Videothoracoscopic (VATS) vs. Robotic Approach for Lobectomy or Anatomical Segmentectomy

Lung Cancer Clinical Trial

— ROMAN  

Official title:

Prospective, Randomized, Multicentric Study On Videothoracoscopic (Vats) Vs Robotic Approach For Lobectomy Or Anatomical Segmentectomy In Patients Affected By Early Lung Cancer (ROMAN)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02804893
• Other study ID #: 1566
• Status: Recruiting
• Phase: N/A
• Start date: March 6, 2017
• Est. completion date: March 6, 2023

Study information

• Verified date: December 2018
• Source: Istituto Clinico Humanitas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospective, randomized, multicenter study on 300 patients (150 VATS lobectomies and 150 robotic lobectomies) affected by early stage (I-II) lung cancer. The expected recruitment is one year and two year follow up. Surgeons should have a minimum of 30 major lung resections performed using one of the two techniques for participation in the study. Each participating centers should have the possibility to offer both techniques (Robotics and Vats). The primary end point is a combination of conversion and complication rate. The presence of at least one of the two events is considered a failure. Considering the rate of failure of 35% in the VATS arm, we want to see a failure rate not over 20% in the robot arm, so with a power of 80% and an alpha error of 5%, we need a total of 300 patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: March 6, 2023
• Est. primary completion date: March 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age older than 18 years old

• Known or suspected lung cancers

• Patients in clinical stage T1-T2, N0-N1 candidate to surgery lobectomy or anatomical segmentectomy

• ASA-1-2-3

Exclusion Criteria:

• Clinical stage >II

• Severe heart disease

• Alcohol abuse

• Renal impairment (creatinine >2.5)

• Presence of serious comorbidities

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Procedure:
• VATS
Thorax thoracoscopic surgery (lobectomy)
• RATS
Thorax robotic surgery (lobectomy)

Locations

Country	Name	City	State
Italy	Thoracic surgery Division, Istituto Clinico Humanitas	Rozzano	Milan

Sponsors (2)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas	Fondazione Umberto Veronesi

Country where clinical trial is conducted

Italy, 

References & Publications (17)

Cao C, Tian DH, Wolak K, Oparka J, He J, Dunning J, Walker WS, Yan TD. Cross-sectional survey on lobectomy approach (X-SOLA). Chest. 2014 Aug;146(2):292-298. doi: 10.1378/chest.13-1075. — View Citation

Daniels LJ, Balderson SS, Onaitis MW, D'Amico TA. Thoracoscopic lobectomy: a safe and effective strategy for patients with stage I lung cancer. Ann Thorac Surg. 2002 Sep;74(3):860-4. — View Citation

Demmy TL, Curtis JJ. Minimally invasive lobectomy directed toward frail and high-risk patients: a case-control study. Ann Thorac Surg. 1999 Jul;68(1):194-200. — View Citation

Gharagozloo F, Margolis M, Tempesta B, Strother E, Najam F. Robot-assisted lobectomy for early-stage lung cancer: report of 100 consecutive cases. Ann Thorac Surg. 2009 Aug;88(2):380-4. doi: 10.1016/j.athoracsur.2009.04.039. — View Citation

Hoksch B, Ablassmaier B, Walter M, Müller JM. [Complication rate after thoracoscopic and conventional lobectomy]. Zentralbl Chir. 2003 Feb;128(2):106-10. German. — View Citation

Leschber G, Holinka G, Linder A. Video-assisted mediastinoscopic lymphadenectomy (VAMLA)--a method for systematic mediastinal lymphnode dissection. Eur J Cardiothorac Surg. 2003 Aug;24(2):192-5. — View Citation

Li WW, Lee RL, Lee TW, Ng CS, Sihoe AD, Wan IY, Arifi AA, Yim AP. The impact of thoracic surgical access on early shoulder function: video-assisted thoracic surgery versus posterolateral thoracotomy. Eur J Cardiothorac Surg. 2003 Mar;23(3):390-6. — View Citation

