Prospective rAndomized sTudy efficaCy tHree-dimensional rEconstructions Segmentectomy

NCT05716815 | Not Yet Recruiting

• 1 other identifier: 1-2023
• Study Type: interventional
• Target: 288
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Lung Cancer; Lung; Node

Keywords

Lung Segmentectomy; CT 3D Recostruction; VATS; RATS

Outcome Measures

Primary Outcomes (2)

• Conversions from minimally invasive to thoracotomic procedure

  Evaluation of conversions from minimally invasive to thoracotomic procedure

  Intraoperative

• Margin- and disease-free resection

  Margin- and disease-free resection

  1 Month postoperative

Secondary Outcomes (6)

• Operating times

  Intraoperative

• Intraoperative blood loss

  Intraoperative

• Intraoperative major bleeding

  Intraoperative

• Intraoperative air leaks and the use of sealants

  Intraoperative

• Postoperative air leaks

  up to 2 weeks

Study Arms (2)

2D Reconstruction

ACTIVE COMPARATOR

Before minimally invasive lung segmentectomy, preoperative chest CT scans are processed and evaluated with multi-plane (2D) reconstructions, according to the usual center protocol.

Diagnostic Test: CT scans 2D Reconstruction

2D plus 3D Reconstruction

EXPERIMENTAL

Before minimally invasive lung segmentectomy, preoperative chest CT scans are processed and evaluated with volume rendering (3D) reconstructions.

Diagnostic Test: CT scans 2D plus 3D Reconstruction

Interventions

CT scans 2D Reconstruction DIAGNOSTIC_TEST

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.

2D Reconstruction

CT scans 2D plus 3D Reconstruction DIAGNOSTIC_TEST

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.

2D plus 3D Reconstruction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Segmentectomy performed through a minimally invasive approach (VATS or RATS).
• Pathologically proven NSCLC on the resected specimen.
• Age ≥18
• Signed written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Ospedale Centrale Bolzano: lead
• European Institute of Oncology: collaborator
• Philipps University Marburg: collaborator
• Ernst von Bergmann Hospital: collaborator
• Chinese University of Hong Kong: collaborator
• Wolfson Medical Center: collaborator
• University of Belgrade: collaborator
• Harvard University: collaborator
• University of Salamanca: collaborator

Related Publications (20)

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• 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.

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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.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

  PMID: 20884021 BACKGROUND

• Zaraca F, Kirschbaum A, Pipitone MD, Bertolaccini L; PATCHES study group. Prospective randomized study on the efficacy of three-dimensional reconstructions of bronchovascular structures on preoperative chest CT scan in patients who are candidates for pulmonary segmentectomy surgery: the PATCHES (Prospective rAndomized sTudy efficaCy of tHree-dimensional rEconstructions Segmentecomy) study protocol. Trials. 2023 Sep 16;24(1):594. doi: 10.1186/s13063-023-07600-w.

  PMID: 37717001 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• ZARACA FRANCESCO

  Central Hospital Bolzano

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ZARACA Zaraca

CONTACT

+393334854703; francesco.zaraca@sabes.it

Marco Damiano Pipitone

CONTACT

+393281568398; marcodamianopipitone@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD Privat Dozent

Model Details: A prospective multicenter randomized study

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: February 8, 2023
• Study Start: October 1, 2023
• Primary Completion: March 1, 2026
• Study Completion: May 1, 2026
• Last Updated: August 29, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share