DIEP Flap Perfusion Evaluated by DIRT and ICG-FA.

NCT ID: NCT04115995

Last Updated: 2019-10-04

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-01-16
• Study Completion Date: 2019-12-31

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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Conditions

Reconstructive Surgical Procedures

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Dynamic infrared thermography (DIRT) and indocyanine green fluorescence angiography (ICG-FA)

DIRT and ICG FA are used intraoperatively to evaluate perfusion of the perforators and the anastomosis. Both technique are compared in their ability to visualize perfusion.

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

UiT The Arctic University of Norway

OTHER

Sponsor Role: collaborator

University Hospital of North Norway

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Univesity Hospital of North Norway

Tromsø, , Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Louis de Weerd, MD, PhD,

Role: CONTACT

louis.de.weerd@unn.no

004777669793

Facility Contacts

Louis de Weerd, MD, PhD

Role: primary

louis.De.Weerd@unn.no

0047 77669793

Other Identifiers

22017/1641

Identifier Type: -

Identifier Source: org_study_id