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Comparison of Two Techniques of Uniportal VATS Lobectomies for Clinical Stage I Non-Small Cell Lung Cancer

Primary Purpose

Video Assisted Thoracic Surgery (VATS), Non-Small Cell Lung Cancer (NSCLC)

Status
Recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
uniportal lobectomy with complete lymphadenectomy
Sponsored by
Pulmonary Hospital Zakopane
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Video Assisted Thoracic Surgery (VATS) focused on measuring lung cancer, mediastinum, pulmonary resection

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- Patients with histologically, or cytologically proven clinical stage I (cI) NSCLC

Exclusion Criteria:

  • 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.

Sites / Locations

  • Pulmonary HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

uniportal transcervical approache

uniportal intercostal approache

Arm Description

Uniportal lobectomy with complete lymphadenectomy - transcervical approach with elevation of the sternum

Uniportal lobectomy with complete lymphadenectomy - intercostal approache

Outcomes

Primary Outcome Measures

time of the procedure
duration of the operation in minutes
number of conversions to multi-portal VATS and/or open thoracotomy
number of conversions to multi-portal VATS and/or open thoracotomy
duration of chest drainage
duration of chest drainage in days
volume of chest drainage
volume of chest drainage in ml
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.
time of hospitalization
time of hospitalization in days
number of resected lymph nodes
number of resected lymph nodes
number of resected metastatic nodes
number of resected metastatic nodes

Secondary Outcome Measures

Full Information

First Posted
June 18, 2019
Last Updated
April 25, 2022
Sponsor
Pulmonary Hospital Zakopane
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1. Study Identification

Unique Protocol Identification Number
NCT03997799
Brief Title
Comparison of Two Techniques of Uniportal VATS Lobectomies for Clinical Stage I Non-Small Cell Lung Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 10, 2019 (Actual)
Primary Completion Date
June 10, 2019 (Actual)
Study Completion Date
July 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pulmonary Hospital Zakopane

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Video Assisted Thoracic Surgery (VATS), Non-Small Cell Lung Cancer (NSCLC)
Keywords
lung cancer, mediastinum, pulmonary resection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
uniportal transcervical approache
Arm Type
Experimental
Arm Description
Uniportal lobectomy with complete lymphadenectomy - transcervical approach with elevation of the sternum
Arm Title
uniportal intercostal approache
Arm Type
Experimental
Arm Description
Uniportal lobectomy with complete lymphadenectomy - intercostal approache
Intervention Type
Procedure
Intervention Name(s)
uniportal lobectomy with complete lymphadenectomy
Intervention Description
uniportal lobectomy with complete lymphadenectomy
Primary Outcome Measure Information:
Title
time of the procedure
Description
duration of the operation in minutes
Time Frame
4 weeks
Title
number of conversions to multi-portal VATS and/or open thoracotomy
Description
number of conversions to multi-portal VATS and/or open thoracotomy
Time Frame
4 weeks
Title
duration of chest drainage
Description
duration of chest drainage in days
Time Frame
4 weeks
Title
volume of chest drainage
Description
volume of chest drainage in ml
Time Frame
4 weeks
Title
amount of postoperatve pain
Description
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 Frame
up to 72 hours after the end of surgery
Title
time of hospitalization
Description
time of hospitalization in days
Time Frame
4 weeks
Title
number of resected lymph nodes
Description
number of resected lymph nodes
Time Frame
4 weeks
Title
number of resected metastatic nodes
Description
number of resected metastatic nodes
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - Patients with histologically, or cytologically proven clinical stage I (cI) NSCLC Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marcin Zielinski, MD PhD
Phone
0048182015045
Ext
179
Email
marcinz@mp.pl
First Name & Middle Initial & Last Name or Official Title & Degree
Marcin Zielinski
Phone
0048182015045
Ext
0048182015045
Email
marcinz@mp.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcin Zielinski, MD PhD
Organizational Affiliation
Pulmonary Hospital Zakopane
Official's Role
Study Director
Facility Information:
Facility Name
Pulmonary Hospital
City
Zakopane
ZIP/Postal Code
34-500
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcin Zielinski, MD Phd
Phone
+48182015045
Ext
179
Email
marcinz@mp.pl
First Name & Middle Initial & Last Name & Degree
Marcin Zielinski, MD Phd
Phone
0048182015045
Ext
0048182015045
Email
marcinz@mp.pl
First Name & Middle Initial & Last Name & Degree
Michal Wilkojc

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Links:
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3771611/
Description
Gonzalez D, Paradela M, Garcia J et al. Single-port video-assisted thoracoscopic lobectomy. Interact Cardiovasc Thorac Surg 2011;12:14-5
URL
https://www.ncbi.nlm.nih.gov/pubmed/17766130
Description
Zieliński M, Pankowski J, Hauer L et al: The right upper lobe pulmonary resection performed through the transcervical approach. Eur J Cardiothorac Surg. 2007;32:766-769
URL
https://academic.oup.com/ejcts/article/43/2/297/466654
Description
Jakubiak M, Pankowski J, Obrochta A et al. Fast cytological evaluation of lymphatic nodes obtained during transcervical extended mediastinal lymphadenectomy† European Journal of Cardio-Thoracic Surgery 43 (2013) 297-301
URL
http://jovs.amegroups.com/article/view/18531/18723
Description
Zieliński M, Nabialek T, Pankowski J. Transcervical uniportal pulmonary lobectomy. JOVS pulmonary transcervical J Vis Surg. 2018;4:42

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Comparison of Two Techniques of Uniportal VATS Lobectomies for Clinical Stage I Non-Small Cell Lung Cancer

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