Clinical trial NCT04115995: DIEP Flap Perfusion Evaluated by DIRT and ICG-FA.
Official title: Perforator Mapping and Anastomosis Patency Evaluated by Dynamic Fluorescence Video Angiography of Indocyanine Green and Infrared Thermography.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Reconstructive Surgical Procedures
Keywords: Breast reconstruction
Perforator flaps
Computer Tomography
Indocyanine green
Fluorescence angiography
Infrared thermography
Dynamic infrared thermography
Doppler ultrasound
Angiosome
Perforasome
Flap perfusion
Lead sponsor: University Hospital of North Norway
Sponsor class: OTHER
Collaborators: name: UiT The Arctic University of Norway
First posted: 2019-10-04
Enrollment: 30
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female patients selected for autologous breast reconstruction with a DIEP flap.

Brief summary: 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.

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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Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 2 year
measure: Quality of microvascular anastomosis by measuring perfusion through the anastomosis using dynamic infrared thermography and laser fluorescence angiography of indocyanine green.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Tromsø
country: Norway
facility: Univesity Hospital of North Norway
Study officials:
References: