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Retrospective Multi-Center Study to Compare Perioperative Outcomes for Robotic-assisted Lobectomy With Those Associated With VATS and Open Lobectomy for Lung Cancer

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ClinicalTrials.gov Identifier: NCT03347825
Recruitment Status : Active, not recruiting
First Posted : November 20, 2017
Last Update Posted : March 5, 2018
Sponsor:
Information provided by (Responsible Party):
Intuitive Surgical

Brief Summary:
The main objective of this study is to compare perioperative outcomes for robotic-assisted lobectomy with those associated with VATS and open lobectomy for lung cancer

Condition or disease Intervention/treatment
Lung Cancer Procedure: Robotic-assisted lobectomy using da Vinci Surgical System Procedure: VATS (video assisted thoracic surgery) Procedure: Open lobectomy

Detailed Description:

This is a multi-center, retrospective chart review study of all consecutive lobectomies performed for clinical stage IA, IB, IIA, IIB and IIIA lung cancer, performed by participating surgeons at their respective institutions that meet all inclusion and exclusion criteria. All cases of lobectomy performed for clinical stages, IA, IB, IIA, IIB and IIIA lung cancer via robotic-assisted, VATS (video assisted thoracic surgery) and open approach that meet the study inclusion and exclusion criteria will be considered for inclusion in the study. The chart review and data collection will be performed in a reverse chronological order starting at 30 days prior to IRB approval of the study at the institution and going back to 2013 (i.e most current data in 2017 and chronologically going back through 2013). The retrospective chart review and data collection is anticipated to occur in two phases:

Phase-I: Phase I will include chart review and data collection of clinical stage IB, IIA, IIB, IIIA cases from approximately 30-days prior to IRB approval of the study in 2017 or early 2018 and will continue retrospectively thru January 1, 2013 at each institution.

Phase-II: This phase will be initiated after completion of phase-I at each institution and will include chart review and data collection of clinical stage IA cases from approximately 30-days prior to IRB approval of the study in 2017 or early 2018 and will continue retrospectively thru January 1, 2013 at each institution.

Depending on availability of research coordinator resource (s) at each institution, the institution can choose to complete the data collection of both the phases either simultaneously or sequentially.

Baseline patient characteristics, perioperative and post-operative short term clinical and pathological outcomes data will be obtained from hospital records. Each participating institution will contribute approximately 100-800 cases from one or more surgeons. Since the data will have been de-identified, and is archival in nature, there will be no active subject recruitment and no patient consenting is required


Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Retrospective Multi-Center Study for Evaluation of Clinical Outcomes With Lobectomy for Lung Cancer
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : May 1, 2019
Estimated Study Completion Date : May 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Group/Cohort Intervention/treatment
Robotic-assisted lobectomy
Pre-operative, intra-operative and post-operative clinical, surgical and oncological information will be obtained from institutional records for patients who underwent robotic-assisted lobectomy for lung cancer.
Procedure: Robotic-assisted lobectomy using da Vinci Surgical System
Robotic-assisted lobectomy

VATS (video assisted thoracic surgery) lobectomy
Pre-operative, intra-operative and post-operative clinical, surgical and oncological information will be obtained from institutional records for patients who underwent VATS lobectomy for lung cancer.
Procedure: VATS (video assisted thoracic surgery)
VATS (video assisted thoracic surgery)

Open lobectomy
Pre-operative, intra-operative and post-operative clinical, surgical and oncological information will be obtained from institutional records for patients who underwent open lobectomy for lung cancer.
Procedure: Open lobectomy
Open lobectomy




Primary Outcome Measures :
  1. Chart review and data collection of clinical stage IB, IIA, IIB, IIIA cases [ Time Frame: 2013-2018 ]
    Data collection of clinical stage IB, IIA, IIB, IIIA cases


Secondary Outcome Measures :
  1. Chart review and data collection of clinical Stage IA [ Time Frame: 2013-2018 ]
    Data collection of clinical Stage IA



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients who underwent robotic-assisted, VATS or open lobectomy for lung cancer.
Criteria

Inclusion Criteria:

  • Subject is 18 years or older
  • Subject who has undergone elective robotic-assisted, VATS or open lobectomy for clinically diagnosed primary stage IA, IB, IIA, IIB and IIIA lung cancer, with or without neo-adjuvant therapy

Exclusion Criteria:

  • Subject with stage IIIB lung cancer
  • Subject who received lobectomy as an emergent procedure
  • Subjects who received lobectomy for metastatic cancer

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03347825


Locations
United States, Texas
BaylorScott&White
Dallas, Texas, United States, 75093
Sponsors and Collaborators
Intuitive Surgical

Responsible Party: Intuitive Surgical
ClinicalTrials.gov Identifier: NCT03347825     History of Changes
Other Study ID Numbers: ISI-dVLob-001
First Posted: November 20, 2017    Key Record Dates
Last Update Posted: March 5, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases