Fluorescence Angiography in the Assessment of DIEP Flap Perfusion

Breast Cancer Clinical Trial

Official title:

Indocyanine Green Fluorescence Angiography in the Assessment of Deep Inferior Epigastric Perforator (DIEP) Flap Perfusion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02759796
• Other study ID #: idipaz
• Status: Completed
• Phase: N/A
• First received: April 5, 2016
• Last updated: April 21, 2017
• Start date: November 2015
• Est. completion date: April 2017

Study information

• Verified date: April 2017
• Source: Instituto de Investigación Hospital Universitario La Paz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

It is a single-center, prospective, randomized and controlled study focused in microsurgical autologous breast reconstruction. It involves applying indocyanine green (ICG) angiography for the study of the vascularization of DIEP flaps. The aim of the study is to determine whether there are differences in complications and aesthetic results when ICG is used to discard the poorly vascularized areas of the flap. The study includes adult women undergoing unilateral DIEP flap breast reconstruction. The calculated sample size is 60 patients. There are two groups. In group 1, the investigators use the usual clinical criteria to discard the poorly vascularized areas of the flap. In group 2, the investigators use the ICG to shape the flap.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Mastectomized adult female patient

• Abdominal flap unilateral breast reconstruction indication

• Alloplastic breast reconstruction sequelae

• Enough amount of abdominal dermofat tissue to shape a breast with a primary closure of the donor site

Exclusion Criteria:

• DIEP flap bilateral breast reconstruction indication

• Previous abdominoplasty surgery

• Untreated psychiatric disease

• Untreated infection

• Indocyanine green or iodine hypersensitivity

• Hyperthyroidism, thyroid adenoma or thyroid autonomy

• Any concomitant disease or condition that, in the opinion of the investigator, can make the patient unsuitable to receive a microsurgical technique or to join the research.

Related Conditions & MeSH terms

• Breast Cancer
• Fat Necrosis
• Necrosis
• Neovascularization, Pathologic
• Vascularization

Intervention

Procedure:
• Tailoring the flap according to clinical assessment
After microvascular anastomosis is performed, the investigators clinically assess flap vascularization and the well vascularized tissue is marked by means of a dermographic pencil. Then the investigators administer 0,2mg/kg of ICG intravenously. The vascularization of the flap is also checked by means of the Photo Dynamic Eye (Pulsion Medical System) but finally the decision of discarding the poorly vascularized areas of the flap is made by clinical assessment.
• Tailoring the flap according to ICG Angiography assessment
After microvascular anastomosis is performed, the investigators administer 0,2mg/kg of ICG intravenously. Then the investigators check the vascularization of the flap by means of the Photo Dynamic Eye (Pulsion Medical System) and the poorly vascularized areas of the flap are discarded guided by ICG perfusion test.

Locations

Country	Name	City	State
Spain	La Paz University Hospital	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Investigación Hospital Universitario La Paz

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with fat necrosis as assessed by physical examination		Six months postoperatively
Primary	Number of participants with fat necrosis as assessed by ultrasonography		Six months postoperatively
Secondary	Number of participants with flap failure as assessed by physical examination		From intraoperative moment to one week postoperatively
Secondary	Number of participants with wound infection as assessed by physical examination		From one day postoperatively to two weeks postoperatively
Secondary	Number of participants with wound healing delay as assessed by physical examination		From two weeks postoperatively to two months postoperatively
Secondary	Number of participants with reoperation		From immediate postoperative moment to one year postoperatively
Secondary	Flap perfusion index as assessed by IC-CALC software (Pulsion Medical System)		Intraoperatively
Secondary	Flap weight (grams)		Intraoperatively
Secondary	Flap length (centimeters)		Intraoperatively
Secondary	Breast-Q questionnaire (preoperative reconstruction module) to measure patient preoperative status		A preoperative test in the last week before surgery
Secondary	Breast-Q questionnaire (postoperative reconstruction module) to measure patient postoperative status		A postoperative test one year after surgery
Secondary	ICG security (Number of participants with tachycardia, exanthema and anaphylactic shock as assessed by physical examination and intraoperative monitoring)		Intraoperatively