Lung Cancer Clinical Trial
— PATCHESOfficial title:
Prospective Randomized Study on the Efficacy of Three-dimensional Reconstructions of Bronchial and Vascular Structures on Preoperative Chest CT Scan in Patients Who Are Candidates for Pulmonary Segmentectomy Surgery
With this project we want to study the effectiveness of 3D reconstruction of preoperative CT to reduce operating times, blood loss and conversions after segmentectomy performed in thoracoscopy / robotics.
Status | Not yet recruiting |
Enrollment | 288 |
Est. completion date | May 1, 2026 |
Est. primary completion date | March 1, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Segmentectomy performed through a minimally invasive approach (VATS or RATS). - Pathologically proven NSCLC on the resected specimen. - Age =18 - Signed written informed consent Exclusion Criteria: - Prior homolateral cardiothoracic surgery. - Allergy or any other contraindication to iodinated contrast media. - Segmentectomy performed through an open approach (thoracotomy) - Histology different than NSCLC. - Pregnancy |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Ospedale Centrale Bolzano | Chinese University of Hong Kong, Ernst von Bergmann Hospital, European Institute of Oncology, Harvard University, Philipps University Marburg Medical Center, University of Belgrade, University of Salamanca, Wolfson Medical Center |
Akiba T, Marushima H, Harada J, Kobayashi S, Morikawa T. Importance of preoperative imaging with 64-row three-dimensional multidetector computed tomography for safer video-assisted thoracic surgery in lung cancer. Surg Today. 2009;39(10):844-7. doi: 10.1007/s00595-009-3965-1. Epub 2009 Sep 27. — View Citation
Akiba T. Utility of three-dimensional computed tomography in general thoracic surgery. Gen Thorac Cardiovasc Surg. 2013 Dec;61(12):676-84. doi: 10.1007/s11748-013-0336-z. Epub 2013 Oct 25. — View Citation
Allemani C, Matsuda T, Di Carlo V, Harewood R, Matz M, Niksic M, Bonaventure A, Valkov M, Johnson CJ, Esteve J, Ogunbiyi OJ, Azevedo E Silva G, Chen WQ, Eser S, Engholm G, Stiller CA, Monnereau A, Woods RR, Visser O, Lim GH, Aitken J, Weir HK, Coleman MP; CONCORD Working Group. Global surveillance of trends in cancer survival 2000-14 (CONCORD-3): analysis of individual records for 37 513 025 patients diagnosed with one of 18 cancers from 322 population-based registries in 71 countries. Lancet. 2018 Mar 17;391(10125):1023-1075. doi: 10.1016/S0140-6736(17)33326-3. Epub 2018 Jan 31. — View Citation
Bao F, Ye P, Yang Y, Wang L, Zhang C, Lv X, Hu J. Segmentectomy or lobectomy for early stage lung cancer: a meta-analysis. Eur J Cardiothorac Surg. 2014 Jul;46(1):1-7. doi: 10.1093/ejcts/ezt554. Epub 2013 Dec 8. — 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
Hung MH, Cheng YJ, Chan KC, Han SC, Chen KC, Hsu HH, Chen JS. Nonintubated uniportal thoracoscopic surgery for peripheral lung nodules. Ann Thorac Surg. 2014 Dec;98(6):1998-2003. doi: 10.1016/j.athoracsur.2014.07.036. Epub 2014 Oct 28. — View Citation
Liu X, Zhao Y, Xuan Y, Lan X, Zhao J, Lan X, Han B, Jiao W. Three-dimensional printing in the preoperative planning of thoracoscopic pulmonary segmentectomy. Transl Lung Cancer Res. 2019 Dec;8(6):929-937. doi: 10.21037/tlcr.2019.11.27. — View Citation
Nomori H, Mori T, Shiraishi A, Fujino K, Sato Y, Ito T, Suzuki M. Long-Term Prognosis After Segmentectomy for cT1 N0 M0 Non-Small Cell Lung Cancer. Ann Thorac Surg. 2019 May;107(5):1500-1506. doi: 10.1016/j.athoracsur.2018.11.046. Epub 2018 Dec 21. — View Citation
Oizumi H, Kanauchi N, Kato H, Endoh M, Suzuki J, Fukaya K, Sadahiro M. Anatomic thoracoscopic pulmonary segmentectomy under 3-dimensional multidetector computed tomography simulation: a report of 52 consecutive cases. J Thorac Cardiovasc Surg. 2011 Mar;141(3):678-82. doi: 10.1016/j.jtcvs.2010.08.027. Epub 2010 Sep 29. — View Citation
