Influence of the Superficial Inferior Epigastric System in Deep Inferior Epigastric Perforator (DIEP) Flaps
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Both Superficial Inferior Artery and Vein Clamped
Superficial Inferior Epigastric Vessels both unclamped
SIE Artery Unclamped, Vein Clamped
SIE Artery clamped, Vein unclamped
Sponsored by
About this trial
This is an interventional basic science trial for Breast Cancer focused on measuring DIEP perfusion, Zone IV, Free Flap, Breast Cancer Reconstruction, Perfusion of Zone IV of DIEP flaps
Eligibility Criteria
Inclusion Criteria:
- Female Patient
- Ages 18-70 years old
- Undergoing unilateral DIEP flap reconstruction post mastectomy.
Exclusion Criteria:
- Hyperthyroidism / history of autonomic thyroid adenoma (slightly increased risk of allergic reaction to the dye)
- ASA grade 3+
- Abdominal Scarring
Sites / Locations
- Canniesburn Plastic Surgery Unit, Glasgow Royal Infirmary
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
SIE Vessels Both Clamped
SIE Vessels both Unclamped
SIE Artery Unclamped; Vein Clamped
SIE Artery Clamped, SIE Vein Unclamped
Arm Description
Superficial Inferior Epigastric Artery Clamped; Vein Unclamped
Outcomes
Primary Outcome Measures
Deep Inferior Epigastric Perforator Flap Zone IV Tissue Perfusion
Tissue Perfusion to Zone IV will be assessed intra-operatively using Laser Doppler Imaging and angiography whilst various components of the Contralateral Superficial Inferior Epigastic Artery / Vein are clamped/unclamped.
Secondary Outcome Measures
Full Information
NCT ID
NCT01464970
First Posted
October 30, 2011
Last Updated
May 11, 2012
Sponsor
NHS Greater Glasgow and Clyde
Collaborators
Canniesburn Research Trust
1. Study Identification
Unique Protocol Identification Number
NCT01464970
Brief Title
Influence of the Superficial Inferior Epigastric System in Deep Inferior Epigastric Perforator (DIEP) Flaps
Official Title
The Potential Role of the Superficial Inferior Epigastric Vascular System in the Perfusion of Zone IV of Deep Inferior Epigastric Perforator (DIEP) Flaps
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Unknown status
Study Start Date
December 2011 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
NHS Greater Glasgow and Clyde
Collaborators
Canniesburn Research Trust
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine in-vivo the effects the contralateral superficial inferior epigastric vascular system has on the perfusion of Zone IV of deep inferior epigastric perforator flaps.
Detailed Description
Breast cancer is the commonest cancer to affect women in the UK. Current guidelines state that; disease permitting, all females due to undergo mastectomy for breast cancer should be offered reconstruction. Autologous free tissue transfer using abdominal tissue remains an excellent option for breast reconstruction due the readily available fatty tissue and the low donor site morbidity. In recent years the trend has been to base the abdominal tissue on perforating vessels rather than to routinely harvest muscle along with the flap; thus further potentially reducing donor site morbidity. Abdominal tissue based upon the Deep Inferior Epigastric Perforator (DIEP) system is a well recognised option in breast reconstruction.
This procedure involves harvesting the lower abdominal tissue basing its blood supply on one of the Deep Inferior Epigastric Perforating Arteries and concomitant veins. These are branches of the External iliac artery which perforate through the rectus muscle or the intertendinous intersections.
A large volume of tissue can be harvested based on a single perforator.
Hartrampf divided the abdominal tissues into distinct perfusion zones I-IV based upon their location to the perforating artery. Zone I overlies the perforating vessel, Zone II is across the midline adjacent to perforating vessel. Zone III is on the ipsilateral periphery to the perforating vessel and Zone IV is on the furthest periphery on the contralateral side from the perforator. Over the years this has undergone debate and many have advocated that zones II-III (according to Hartrampfs original classification) should be switched. However everyone remains clear on the term Zone IV. Zone IV is classically the area of the flap which receives least perfusion/drainage from the perforating vessels and as such is most liable to undergo congestion and tissue ischaemia leading to fat/skin necrosis. As such many surgeons routinely excise zone IV from the DIEP flap prior to transfer to the chest defect. This obviously leads to a reduction in the volume of tissue available for reconstruction.
Classically most problems with zone IV / flap perfusion tend to be related to venous congestion.
Many surgeons advocate the use of the superficial inferior epigastric vein as a "lifeboat" vessel in salvaging a congested DIEP and have published their results in doing so.
