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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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.

Marcin Zielinski, MD PhD contact

0048182015045 ext. 179

marcinz@mp.pl

Poland1 site, 1 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

    Recruiting

Other trials in Poland

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 groups in NCT03997799
Study groupRoleWhat they receive
uniportal transcervical approacheExperimentalUniportal lobectomy with complete lymphadenectomy - transcervical approach with elevation of the sternum
Receives: Procedure: uniportal lobectomy with complete lymphadenectomy
uniportal intercostal approacheExperimentalUniportal 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.

  1. time of the procedure

    duration of the operation in minutes

    Measured: 4 weeks

  2. 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

  3. duration of chest drainage

    duration of chest drainage in days

    Measured: 4 weeks

  4. volume of chest drainage

    volume of chest drainage in ml

    Measured: 4 weeks

  5. 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

  6. time of hospitalization

    time of hospitalization in days

    Measured: 4 weeks

  7. number of resected lymph nodes

    number of resected lymph nodes

    Measured: 4 weeks

  8. 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.

  1. First posted25 Jun 2019
  2. Study start10 Jun 2019
  3. Primary completion10 Jun 2019
  4. Study completion31 Jul 2023 (estimated)

Resources

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)
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

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.

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