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.
ID
Source
Brief title
Condition
- Skin and subcutaneous tissue therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Percentage clinically relevant fat necrosis, defined as a palpable mass, either
painful or not, and with or without aesthetic complaints, and developed within
three months after surgery.
Secondary outcome
• Registration of re-interventions necessary to treat fat necrosis, in numbers
and percentages
• Registration of postoperative complications, in numbers and percentages
• Duration of surgery in minutes
• Percentage extra resected tissue of initial flap in grams based on perfusion
assessment
• Personal experience/opinion of surgeon performing surgery with fluorescent
imaging using ICG. This is graded using the NASA TASK questionnaire.
• Patient satisfaction using BREAST-Q questionnaire
Background summary
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.
Study 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 burden and risks
The surgery of the patients included in the invervention arm will be extended
with approximately 20 minutes to perform NIRF imaging with ICG.
Patients may not be included in case they have an allergy for ICG or Iodine, or
schellfish because an allergic reaction might occur. This is described in the
literature in <1:40000 patients, and in case an allergy happens this will be a
sensitivity reaction of the skin.
The risk will be negligible.
Furthermore, patients will have to take a BREAST-Q questionnaire, this will
cost them max 10 minutes.
Albinusdreef 2
Leiden 2333ZA
NL
Albinusdreef 2
Leiden 2333ZA
NL
Listed location countries
Age
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
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
4. Adjuvant systemic chemo- and/or local radiotherapy in the 3 months after
the DIEP-procedure.
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT05507710 |
| CCMO | NL68623.058.18 |