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PATCHES: Prospective rAndomized sTudy efficaCy tHree-dimensional rEconstructions Segmentectomy

Sponsor
Ospedale Centrale Bolzano (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05716815
Collaborator
European Institute of Oncology (Other), Philipps University Marburg Medical Center (Other), Ernst von Bergmann Hospital (Other), Chinese University of Hong Kong (Other), Wolfson Medical Center (Other), University of Belgrade (Other), Harvard University (Other), University of Salamanca (Other)
288
Enrollment
2
Arms
38
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: CT scans 2D Reconstruction
  • Diagnostic Test: CT scans 2D plus 3D Reconstruction
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
288 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
A prospective multicenter randomized studyA prospective multicenter randomized study
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Mar 1, 2026
Anticipated Study Completion Date :
May 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 2D Reconstruction

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
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.
Experimental: 2D plus 3D Reconstruction

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
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.

Outcome Measures

Primary Outcome Measures

  1. Conversions from minimally invasive to thoracotomic procedure [Intraoperative]

    Evaluation of conversions from minimally invasive to thoracotomic procedure

  2. Margin- and disease-free resection [1 Month postoperative]

    Margin- and disease-free resection

Secondary Outcome Measures

  1. Operating times [Intraoperative]

    Evaluation of operating times

  2. Intraoperative blood loss [Intraoperative]

    Evaluation of intraoperative blood loss

  3. Intraoperative major bleeding [Intraoperative]

    Intraoperative major bleeding

  4. Intraoperative air leaks and the use of sealants [Intraoperative]

    Evaluation of intraoperative air leaks and the use of sealants

  5. Postoperative air leaks [up to 2 weeks]

    Evaluation of postoperative air leaks

  6. Hospitalization times [up to 3 weeks]

    Evaluation of hospitalization times

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: ZARACA FRANCESCO, Central Hospital Bolzano

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Francesco Zaraca, MD PhD Privat Dozent, Ospedale Centrale Bolzano
ClinicalTrials.gov Identifier:
NCT05716815
Other Study ID Numbers:
  • 1-2023
First Posted:
Feb 8, 2023
Last Update Posted:
Feb 8, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Francesco Zaraca, MD PhD Privat Dozent, Ospedale Centrale Bolzano
Lung Segmentectomy
CT 3D Recostruction
VATS
RATS

Study Results

No Results Posted as of Feb 8, 2023