Louie BE, Farivar AS, Aye RW, Vallières E. Early experience with robotic lung resection results in similar operative outcomes and morbidity when compared with matched video-assisted thoracoscopic surgery cases. Ann Thorac Surg. 2012 May;93(5):1598-604; di — View Citation

McKenna RJ Jr, Wolf RK, Brenner M, Fischel RJ, Wurnig P. Is lobectomy by video-assisted thoracic surgery an adequate cancer operation? Ann Thorac Surg. 1998 Dec;66(6):1903-8. — View Citation

Melfi FM, Menconi GF, Mariani AM, Angeletti CA. Early experience with robotic technology for thoracoscopic surgery. Eur J Cardiothorac Surg. 2002 May;21(5):864-8. — View Citation

Nakamura H. Systematic review of published studies on safety and efficacy of thoracoscopic and robot-assisted lobectomy for lung cancer. Ann Thorac Cardiovasc Surg. 2014;20(2):93-8. Epub 2014 Feb 28. Review. — View Citation

Nakata M, Saeki H, Yokoyama N, Kurita A, Takiyama W, Takashima S. Pulmonary function after lobectomy: video-assisted thoracic surgery versus thoracotomy. Ann Thorac Surg. 2000 Sep;70(3):938-41. — View Citation

Nomori H, Ohtsuka T, Horio H, Naruke T, Suemasu K. Difference in the impairment of vital capacity and 6-minute walking after a lobectomy performed by thoracoscopic surgery, an anterior limited thoracotomy, an anteroaxillary thoracotomy, and a posterolater — View Citation

Park BJ, Flores RM, Rusch VW. Robotic assistance for video-assisted thoracic surgical lobectomy: technique and initial results. J Thorac Cardiovasc Surg. 2006 Jan;131(1):54-9. — View Citation

Veronesi G, Galetta D, Maisonneuve P, Melfi F, Schmid RA, Borri A, Vannucci F, Spaggiari L. Four-arm robotic lobectomy for the treatment of early-stage lung cancer. J Thorac Cardiovasc Surg. 2010 Jul;140(1):19-25. doi: 10.1016/j.jtcvs.2009.10.025. Epub 20 — View Citation

Yim AP, Landreneau RJ, Izzat MB, Fung AL, Wan S. Is video-assisted thoracoscopic lobectomy a unified approach? Ann Thorac Surg. 1998 Oct;66(4):1155-8. — View Citation

Yim AP, Wan S, Lee TW, Arifi AA. VATS lobectomy reduces cytokine responses compared with conventional surgery. Ann Thorac Surg. 2000 Jul;70(1):243-7. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraoperative complications: conversion rate, defined as procedures that start with minimally invasive access and are converted to open surgery due to different reasons (bleeding, anatomical reasons, oncological reasons, technical reasons, other)		date of Surgery
Primary	Postoperative complications: surgical complications, higher or equal grade II assessed by Clavien-Dindo scale, within 90 days		within 90 days
Secondary	Duration of surgery		date of Surgery
Secondary	Number of resected lymph nodes and upstaging		date of Surgery
Secondary	Proportion of patients who undergo complete resection during the procedure		date of Surgery
Secondary	Postoperative hospital stay		2 weeks
Secondary	Postoperative pain: daily evaluation with visual numeric scale before and after surgery until discharge		2 weeks, 6 months and 12 months
Secondary	Quality of life by EORTC QOL-C30		2 weeks, 6 months and 12 months
Secondary	Duration of analgesic use after discharge and time to return to normal daily activity		within 90 days
Secondary	Postoperative respiratory function: FEV 1, PEF and CV		6 month postoperatively
Secondary	Rate of local and distant recurrence and disease free survival		24 months
Secondary	Patient's immune response: analysis of PCR, serum interleukins, lymphocytes subpopulations		before surgery, 2 hours after surgery and at 3rd and 14th postoperative day