar vesselts, bronchus and interlobar fissures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| uniportal transcervical approache | Experimental | Procedure: uniportal lobectomy with complete lymphadenectomyUniportal lobectomy with complete lymphadenectomy - transcervical approach with elevation of the sternum |
| uniportal intercostal approache | Experimental | Procedure: uniportal lobectomy with complete lymphadenectomyUniportal lobectomy with complete lymphadenectomy - intercostal approache |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with histologically, or cytologically proven clinical stage I (cI) NSCLC
Key exclusion criteria (3 listed)
- Patients with more advanced NSCLC than clinical stage I (cI) NSCLC
- Severe atherosclerotic lesions of the innominate artery and the aortic arch and previous cardiac surgery.
- Severe pleural adhesions and calcified intrapulmonary nodes after previous tuberculosis are also technical obstacles for this kind of 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 |
|---|---|---|
| uniportal lobectomy with complete lymphadenectomyuniportal lobectomy with complete lymphadenectomy | Procedure or surgery | uniportal intercostal approache, uniportal transcervical approache |
Primary outcome
time of the procedure
Time frame: 4 weeks
duration of the operation in minutes
number of conversions to multi-portal VATS and/or open thoracotomy
Time frame: 4 weeks
number of conversions to multi-portal VATS and/or open thoracotomy
duration of chest drainage
Time frame: 4 weeks
duration of chest drainage in days
volume of chest drainage
Time frame: 4 weeks
volume of chest drainage in ml
amount of postoperatve pain
Time frame: up to 72 hours after the end of surgery
1.pain intensity 0-100 mm VAS scale measured every 4 hours on standard ruler beginning from the end of the surgery. The visual analogue scale (VAS) is commonly used as the outcome measure for such studies. It is usually presented as a 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of "no pain at all" and "worst pain imaginable." Its simplicity, reliability, and validity, as well as its ratio scale properties, make the VAS the optimal tool for describing pain severity or intensity.
time of hospitalization
Time frame: 4 weeks
time of hospitalization in days
number of resected lymph nodes
Time frame: 4 weeks
number of resected lymph nodes
number of resected metastatic nodes
Time frame: 4 weeks
number of resected metastatic nodes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2022.
- Gonzalez D, Paradela M, Garcia J et al. Single-port video-assisted thoracoscopic lobectomy. Interact Cardiovasc Thorac Surg 2011;12:14-5Link provided by the sponsor.
- Zieliński M, Pankowski J, Hauer L et al: The right upper lobe pulmonary resection performed through the transcervical approach. Eur J Cardiothorac Surg. 2007;32:766-769Link provided by the sponsor.
- Zieliński M, Nabialek T, Pankowski J. Transcervical uniportal pulmonary lobectomy. JOVS pulmonary transcervical J Vis Surg. 2018;4:42Link provided by the sponsor.
- 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.
Marcin Zielinski, MD PhD study director
Pulmonary Hospital Zakopane
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing uniportal lobectomy with complete lymphadenectomy in people with Video Assisted Thoracic Surgery (VATS) and Non-Small Cell Lung Cancer (NSCLC), run by Pulmonary Hospital Zakopane at 1 site in Poland.
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 3 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 26 Apr 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 Poland. 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 Marcin Zielinski, MD PhD (0048182015045 ext. 179, marcinz@mp.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time of the procedure (time frame: 4 weeks). The study lists 8 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 26 Apr 2022.