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Status unknownNCT02144961SPYUpdated Mar 24, 2016

The Effects of Indocyanine Green Angiography (IGA) on Deep Inferior Epigastric Artery Perforator (DIEP) Flap Design and Post-Operative Fat Necrosis

An observational study in Breast Cancer, sponsored by University of Washington. Status unknown at 1 site in United States. Open to female participants aged 25 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-03-24.

Sponsored by University of Washington · Observational

The sponsor has not verified this record recently (last verified Mar 2016), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
25 Years to 65 Years
Sex
Female
01

Study summary

The aim of this study is to prospectively evaluate the effect of intra-operative Indocyanine green angiography (IGA) on both flap design and rate of post-operative fat necrosis in patients undergoing autologous breast reconstruction utilizing the Deep Inferior Epigastric Artery Perforator (DIEP) flap.

Read the detailed description

For many post-mastectomy cancer patients seeking breast reconstruction, microsurgical, autologous tissue transfer is a desirable alternative to more conventional, implant-based procedures. In general terms, this technique entails use of one's own tissue, transferred from a distant anatomic site, to recreate the absent breast. This tissue, usually a composite of skin and subcutaneous adipose tissue, is isolated along with its source artery and vein, and transferred to the chest wall where it is connected (anastomosed) to a local blood supply.

Though there have been many donor tissues (flaps) described for this purpose, abdominal tissue supplied by small, perforating blood vessels originating from the deep inferior epigastric artery, has become the microsurgical gold standard. This so-called DIEP flap provides abundant tissue that can be easily sculpted to fill most breast defects with minimal donor site morbidity. Like all microvascular, free tissue transfers, however, the DIEP flap is not without its potential complications. One potential complication that is most distressing to patients occurs when a portion of the subcutaneous adipose tissue transferred exceeds the available blood supply. This devascularized fat eventually undergoes necrosis that may not only complicate the interpretation of future mammograms, but may result in palpable, painful, and occasionally visible, irregularities within the transferred tissue. Though many techniques/interventions/technologies have been described to minimize the incidence of fat necrosis, its occurrence remains frustratingly unpredictable and relatively common, with published rates ranging between 6 and 17 %.

In theory, maximizing perfusion to composite tissue flaps should minimize the rate of fat necrosis. As such, many techniques have emerged in DIEP flap surgery intended to maximize perfusion. One common technique is the use of pre-operative, CT angiography (CTA) to identify the largest and most anatomically favorable perforating vessels to include in the composite tissue transferred. Though elegant in its simplicity, use of this technique has never been demonstrated to decrease the rate of fat necrosis in DIEP reconstructions. In recent years, however, another technology intended to intra-operatively evaluate tissue perfusion has emerged that may prove very beneficial in the realm of microvascular free tissue transfer- Indocyanine green angiography (IGA).

IGA refers to the peripheral venous injection of lyophilized indocyanine green, a contrast agent that fluoresces when excited by a laser of specific wavelength A charge-coupled camera, held above the tissue of interest, can then detect the stimulated fluorescence and project an image of "real-time" tissue perfusion that is proportional to emission intensity. The application of IGA technology in reconstructive plastic surgery, a discipline that relies largely on immediate and accurate assessment of tissue perfusion, has recently generated much discussion.

We believe that perforator selection in DIEP breast reconstructions, a process traditionally dictated at our institution by pre-operative CTA, may be heavily influenced by intra-operative IGA. We further hypothesize that use of intra-operative IGA in DIEP breast reconstructions may reduce the incidence of post-operative fat necrosis.

The aim of this study is to prospectively evaluate the effect of intra-operative Indocyanine Green Angiography (IGA) on both flap design and rate of post-operative fat necrosis in patients undergoing autologous breast reconstruction utilizing the Deep Inferior Epigastric Artery Perforator (DIEP) flap.

02

Conditions studied

  • Breast Cancer

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Keywords

  • breast reconstruction
  • Deep Inferior Epigastric Artery Perforator (DIEP)
  • Indocyanine Green Angiography (IGA)
  • autologous tissue transfer
03

In context

Necrosis

477 studies on the registry are indexed under Necrosis; 54 are open to participants now.

This study's planned enrollment of 100 is close to the median of 100 across 147 observational studies indexed under Necrosis.

Browse Necrosis studies →

Lead sponsor

University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.

Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
25 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Females pursuing breast reconstruction after having undergone mastectomy. In the overwhelming majority of cases, this procedure is indicated for breast cancer treatment. Eligible patients will have their breast reconstruction done at the University of Washington Medical Center.

Inclusion criteria

  1. Female patients at the University of Washington
  2. Aged twenty-five to sixty-five years
  3. Pursuing immediate or delayed, DIEP-based, autologous, microsurgical breast reconstruction at the University of Washington Medical Center

Exclusion criteria

Exclusion Criteria:

  1. Patients unsuitable for autologous, microsurgical breast reconstruction utilizing the DIEP flap - i.e. patients who have undergone prior extensive abdominal surgeries, have inadequate abdominal tissue bulk, who cannot comply with standardized post-operative restrictions / assessments or patients afflicted with a medical condition(s) precluding prolonged general anesthesia and surgery.
  2. Patients who have a known allergy to contrast media will also be excluded from this study.
  3. Patients unable to read and write in English will be excluded.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • Ultrasound

    Breast ultrasound in female patients who are post-mastectomy pursuing autologous tissue breast reconstruction surgery.

06

What researchers measure

Primary outcomes

  1. Rate of post-operative fat necrosis

    Prospectively evaluate the effect of intra-operative IGA on both DIEP flap design, and rate of post-operative DIEP fat necrosis as compared by physical exam and breast ultrasound.

    Time frame: 3-6 months post-operatively

07

Study locations

1 site
  • University of Washington Medical Center
    Seattle, Washington 98195, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 24, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02144961
Lead sponsor
University of Washington
Responsible party
Skye Stewart (Project Manager, University of Washington) — Principal investigator
First posted
May 22, 2014
Start date
Jan 2014
Primary completion
Jan 2017 (estimated)
Completion
Sep 2020 (estimated)
Last update
Mar 24, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

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