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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05716815
Other study ID # 1-2023
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 1, 2023
Est. completion date May 1, 2026

Study information

Verified date August 2023
Source Ospedale Centrale Bolzano
Contact ZARACA Zaraca
Phone +393334854703
Email francesco.zaraca@sabes.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

Pulmonary segmentectomy is the surgery of first choice in malignant lung tumors with a diameter <2 cm in diameter. Patients who are candidates for this type of treatment perform usually a preoperative CT scan with two-dimensional reconstructions (2D: axial, coronary and sagittal). Today it is possible to perform a preoperative three-dimensional reconstruction (3D: volume rendering) of the vessels and bronchi using special software. Objectives of the study is to analyze, in these patients, the benefits of 3D reconstruction of vessels and bronchi compared to 2D reconstruction, analyzing intra- and post-operative data.The study aims to randomize 288 patients over 36 months. Study design: Prospective, randomized, controlled study. In 50% of patients the preoperative study of anatomical structures will be performed with the standard 2D method, in the remaining 50% with a 2D and 3D reconstruction. The assignment will take place through access to an online feature on the study website. Evaluations and statistical methods The statistical analysis will be carried out using parametric and nonparametric descriptive, inferential statistical methods, while the main outcome will be carried out using the analysis of variance (ANOVA) and covariance (ANCOVA) techniques. Ethical aspects. The study will be conducted in accordance with applicable current legislation. Approval by all relevant ethics committees will be required. Each patient will provide a written consent to participate in the study, after being properly informed.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
CT scans 2D Reconstruction
Before performing the surgery, patient performs a chest CT scan with contrast medium and standard two-dimensional (2D) reconstructions are performed to study the lesion, the anatomy of the bronchi and the pulmonary venous and arterial vessels.
CT scans 2D plus 3D Reconstruction
Before performing the surgery, patient performs a chest CT scan with contrast medium and standard two-dimensional (2D) reconstructions plus a 3D reconstruction are performed to study the lesion, the anatomy of the bronchi and the pulmonary venous and arterial vessels.

Locations

Country Name City State
n/a

Sponsors (9)

Lead Sponsor Collaborator
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

References & Publications (19)

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 allClick here to view all references

Outcome

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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