Prospective rAndomized sTudy efficaCy tHree-dimensional rEconstructions Segmentectomy (PATCHES)

August 26, 2023 updated by: Francesco Zaraca, Ospedale Centrale Bolzano

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

288

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Conversions from minimally invasive to thoracotomic procedure
Time Frame: Intraoperative
Evaluation of conversions from minimally invasive to thoracotomic procedure
Intraoperative
Margin- and disease-free resection
Time Frame: 1 Month postoperative
Margin- and disease-free resection
1 Month postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operating times
Time Frame: Intraoperative
Evaluation of operating times
Intraoperative
Intraoperative blood loss
Time Frame: Intraoperative
Evaluation of intraoperative blood loss
Intraoperative
Intraoperative major bleeding
Time Frame: Intraoperative
Intraoperative major bleeding
Intraoperative
Intraoperative air leaks and the use of sealants
Time Frame: Intraoperative
Evaluation of intraoperative air leaks and the use of sealants
Intraoperative
Postoperative air leaks
Time Frame: up to 2 weeks
Evaluation of postoperative air leaks
up to 2 weeks
Hospitalization times
Time Frame: up to 3 weeks
Evaluation of hospitalization times
up to 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ospedale Centrale Bolzano

Collaborators

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

Investigators

  • Principal Investigator: ZARACA FRANCESCO, Central Hospital Bolzano

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2023

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

January 11, 2023

First Submitted That Met QC Criteria

January 27, 2023

First Posted (Actual)

February 8, 2023

Study Record Updates

Last Update Posted (Actual)

August 29, 2023

Last Update Submitted That Met QC Criteria

August 26, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1-2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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