DIEP Flap Perfusion Evaluated by DIRT and ICG-FA.

Perforator Mapping and Anastomosis Patency Evaluated by Dynamic Fluorescence Video Angiography of Indocyanine Green and Infrared Thermography.

Patients selected for DIEP breast reconstruction were examined with preoperative CTA, Doppler Ultrasound, dynamic infrared thermography (DIRT) and Indocyanin green fluorescent angiography (ICG-FA) for perforator mapping. DIRT and ICG-FA were used to evaluate perfusion of selected perforators. Following anastomoses for the DIEP flap to internal mammary vessels , patency of the anastomosis was evaluated with DIRT and ICG-FA. Recorded images from all the modules were compared.

Study Overview

• Status: Unknown
• Conditions: Reconstructive Surgical Procedures
• Intervention / Treatment: Diagnostic test: Dynamic infrared thermography (DIRT) and indocyanine green fluorescence angiography (ICG-FA)

Detailed Description

Introduction:

'The primary aim of our study is to compare invasive and non-invasive techniques to select a dominant perforator when harvesting a DIEP-flap for autologous breast reconstruction.

The secondary aim is to compare Dynamic Infrared Thermography (DIRT) and Laser Fluorescence Angiography (LFA) of Indocyanine green (ICG) in order to see whether they could be useful in the early detection of insufficient perfusion following the microvascular anastomotic procedure in DIEP flaps.

Material and Method:

Patients selected for breast reconstruction with autologous tissue were examined with preoperative CTA and a handheld Doppler Ultrasound for perforator mapping. Thereafter visual images from same area was obtained with dynamic infraredeed thermography (DIRT) and Indocyanin green fluorescent angiography (ICG-FA) before and after dissection of the skin flap with preserved medial and lateral DIEP perforators. Reconstructed breasts with hemi-DIEP-flaps were intraoperatively evaluated with DIRT and LFA immediately after the completion and opening of the microvascular anastomosis.The recorded images from the different techniques were assesses in relation to clinical outcome.

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• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

• Study Contact: Name: Louis de Weerd, MD, PhD,; Phone Number: 004777669793; Email: louis.de.weerd@unn.no

Study Locations

• Norway
  • Tromsø, Norway, 9038
    • Recruiting
    • Univesity Hospital of North Norway
    • Contact: Louis de Weerd, MD, PhD; Phone Number: 0047 77669793; Email: louis.De.Weerd@unn.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Female patients selected for autologous breast reconstruction with a DIEP flap.

Description

Inclusion Criteria:

• Post mastectomy.
• Previously breast cancer patent treated with radiation therapy.
• Breast implant reconstruction is not possible or undesired.
• Healthy patient with moderate amounts of abdominal skin laxity.
• Patient who requires a minimal to moderate volume breast reconstruction.
• The patient willing to undergo the long, complex procedure and prolonged postoperative recovery.
• The patient willing to accept an abdominal scar and a potential for donor site morbidities.
• Patients operated with prophylactic salpingo-oophorectomy due to BRCA gene mutation.

Exclusion Criteria:

• Pregnancy and lactation.
• Patents below the age of 18 year.
• Renal failure or hepatic failure.
• Previous allergic reactions to ICG and iodide.
• Abdominal donor site that cannot be closed primarily.
• Previous TRAM flap or abdominoplasty.
• Significant medical comorbidities that make the patient a poor surgical candidate.
• Sigarette smoking or snuff.
• Obesity / BMI > 30.
• Previous abdominal suction-assisted lipectomy.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of quality and location of perforating blood vessels with dynamic infrared thermography and indocyanine green angiography in autologous breast reconstruction: A comparative imaging study.	Pre-and intraoperative use of two different imaging technologies to assess quality and location of perforating blood vessels in autologous breast reconstruction. In this study we will compare images obtained using a non-invasive imaging technique, dynamic infrared thermography and an invasive imaging technique, laser fluorescence angiography of indocyanine green.	2 year
Quality of microvascular anastomosis by measuring perfusion through the anastomosis using dynamic infrared thermography and laser fluorescence angiography of indocyanine green.	The microvascular anastomosis provides blood supply to tissue used in breast reconstruction. The blood flow through the microvascular anastomosis can be monitored by use of different imaging techniques. In this study, perfusion images obtained by non-invasive dynamic infrared thermography and invasive fluorescence angiography of indocyanine green will be compared.	2 years

Collaborators and Investigators

• Sponsor: University Hospital of North Norway
• Collaborators: UiT The Arctic University of Norway

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2019
• Primary Completion (Anticipated): December 24, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: April 16, 2019
• First Submitted That Met QC Criteria: October 3, 2019
• First Posted (Actual): October 4, 2019

Study Record Updates

• Last Update Posted (Actual): October 4, 2019
• Last Update Submitted That Met QC Criteria: October 3, 2019
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Breast reconstruction; Indocyanine green; Doppler ultrasound; Infrared thermography; Computer Tomography; Fluorescence angiography; Perforator flaps; Dynamic infrared thermography; Angiosome; Perforasome; Flap perfusion
• Other Study ID Numbers: 22017/1641

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No