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

NCT03997799 | Unknown DMC

• 1 other identifier: 01/2019
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

lung cancer; mediastinum; pulmonary resection

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (2)

uniportal transcervical approache

EXPERIMENTAL

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

Procedure: uniportal lobectomy with complete lymphadenectomy

uniportal intercostal approache

EXPERIMENTAL

Uniportal lobectomy with complete lymphadenectomy - intercostal approache

Procedure: uniportal lobectomy with complete lymphadenectomy

Interventions

uniportal lobectomy with complete lymphadenectomy PROCEDURE

uniportal lobectomy with complete lymphadenectomy

uniportal intercostal approache; uniportal transcervical approache

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pulmonary Hospital Zakopane: lead

Study Sites (1)

Pulmonary Hospital

Zakopane, 34-500, Poland

RECRUITING

Related 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
• Zieliński M, Nabialek T, Pankowski J. Transcervical uniportal pulmonary lobectomy. JOVS pulmonary transcervical J Vis Surg. 2018;4:42

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Marcin Zielinski, MD PhD

  Pulmonary Hospital Zakopane

  STUDY DIRECTOR

Central Study Contacts

Marcin Zielinski, MD PhD

CONTACT

0048182015045; marcinz@mp.pl

Marcin Zielinski

CONTACT

0048182015045; marcinz@mp.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2019
• First Posted: June 25, 2019
• Study Start: June 10, 2019
• Primary Completion: June 10, 2019
• Study Completion: July 31, 2023
• Last Updated: April 26, 2022

Record last verified: 2022-04

Locations

PL (1)