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

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.

Study Overview

• Status: Recruiting
• Conditions: Non-Small Cell Lung Cancer (NSCLC); Video Assisted Thoracic Surgery (VATS)
• Intervention / Treatment: Procedure: uniportal lobectomy with complete lymphadenectomy

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marcin Zielinski, MD PhD; Phone Number: 179 0048182015045; Email: marcinz@mp.pl
• Study Contact Backup: Name: Marcin Zielinski; Phone Number: 0048182015045 0048182015045; Email: marcinz@mp.pl

Study Locations

• Poland
  • Zakopane, Poland, 34-500
    • Recruiting
    • Pulmonary Hospital
    • Contact: Marcin Zielinski, MD Phd; Phone Number: 179 +48182015045; Email: marcinz@mp.pl
    • Contact: Marcin Zielinski, MD Phd; Phone Number: 0048182015045 0048182015045; Email: marcinz@mp.pl
    • Principal Investigator: Michal Wilkojc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: uniportal transcervical approache; Uniportal lobectomy with complete lymphadenectomy - transcervical approach with elevation of the sternum	Procedure: uniportal lobectomy with complete lymphadenectomy; uniportal lobectomy with complete lymphadenectomy
Experimental: uniportal intercostal approache; Uniportal lobectomy with complete lymphadenectomy - intercostal approache	Procedure: uniportal lobectomy with complete lymphadenectomy; uniportal lobectomy with complete lymphadenectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time of the procedure	duration of the operation in minutes	4 weeks
number of conversions to multi-portal VATS and/or open thoracotomy	number of conversions to multi-portal VATS and/or open thoracotomy	4 weeks
duration of chest drainage	duration of chest drainage in days	4 weeks
volume of chest drainage	volume of chest drainage in ml	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.	up to 72 hours after the end of surgery
time of hospitalization	time of hospitalization in days	4 weeks
number of resected lymph nodes	number of resected lymph nodes	4 weeks
number of resected metastatic nodes	number of resected metastatic nodes	4 weeks

Collaborators and Investigators

• Sponsor: Pulmonary Hospital Zakopane
• Investigators: Study Director: Marcin Zielinski, MD PhD, Pulmonary Hospital Zakopane

Publications and helpful links

Helpful Links

• Gonzalez D, Paradela M, Garcia J et al. Single-port video-assisted thoracoscopic lobectomy. Interact Cardiovasc Thorac Surg 2011;12:14-5
• 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
• 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
• Zieliński M, Nabialek T, Pankowski J. Transcervical uniportal pulmonary lobectomy. JOVS pulmonary transcervical J Vis Surg. 2018;4:42
• 6. Zieliński M. Technical pitfalls of transcervical extended mediastinal lymphadenectomy - how to avoid them and to manage intraooperative complications. Semin Thoracic Surg 2010;22:236-243

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2019
• Primary Completion (Actual): June 10, 2019
• Study Completion (Anticipated): July 31, 2023

Study Registration Dates

• First Submitted: June 18, 2019
• First Submitted That Met QC Criteria: June 23, 2019
• First Posted (Actual): June 25, 2019

Study Record Updates

• Last Update Posted (Actual): April 26, 2022
• Last Update Submitted That Met QC Criteria: April 25, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: lung cancer; pulmonary resection; mediastinum
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: 01/2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No