Breast CancerNCT01464970
Influence of the Superficial Inferior Epigastric System in Deep Inferior Epigastric Perforator (DIEP) Flaps
A study testing Both Superficial Inferior Artery and Vein Clamped, Superficial Inferior Epigastric Vessels both unclamped and SIE Artery Unclamped, Vein Clamped in people with Breast Cancer, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Both Superficial Inferior Artery and Vein Clamped, Superficial Inferior Epigastric Vessels both unclamped and SIE Artery Unclamped, Vein Clamped
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2011to Dec 2012
- 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
- Female Patient
- Ages 18-70 years old
- Undergoing unilateral DIEP flap reconstruction post mastectomy.
Who cannot join
- Hyperthyroidism / history of autonomic thyroid adenoma (slightly increased risk of allergic reaction to the dye)
- ASA grade 3+
- Abdominal Scarring
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Canniesburn Plastic Surgery Unit, Glasgow Royal Infirmary
Glasgow, G4 0SF
About this study
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
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Both Superficial Inferior Artery and Vein Clamped, Superficial Inferior Epigastric Vessels both unclamped, SIE Artery Unclamped, Vein Clamped, SIE Artery clamped, Vein unclamped
- Keywords
- DIEP perfusion, Zone IV, Free Flap, Breast Cancer Reconstruction, Perfusion of Zone IV of DIEP flaps
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Both Superficial Inferior Artery and Vein ClampedProcedure or surgery
Perfusion assessed in Zone IV of the DIEP flap whilst both the contralateral Superficial Inferior Epigastric Artery and Vein are clamped
Superficial Inferior Epigastric Vessels both unclampedProcedure or surgery
Perfusion assessed in Zone IV of the DIEP flap whilst both the contralateral Superficial Inferior Epigastric Artery and Vein are unclamped
SIE Artery Unclamped, Vein ClampedProcedure or surgery
Perfusion assessed in Zone IV of the DIEP flap whilst the contralateral Superficial Inferior Epigastric Artery is unclamped and the Vein is clamped
SIE Artery clamped, Vein unclampedProcedure or surgery
Perfusion assessed in Zone IV of the DIEP flap whilst the contralateral Superficial Inferior Epigastric Artery is clamped and the Vein is unclamped
| Study group | Role | What they receive |
|---|---|---|
| SIE Vessels Both Clamped | Active comparator | Not described Receives: Procedure: Both Superficial Inferior Artery and Vein Clamped |
| SIE Vessels both Unclamped | Active comparator | Not described Receives: Procedure: Superficial Inferior Epigastric Vessels both unclamped |
| SIE Artery Unclamped; Vein Clamped | Active comparator | Not described Receives: Procedure: SIE Artery Unclamped, Vein Clamped |
| SIE Artery Clamped, SIE Vein Unclamped | Active comparator | Superficial Inferior Epigastric Artery Clamped; Vein Unclamped Receives: Procedure: SIE Artery clamped, Vein unclamped |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Intra-Operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2011 (estimated)
- Study startDec 2011
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- Canniesburn Research Trust
- Responsible party
- Principal investigator, Adam Gilmour, NHS Greater Glasgow and Clyde
- Investigators
- Adam Gilmour, MBChB, MRCS (Ed), Principal investigator, Canniesburn Plastic Surgery Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01464970
- Sponsor's protocol ID
- GN11CA415
- Status last verified
- May 2012
- First submitted
- 30 Oct 2011
- Last updated
- 14 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01464970
- Acronym / sponsor ID
- GN11CA415
- Conditions
- Breast Cancer
- Keywords
- DIEP perfusion, Zone IV, Free Flap, Breast Cancer Reconstruction, Perfusion of Zone IV of DIEP flaps
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- Canniesburn Research Trust
- Study start
- Dec 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 4 Nov 2011 (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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SIE Vessels Both Clamped | Active comparator | Procedure: Both Superficial Inferior Artery and Vein Clamped |
| SIE Vessels both Unclamped | Active comparator | Procedure: Superficial Inferior Epigastric Vessels both unclamped |
| SIE Artery Unclamped; Vein Clamped | Active comparator | Procedure: SIE Artery Unclamped, Vein Clamped |
| SIE Artery Clamped, SIE Vein Unclamped | Active comparator | Procedure: SIE Artery clamped, Vein unclampedSuperficial Inferior Epigastric Artery Clamped; Vein Unclamped |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female Patient
- Ages 18-70 years old
- Undergoing unilateral DIEP flap reconstruction post mastectomy.
Key exclusion criteria (3 listed)
- Hyperthyroidism / history of autonomic thyroid adenoma (slightly increased risk of allergic reaction to the dye)
- ASA grade 3+
- Abdominal Scarring
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 |
|---|---|---|
| Both Superficial Inferior Artery and Vein ClampedPerfusion assessed in Zone IV of the DIEP flap whilst both the contralateral Superficial Inferior Epigastric Artery and Vein are clamped | Procedure or surgery | SIE Vessels Both Clamped |
| Superficial Inferior Epigastric Vessels both unclampedPerfusion assessed in Zone IV of the DIEP flap whilst both the contralateral Superficial Inferior Epigastric Artery and Vein are unclamped | Procedure or surgery | SIE Vessels both Unclamped |
| SIE Artery Unclamped, Vein ClampedPerfusion assessed in Zone IV of the DIEP flap whilst the contralateral Superficial Inferior Epigastric Artery is unclamped and the Vein is clamped | Procedure or surgery | SIE Artery Unclamped; Vein Clamped |
| SIE Artery clamped, Vein unclampedPerfusion assessed in Zone IV of the DIEP flap whilst the contralateral Superficial Inferior Epigastric Artery is clamped and the Vein is unclamped | Procedure or surgery | SIE Artery Clamped, SIE Vein Unclamped |
Primary outcome
Deep Inferior Epigastric Perforator Flap Zone IV Tissue Perfusion
Time frame: Intra-Operatively
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2012.
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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.
Adam Gilmour, MBChB, MRCS (Ed) principal investigator
Canniesburn Plastic Surgery Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Both Superficial Inferior Artery and Vein Clamped, Superficial Inferior Epigastric Vessels both unclamped and SIE Artery Unclamped, Vein Clamped in people with Breast Cancer, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 14 May 2012. 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 United Kingdom. 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. 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?
Results are not available in the source record.
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?
Deep Inferior Epigastric Perforator Flap Zone IV Tissue Perfusion (time frame: Intra-Operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 May 2012.