Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03997799
Recruitment Status : Recruiting
First Posted : June 25, 2019
Last Update Posted : June 28, 2019
Sponsor:
Information provided by (Responsible Party):
Pulmonary Hospital Zakopane

Tracking Information
First Submitted Date  ICMJE June 18, 2019
First Posted Date  ICMJE June 25, 2019
Last Update Posted Date June 28, 2019
Actual Study Start Date  ICMJE June 10, 2019
Actual Primary Completion Date June 10, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 26, 2019)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: June 23, 2019)
  • 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: 4 weeks ]
    Diagnostic Test: pain intensity measured in VAS scale
  • 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
Change History Complete list of historical versions of study NCT03997799 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Two Techniques of Uniportal VATS Lobectomies for Clinical Stage I Non-Small Cell Lung Cancer
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Video Assisted Thoracic Surgery (VATS)
  • Non-Small Cell Lung Cancer (NSCLC)
Intervention  ICMJE Procedure: uniportal lobectomy with complete lymphadenectomy
uniportal lobectomy with complete lymphadenectomy
Study Arms  ICMJE
  • Experimental: uniportal transcervical approache
    Uniportal lobectomy with complete lymphadenectomy - transcervical approach with elevation of the sternum
    Intervention: Procedure: uniportal lobectomy with complete lymphadenectomy
  • Experimental: uniportal intercostal approache
    Uniportal lobectomy with complete lymphadenectomy - intercostal approache
    Intervention: Procedure: uniportal lobectomy with complete lymphadenectomy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 23, 2019)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 1, 2020
Actual Primary Completion Date June 10, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Marcin Zielinski, MD PhD 0048182015045 ext 179 marcinz@mp.pl
Contact: Marcin Zielinski 0048182015045 ext 0048182015045 marcinz@mp.pl
Listed Location Countries  ICMJE Poland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03997799
Other Study ID Numbers  ICMJE 01/2019
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Pulmonary Hospital Zakopane
Study Sponsor  ICMJE Pulmonary Hospital Zakopane
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Marcin Zielinski, MD PhD Pulmonary Hospital Zakopane
PRS Account Pulmonary Hospital Zakopane
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP