Prospective rAndomized sTudy efficaCy tHree-dimensional rEconstructions Segmentectomy

Lung Cancer Clinical Trial

— PATCHES  

Official 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05716815
• Other study ID #: 1-2023
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Lung Cancer
• Lung; Node

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)

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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

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