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Prospective rAndomized sTudy efficaCy tHree-dimensional rEconstructions Segmentectomy

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05716815
Acronym
PATCHES
Enrollment
288
Registered
2023-02-08
Start date
2023-10-01
Completion date
2026-05-01
Last updated
2023-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer, Lung; Node

Keywords

Lung Segmentectomy, CT 3D Recostruction, VATS, RATS

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.

Detailed 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.

Interventions

DIAGNOSTIC_TESTCT 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.

DIAGNOSTIC_TESTCT 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.

Sponsors

European Institute of Oncology
CollaboratorOTHER
Philipps University Marburg
CollaboratorOTHER
Ernst von Bergmann Hospital
CollaboratorOTHER
Chinese University of Hong Kong
CollaboratorOTHER
Wolfson Medical Center
CollaboratorOTHER_GOV
University of Belgrade
CollaboratorOTHER
Harvard University
CollaboratorOTHER
University of Salamanca
CollaboratorOTHER
Ospedale Centrale Bolzano
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

A prospective multicenter randomized study

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Conversions from minimally invasive to thoracotomic procedureIntraoperativeEvaluation of conversions from minimally invasive to thoracotomic procedure
Margin- and disease-free resection1 Month postoperativeMargin- and disease-free resection

Secondary

MeasureTime frameDescription
Intraoperative major bleedingIntraoperativeIntraoperative major bleeding
Intraoperative air leaks and the use of sealantsIntraoperativeEvaluation of intraoperative air leaks and the use of sealants
Operating timesIntraoperativeEvaluation of operating times
Hospitalization timesup to 3 weeksEvaluation of hospitalization times
Postoperative air leaksup to 2 weeksEvaluation of postoperative air leaks
Intraoperative blood lossIntraoperativeEvaluation of intraoperative blood loss

Contacts

Primary ContactZARACA Zaraca
francesco.zaraca@sabes.it+393334854703
Backup ContactMarco Damiano Pipitone
marcodamianopipitone@gmail.com+393281568398

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026