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A Clinical Trial of Diagnostic Photoacoustic Imaging System in the Planning of Free Flap Surgery

A Clinical Trial of Photoacoustic Imaging in the Planning of Free Flaps

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13 patients undergoing breast reconstruction using an abdominal flap, 13 patients undergoing head and neck reconstruction using a thigh flap, and 1 patient undergoing hand reconstruction using a lower abdominal wall flap.

Although the number of cases in the research protocol was 54, the research goals including creating a vascular map sheet based on photoacoustic imaging and demonstration of the accuracy of the vascular map sheet were achieved.

No disease or adverse events

We evaluated the visibility and handling of vascular map sheet created using photoacoustic imaging. There were no problems with its use before or during surgery. The accuracy of the vascular map sheet was evaluated. There was an agreement between the positions of the perforating vessels on the sheet and actual positions of the vessels.

This study was conducted on 13 patients who underwent a breast reconstruction using an abdominal flap, 13 patients who underwent head and neck reconstruction using a thigh flap, and 1 patient with post-burn keloid scars who were eligible for skin replacement surgery using a superficial epigastric artery flap. Visibility and handling of photoacoustic-imaging-based vascular map sheets were good, and the positions of perforators on the map sheets matched the actual positions of blood vessels.

Mar. 31, 2024

May. 18, 2023

https://www-sciencedirect-com.kyoto-u.idm.oclc.org/science/article/pii/S1748681523002607

No

none

https://jrct.mhlw.go.jp/latest-detail/jRCTs052200139

Saito Susumu

Kyoto University Hospital

54 Kawaharacho Shogoin Sakyoku Kyoto

susumus@kuhp.kyoto-u.ac.jp

Yoshiko Nagai

Kyoto University Hospital

54 Kawaharacho Shogoin Sakyoku Kyoto

+81-75-751-3613

y_nagai@kuhp.kyoto-u.ac.jp

Complete

Feb. 19, 2021

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

diagnostic purpose

1. Patients who are planned to undergo reconstructive surgeries using flaps at Kyoto Univ.'s Hospital
2. Aged 20 years or older at the time of the informed consent

1. Pregnant or lactating women
2. Photosensitizer for photodynamic therapy
3. A cardiac pacemaker in their body
4. Severe systemic disease corresponding to ASA-PS (American Society of Anesthesiologists physical status classification) Class 4 or larger.
5. Infection at the examined body sites
6. Difficult in communicating or body positioning during examinations

Both

conditions requiring reconsructive surgeries using free flaps

The use of photoacoustic imaging in the planning of free flaps

Head and neck cancer, Breast cancer

diagnostic imaging system

C04

Subjective evaluation (visibility and ease of use of vascular map)
Objective evaluation (accuracy of the location of perforators)

Visual properties of perforating vessels
Anatomical variations of vessels
Correspondence of findings from photoacoustic imaging and those in ICG tests during surgery

+81-75-753-4680

Feb. 08, 2021

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