Qiu B, Ji Y, He H, Zhao J, Xue Q, Gao S. Three-dimensional reconstruction/personalized three-dimensional printed model for thoracoscopic anatomical partial-lobectomy in stage I lung cancer: a retrospective study. Transl Lung Cancer Res. 2020 Aug;9(4):1235-1246. doi: 10.21037/tlcr-20-571. — View Citation
She XW, Gu YB, Xu C, Li C, Ding C, Chen J, Zhao J. Three-dimensional (3D)- computed tomography bronchography and angiography combined with 3D-video-assisted thoracic surgery (VATS) versus conventional 2D-VATS anatomic pulmonary segmentectomy for the treatment of non-small cell lung cancer. Thorac Cancer. 2018 Feb;9(2):305-309. doi: 10.1111/1759-7714.12585. Epub 2018 Jan 3. — View Citation
Shimizu K, Nagashima T, Ohtaki Y, Obayashi K, Nakazawa S, Kamiyoshihara M, Igai H, Takeyoshi I, Mogi A, Kuwano H. Analysis of the variation pattern in right upper pulmonary veins and establishment of simplified vein models for anatomical segmentectomy. Gen Thorac Cardiovasc Surg. 2016 Oct;64(10):604-11. doi: 10.1007/s11748-016-0686-4. Epub 2016 Jul 19. — View Citation
Stiles BM, Mao J, Harrison S, Lee B, Port JL, Altorki NK, Sedrakyan A. Sublobar resection for node-negative lung cancer 2-5 cm in size. Eur J Cardiothorac Surg. 2019 Nov 1;56(5):858-866. doi: 10.1093/ejcts/ezz146. — View Citation
Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4. — View Citation
Suzuki K, Saji H, Aokage K, Watanabe SI, Okada M, Mizusawa J, Nakajima R, Tsuboi M, Nakamura S, Nakamura K, Mitsudomi T, Asamura H; West Japan Oncology Group; Japan Clinical Oncology Group. Comparison of pulmonary segmentectomy and lobectomy: Safety results of a randomized trial. J Thorac Cardiovasc Surg. 2019 Sep;158(3):895-907. doi: 10.1016/j.jtcvs.2019.03.090. Epub 2019 Apr 9. — View Citation
Wu H, Jin R, Yang S, Park BJ, Li H. Long-term and short-term outcomes of robot- versus video-assisted anatomic lung resection in lung cancer: a systematic review and meta-analysis. Eur J Cardiothorac Surg. 2021 Apr 29;59(4):732-740. doi: 10.1093/ejcts/ezaa426. — View Citation
Wu Z, Huang Z, Qin Y, Jiao W. Progress in three-dimensional computed tomography reconstruction in anatomic pulmonary segmentectomy. Thorac Cancer. 2022 Jul;13(13):1881-1887. doi: 10.1111/1759-7714.14443. Epub 2022 May 18. — View Citation
Xue L, Fan H, Shi W, Ge D, Zhang Y, Wang Q, Yuan Y. Preoperative 3-dimensional computed tomography lung simulation before video-assisted thoracoscopic anatomic segmentectomy for ground glass opacity in lung. J Thorac Dis. 2018 Dec;10(12):6598-6605. doi: 10.21037/jtd.2018.10.126. — View Citation
Zhao ZR, Situ DR, Lau RWH, Mok TSK, Chen GG, Underwood MJ, Ng CSH. Comparison of Segmentectomy and Lobectomy in Stage IA Adenocarcinomas. J Thorac Oncol. 2017 May;12(5):890-896. doi: 10.1016/j.jtho.2017.01.012. Epub 2017 Jan 20. — View Citation
* Note: There are 19 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Conversions from minimally invasive to thoracotomic procedure | Evaluation of conversions from minimally invasive to thoracotomic procedure | Intraoperative | |
Primary | Margin- and disease-free resection | Margin- and disease-free resection | 1 Month postoperative | |
Secondary | Operating times | Evaluation of operating times | Intraoperative | |
Secondary | Intraoperative blood loss | Evaluation of intraoperative blood loss | Intraoperative | |
Secondary | Intraoperative major bleeding | Intraoperative major bleeding | Intraoperative | |
Secondary | Intraoperative air leaks and the use of sealants | Evaluation of intraoperative air leaks and the use of sealants | Intraoperative | |
Secondary | Postoperative air leaks | Evaluation of postoperative air leaks | up to 2 weeks | |
Secondary | Hospitalization times | Evaluation of hospitalization times | up to 3 weeks |
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