Accuracy of Deep Inferior Epigastric Artery Perforator Mapping - Color Doppler Ultrasound Versus CT Angiography

NCT05687006 | Completed

• 1 other identifier: CDU2021
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare the accuracy and contribution of Color Doppler Ultrasound (CDU) guided Deep Inferior Epigastric Artery (DIEA) perforator mapping with or without mapping using Computer Tomography angiography (CTA) in women over 18 years undergoing 2021 unilateral or bilateral breast reconstruction with an abdominal free flap. Participants underwent scheduled reconstruction of one or both breasts with a free flap transferred from the lower abdomen. If there is a comparison group: Researchers compared interventional groups - examined using preoperative CTA of the abdominal wall supplemented with an examination of the perforators using CDU (active comparator group), and examined exclusively by using the CDU (experimental group), to see the comparison of the accuracy and contribution of CDU-guided DIEA perforator mapping with CTA mapping. The hypothesis is that CDU examination alone is not inferior to CTA examination supplemented with parameters that CTA does not show (flow velocity, vessel diameters), by measuring these parameters with CDU. The main questions it aims to answer are:

• To evaluate the comparison of the accuracy of surgeon-conducted CDU perforator mapping in defining the significant/dominant perforators and their exact location \[XY coordinates\] with the accuracy of CTA mapping.
• To compare the time duration of the CDU examination was measured.
• To measure the Fat Necrosis of the flap \[3 months postoperative \]
• To measure the Flap Loss \[1-week post-op, 2 weeks post-op, 6-8 weeks post-op and 3 months post-op\].

Conditions

Mammaplasty

Keywords

CT Angiography; Mammaplasty; Ultrasonography; Doppler

Outcome Measures

Primary Outcomes (2)

• The average deviations (Δ) in localization of perforators in each of the groups [cm]

  In CDU group ΔCDU calculated for each dissected perforator as the Euclidean distance between (before the surgery, using CDU) mapped XY coordinates and the reference XY coordinates measured during the surgery. XY\[0;0\]=umbilicus In CTA+CDU group ΔCTU (because XY coordinates in this group are deducted only based on CTA, CDU in this group is used only as an additional modality to help predict the dissection category A, B, C not to deduct XY coordinates) calculated for each dissected perforator as the Euclidean distance between (before the surgery, using CTA) mapped XY coordinates and the reference XY coordinates measured during the surgery. XY\[0;0\]=umbilicus

  Through study completion, an average of 1 year

• The success rate in estimating proper dissecting strategy [%]

  In what percentage of cases the finally dissected flap category (A, B, C) is the same as the category estimated before the surgery based on CDU or CTA+CDU mapping.

  Through study completion, an average of 1 year

Secondary Outcomes (3)

• The time duration of the CDU examination.

  3 months post-operative

• Fat Necrosis of the flap

  3 months post-operative

• Flap Loss

  1 week post-op, 2 weeks post-op, 6-8 weeks post-op and 3 months post-op

Study Arms (2)

The CTA+CDU Group

NO INTERVENTION

Every patient included in the CTA+CDU group preoperatively underwent CT angiography of the abdominal wall. Based on the CTA examination XY coordinates of DIEA perforators localized within the area between 2 cm cranial and 10 cm caudal from the umbilicus and with a vessel calibre of more than 1 mm were determined. The day before the surgery, the main perforators were marked on the patient's abdomen according to the coordinates deducted from the CTA. These perforators were additionally examined using a LOGIQ S8/V1 CDU device with a linear transducer of frequency 4-11 MHz. Any additional perforators were marked nor have CTA deducted XY coordinates of marked perforators changed based on the CDU examination. The same sonography surgeon performed all CDU examinations. The time duration of the CDU examination was measured.

The CDU Group

EXPERIMENTAL

All patients included in the CDU group were examined a day before the surgery with the same CDU device by the same sonography surgeon as patients included in CTA + CDU group. During the examination, DIEA perforators were mapped and the following parameters were monitored: 1) XY coordinates of DIEA perforators localized within the area between 2 cm cranial and 10 cm caudal from the umbilicus and with a vessel calibre of more than 1 mm; 2) calibres of perforator arteries and veins; 3) PSV in the perforator artery \[cm/s\]; 4) velocity in the perforator vein \[cm/s\]; 5) the thickness of the subcutaneous tissue of the lower abdomen measured 4 cm caudal and lateral to the umbilicus. The time duration of the CDU examination was measured.

Procedure: Colour Doppler Ultrasound

Interventions

Colour Doppler Ultrasound PROCEDURE

The main perforators were examined using a LOGIQ S8/V1 CDU device (GE Healthcare, Chalfont St Giles, Great Britain) with a linear transducer of frequency 4-11 MHz. Measured parameters were: 1) calibre of artery and vein; 2) Peak systolic velocity (PSV) of blood in the artery \[cm/s\]; 3) blood velocity in the perforator vein \[cm/s\]; 2) the thickness of the subcutaneous tissue of the lower abdomen measured 4 cm caudal and lateral to the umbilicus. Any additional perforators were marked nor have CTA deducted XY coordinates of marked perforators changed based on the CDU examination. The same sonography surgeon performed all CDU examinations. The time duration of the CDU examination was measured.

Also known as: CDU

The CDU Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Women undergoing uni- or bilateral breast-free flap reconstruction harvested from the lower abdomen.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• female;
• aged 18 to 65 years;
• undergoing uni- or bilateral breast free flap reconstruction harvested from the lower abdomen;
• signed informed consent to participate in the study.

You may not qualify if:

• history of allergy to iodinated contrast material;
• history of abdominoplasty;
• Body Mass index \> 35;
• active oncological disease ;
• Karnofsky Performance Status \< 50;
• change of the reconstructive method as a result of the preoperative mapping;
• non-standard performed CTA examination.

Sponsors & Collaborators

• St. Anne's University Hospital Brno, Czech Republic: lead
• Masaryk University: collaborator

Study Sites (1)

St. Anne´s University Hospital Brno

Brno, 60200, Czechia

Location

Study Officials

• Libor Streit, MD, PhD.

  St. Anne´s University Hospital Brno

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomization was carried out using an envelope method, during which the patients were randomly assigned in a ratio 1:1 to an active comparator group: "CTA+CDU (preoperative examination of vascular anatomy by CTA supplemented with vessel calibre examination of the perforator using CDU)" or an experimental group: "CDU (preoperative examination of vascular anatomy by colour duplex sonography only)".

Study Record Dates

• First Submitted: December 29, 2022
• First Posted: January 17, 2023
• Study Start: January 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: January 17, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)