Breast CancerNCT02759796
Fluorescence Angiography in the Assessment of DIEP Flap Perfusion
A study testing Tailoring the flap according to clinical assessment and Tailoring the flap according to ICG Angiography assessment in people with Breast Cancer and Vascularization, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer, Vascularization, Fat Necrosis
- What is being tested?
- Tailoring the flap according to clinical assessment and Tailoring the flap according to ICG Angiography assessment
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2015to Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Indocyanine Green Fluorescence Angiography in the Assessment of Deep Inferior Epigastric Perforator (DIEP) Flap Perfusion
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.
- Conditions
- Breast Cancer, Vascularization, Fat Necrosis
- Being tested
- Tailoring the flap according to clinical assessment, Tailoring the flap according to ICG Angiography assessment
- Medical subject headings
- Breast Neoplasms, Neovascularization, Pathologic, Fat Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailoring the flap according to clinical assessmentProcedure or surgery
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 assessmentProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Clinical assessment of flap perfusion | Placebo comparator | Tailoring the flap according to clinical assessment of flap perfusion Receives: Procedure: Tailoring the flap according to clinical assessment |
| Angiography assessment of flap perfusion | Experimental | Tailoring the flap according to ICG Angiography assessment of flap perfusion Receives: Procedure: Tailoring the flap according to ICG Angiography assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with fat necrosis as assessed by physical examination
Measured: Six months postoperatively
Number of participants with fat necrosis as assessed by ultrasonography
Measured: Six months postoperatively
Secondary outcomes (10)
Number of participants with flap failure as assessed by physical examination
Measured: From intraoperative moment to one week postoperatively
Number of participants with wound infection as assessed by physical examination
Measured: From one day postoperatively to two weeks postoperatively
Number of participants with wound healing delay as assessed by physical examination
Measured: From two weeks postoperatively to two months postoperatively
Number of participants with reoperation
Measured: From immediate postoperative moment to one year postoperatively
Flap perfusion index as assessed by IC-CALC software (Pulsion Medical System)
Measured: Intraoperatively
Flap weight (grams)
Measured: Intraoperatively
Flap length (centimeters)
Measured: Intraoperatively
Breast-Q questionnaire (preoperative reconstruction module) to measure patient preoperative status
Measured: A preoperative test in the last week before surgery
Breast-Q questionnaire (postoperative reconstruction module) to measure patient postoperative status
Measured: A postoperative test one year after surgery
ICG security (Number of participants with tachycardia, exanthema and anaphylactic shock as assessed by physical examination and intraoperative monitoring)
Measured: Intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2016 (estimated)
- Study startNov 2015
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luis Landín Jarillo, MD, PhD, Principal investigator, La Paz University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02759796
- Sponsor's protocol ID
- idipaz
- Status last verified
- Apr 2017
- First submitted
- 5 Apr 2016
- Last updated
- 24 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Varela R, Casado-Sanchez C, Zarbakhsh S, Diez J, Hernandez-Godoy J, Landin L. Outcomes of DIEP Flap and Fluorescent Angiography: A Randomized Controlled Clinical Trial. Plast Reconstr Surg. 2020 Jan;145(1):1-10. doi: 10.1097/PRS.0000000000006393.
PubMed 31577664
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indocyanine Green Fluorescence Angiography in the Assessment of Deep Inferior Epigastric Perforator (DIEP) Flap Perfusion
- ClinicalTrials.gov ID
- NCT02759796
- Acronym / sponsor ID
- idipaz
- Conditions
- Breast Cancer, Vascularization, Fat Necrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Instituto de Investigación Hospital Universitario La PazUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 3 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinical assessment of flap perfusion | Placebo comparator | Procedure: Tailoring the flap according to clinical assessmentTailoring the flap according to clinical assessment of flap perfusion |
| Angiography assessment of flap perfusion | Experimental | Procedure: Tailoring the flap according to ICG Angiography assessmentTailoring the flap according to ICG Angiography assessment of flap perfusion |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- DIEP flap bilateral breast reconstruction indication
- Previous abdominoplasty surgery
- Untreated psychiatric disease
- Untreated infection
- Indocyanine green or iodine hypersensitivity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tailoring the flap according to clinical assessmentAfter 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. | Procedure or surgery | Clinical assessment of flap perfusion |
| Tailoring the flap according to ICG Angiography assessmentAfter 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. | Procedure or surgery | Angiography assessment of flap perfusion |
Primary outcome
Number of participants with fat necrosis as assessed by physical examination
Time frame: Six months postoperatively
Number of participants with fat necrosis as assessed by ultrasonography
Time frame: Six months postoperatively
10 secondary outcomes
Number of participants with flap failure as assessed by physical examination
Time frame: From intraoperative moment to one week postoperatively
Number of participants with wound infection as assessed by physical examination
Time frame: From one day postoperatively to two weeks postoperatively
Number of participants with wound healing delay as assessed by physical examination
Time frame: From two weeks postoperatively to two months postoperatively
Number of participants with reoperation
Time frame: From immediate postoperative moment to one year postoperatively
Flap perfusion index as assessed by IC-CALC software (Pulsion Medical System)
Time frame: Intraoperatively
Flap weight (grams)
Time frame: Intraoperatively
Flap length (centimeters)
Time frame: Intraoperatively
Breast-Q questionnaire (preoperative reconstruction module) to measure patient preoperative status
Time frame: A preoperative test in the last week before surgery
Breast-Q questionnaire (postoperative reconstruction module) to measure patient postoperative status
Time frame: A postoperative test one year after surgery
ICG security (Number of participants with tachycardia, exanthema and anaphylactic shock as assessed by physical examination and intraoperative monitoring)
Time frame: Intraoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2017.
- Derived from this study: PubMed 31577664Varela R, Casado-Sanchez C, Zarbakhsh S, Diez J, Hernandez-Godoy J, Landin L. Outcomes of DIEP Flap and Fluorescent Angiography: A Randomized Controlled Clinical Trial. Plast Reconstr Surg. 2020 Jan;145(1):1-10. doi: 10.1097/PRS.0000000000006393.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luis Landín Jarillo, MD, PhD principal investigator
La Paz University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tailoring the flap according to clinical assessment and Tailoring the flap according to ICG Angiography assessment in people with Breast Cancer and Vascularization, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with fat necrosis as assessed by physical examination (time frame: Six months postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02759796, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2017; AzTrials last refreshed its copy on 8 Nov 2026.