Indocyanine Green for Perfusion Assessment of DIEP Flaps

Fat Necrosis Clinical Trial

— FAFI  

Official title:

Indocyanine Green for Perfusion Assessment of DIEP Flaps: A Dutch Multicenter Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05507710
• Other study ID #: NL 68623.058.18
• Status: Recruiting
• Phase: Phase 3
• Start date: May 1, 2019
• Est. completion date: October 1, 2025

Study information

• Verified date: August 2022
• Source: Leiden University Medical Center
• Contact: Alexander L. Vahrmeijer, MD, PhD
• Phone: +31 71 526 2309
• Email: a.l.vahrmeijer[@]lumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Currently during DIEP flap reconstruction, the perfusion of the flap is assessed by the clinical view of the surgeon. Identification of demarcated ischemic zones of the DIEP flap could be optimized by using fluorescence imaging with indocyanine green (ICG) in order to lower the rate of fat necrosis. This study evaluates whether intraoperative perfusion assessment with ICG fluorescence imaging causes a lower rate of fat necrosis compared to conventional intraoperative clinical evaluation of DIEP flaps.

Description:

Rationale: Autologous breast reconstruction after mastectomy due to cancer or prophylactically due to genetically increased risk is frequently performed. A complication that may occur after a deep inferior epigastric artery (DIEP) reconstruction is the occurrence of fat necrosis in the transplanted flap due to ischemia (reperfusion injury). Identification of deep inferior epigastric artery perforators and identification of demarcated ischemic zones of the DIEP flap can be optimized by using fluorescence imaging with indocyanine green (ICG), as has been demonstrated in previous studies. This could result in less fat necrosis, less partial flap loss, and other complications. A randomized controlled trial would be the best study design to assess the value of ICG in determining the perfusion of DIEP flaps, thereby reducing the occurrence of fat necrosis and other complications.

Objective: To determine whether fluorescence imaging using ICG for the assessment of DIEP flap perfusion during surgery decreases the occurrence of fat necrosis compared to standard intraoperative clinical assessment of DIEP flap perfusion.

Study design: This is a two-armed randomized controlled trial:

• interventional arm: evaluation of flap perfusion based on 1) clinical parameters, and 2) fluorescence imaging using ICG

• conventional arm: evaluation of flap perfusion based on clinical parameters only

Study population: Patients scheduled for elective surgery for autologous breast reconstruction, uni- or bilateral, using DIEP or muscle sparing transverse rectus abdominis muscle (msTRAM) flaps. Female patients 18 years of age and older.

Intervention (if applicable): evaluation of flap perfusion based on 1) clinical parameters, and 2) fluorescence imaging using ICG

Main study parameters/endpoints: Difference in percentage of fat necrosis after autologous breast reconstruction using DIEP flaps between patients in whom fluorescence imaging was used and patients in whom flaps were clinically assessed.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 280
• Est. completion date: October 1, 2025
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Female patients 18 years of age and older

2. Who underwent a mastectomy for breast cancer or prophylactic due to genetic predisposition

3. Patients scheduled for elective surgery for autologous breast reconstruction, uni- or bilateral, using DIEP or msTRAM flaps. In case of bilateral breast reconstruction the flaps should be bilateral anastomosed.

4. Written informed consent

Exclusion Criteria:

1. Allergy to ICG, iodine or shellfish

2. Any medical condition that in the opinion of the investigators could potentially jeopardize the safety of the patient

3. Impaired renal function defined as eGFR< 50 mL/min/1.73m2 (this can be seen in the standard preoperative lab results)

Related Conditions & MeSH terms

• Fat Necrosis
• Necrosis

Intervention

Diagnostic Test:
• Near-infrared fluorescence imaging of perfusion
Imaging with ICG near-infrared fluorescence is performed besides clinical judgement of the DIEP flap for perfusion evaluation. Based on fluorescence imaging, additional malperfused area(s) are resected.

Locations

Country	Name	City	State
Netherlands	Leiden University Medical Center	Leiden
Netherlands	Erasmus Medical Center	Rotterdam

Sponsors (1)

Lead Sponsor	Collaborator
Leiden University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical relevant fat necrosis	Clinically relevant fat necrosis is defined as a palpable mass, either painful or not, and with or without aesthetic complaints, and developed within three months after surgery. The following grading system according to Lie et al. is used. Only grade III till IV is classified as clinical relevant fat necrosis.; III: Major compromised reconstructive outcome, flap involvement:15-50%, clinical findings: Major contour defects (multiple), surgical management: Debridement/secondary procedure IV: Subtotal poor reconstructive outcome, flap involvement: >50%, clinical findings: Skin defects, inadequate volume, volume loss, surgical management: Second local flap/ re-intervention initial flap	3 months
Secondary	Quantify perfusion of flaps	Based on NIRF recordings and correlate these to the development of fat necrosis.	3 months
Secondary	Registration of re-interventions	necessary to treat fat necrosis, in numbers and percentages	3 months
Secondary	Registration of postoperative complications	in numbers and percentages	3 months
Secondary	Duration of surgery in minutes	Of all surgical procedures included	1 day
Secondary	Percentage extra resected tissue	of initial flap in grams based on perfusion assessment	1 day
Secondary	Personal experience/opinion of surgeon performing surgery with fluorescent imaging using ICG.	After every surgery the NASA TASK Load Index is taken by the surgeon.	1 day
Secondary	Patient satisfaction	using BREAST-Q questionnaire, this is an validated questionnaire that is used in multiple research for measuring patient satisfaction	3 months