There are however no in-vivo studies showing the full contribution of the superficial vascular system in flaps based primarily upon the Deep Inferior Epigastric Perforating Vessels. A recent study using preoperative CTs has shown that there are "macrovascular-shunts" between the deep arterial system and the superficial venous system but the implications of this have yet to be established.
Fluoroscopy using indocyanine green is an established method at looking at tissue perfusion in free flaps.
Laser Doppler imaging is another well described technique for the monitoring / assessment of tissue perfusion in plastic surgery operations.
By further understanding the perfusion of the DIEP flaps the investigators hope to improve flap survivability and also the volume of flap which can be used.
Patients due to undergo breast reconstruction with a free DIEP flap by the senior researcher/surgeon will be identified.
On the day of their operation the DIEP flap will be raised as normal on one of the DIEP arteries from either side. The superficial vascular system will be dissected free on the contralateral side.
The flap will then be scanned with Laser Doppler Imaging and then the SPY scanner (indocyanine green angiography coupled with fluoroscopy)
This will take place in a randomized fashion as follows
Superficial Inferior Epigastric Artery Clamped; Vein Unclamped
Superficial Inferior Epigastric Artery Unclamped; Vein Clamped
Both Artery and Vein Clamped
Both Artery And Vein Unclamped
There will be a 5minute pause between each intervention to allow perfusion to stabilize. Previous research (awaiting publication) within our department has shown that this is the necessary amount of time to allow stabilization.
The scanning period will be carried out during the natural rest break of the operating surgeon and as such will not add significantly to the length of the procedure.
Once the scanning process is finished the operation will then proceed as standard with DIEP flap being disconnected from the abdomen and reconnected in the chest to reconstruct the breast.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
DIEP perfusion, Zone IV, Free Flap, Breast Cancer Reconstruction, Perfusion of Zone IV of DIEP flaps
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SIE Vessels Both Clamped
Arm Type
Active Comparator
Arm Title
SIE Vessels both Unclamped
Arm Type
Active Comparator
Arm Title
SIE Artery Unclamped; Vein Clamped
Arm Type
Active Comparator
Arm Title
SIE Artery Clamped, SIE Vein Unclamped
Arm Type
Active Comparator
Arm Description
Superficial Inferior Epigastric Artery Clamped; Vein Unclamped
Intervention Type
Procedure
Intervention Name(s)
Both Superficial Inferior Artery and Vein Clamped
Intervention Description
Perfusion assessed in Zone IV of the DIEP flap whilst both the contralateral Superficial Inferior Epigastric Artery and Vein are clamped
Intervention Type
Procedure
Intervention Name(s)
Superficial Inferior Epigastric Vessels both unclamped
Intervention Description
Perfusion assessed in Zone IV of the DIEP flap whilst both the contralateral Superficial Inferior Epigastric Artery and Vein are unclamped
Intervention Type
Procedure
Intervention Name(s)
SIE Artery Unclamped, Vein Clamped
Intervention Description
Perfusion assessed in Zone IV of the DIEP flap whilst the contralateral Superficial Inferior Epigastric Artery is unclamped and the Vein is clamped
Intervention Type
Procedure
Intervention Name(s)
SIE Artery clamped, Vein unclamped
Intervention Description
Perfusion assessed in Zone IV of the DIEP flap whilst the contralateral Superficial Inferior Epigastric Artery is clamped and the Vein is unclamped
Primary Outcome Measure Information:
Title
Deep Inferior Epigastric Perforator Flap Zone IV Tissue Perfusion
Description
Tissue Perfusion to Zone IV will be assessed intra-operatively using Laser Doppler Imaging and angiography whilst various components of the Contralateral Superficial Inferior Epigastic Artery / Vein are clamped/unclamped.
Time Frame
Intra-Operatively
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Female Patient
Ages 18-70 years old
Undergoing unilateral DIEP flap reconstruction post mastectomy.
Exclusion Criteria:
Hyperthyroidism / history of autonomic thyroid adenoma (slightly increased risk of allergic reaction to the dye)
ASA grade 3+
Abdominal Scarring
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam Gilmour, MBChB, MRCS (Ed)
Organizational Affiliation
Canniesburn Plastic Surgery Unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
Canniesburn Plastic Surgery Unit, Glasgow Royal Infirmary
City
Glasgow
ZIP/Postal Code
G4 0SF
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Influence of the Superficial Inferior Epigastric System in Deep Inferior Epigastric Perforator (DIEP) Flaps
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