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Breast CancerGRISOTTI FLAPNCT07293052

Comparison of Outcome Between Grisotti Flap Versus Reverse Mirror Grisotti Flap for Central Quadrant Breast Tumors

A study testing Grisotti Flap and Reverse Mirror Grisotti Flap in people with Breast Cancer and Breast Reconstruction, run by Mayo Hospital Lahore at 1 site in Pakistan.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Breast conservation surgery is equivalent to mastectomy for early stage breast cancer patients. Central quadrant tumours can be treated with various oncoplastic techniques with a satisfactory aesthetic outcome and low morbidity. Read more about this study

Who is it for?
Ages 25 to 70 years, women only
Conditions the study is for
Breast Cancer, Breast Reconstruction
What is being tested?
Grisotti Flap and Reverse Mirror Grisotti Flap
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
106 participants
Where
1 sitePakistan
Study dates
4 Nov 2025to 4 May 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 25 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosed cases of breast cancer patients
  • Gender: Females
  • Age: 25-70 years
  • T1 (<2cm) and T2 (2-5cm) tumors with or without prior systemic therapy
  • Tumor located in the NAC or located within 2 cm of the edge of the areola

Who cannot join

  • Metastatic breast cancer
  • Inflammatory breast cancer
  • Patients not willing for post-operative radiotherapy
  • High tumour-breast ratio

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • King Edward Medical University

    Lahore, Punjab Province, 54000

Other trials in Pakistan

About this study

Breast conservation surgery is equivalent to mastectomy for early stage breast cancer patients. Central quadrant tumours can be treated with various oncoplastic techniques with a satisfactory aesthetic outcome and low morbidity. Grisotti flap and reverse mirror grisotti flap are the favourable viable surgical options for central quadrant breast tumours. our hypothesis is that there is a difference in the outcome between Grisotti versus Reverse Mirror Grisotti flap in centrally located breast cancers.

Read the detailed description

Breast cancer amongst women is the most common cancer and the second leading cause of deaths related to cancer worldwide.6 Its incidence is rising by 1% annually during 2012-2021, largely confined to localized-stage and hormone receptor-positive disease.1 A steeper increase in women < 50 years (1.4% annual) versus >50 years (0.7%) overall was significant only among White women. African/Pacific Islander women had the fastest increase in both age groups (2.7% for women <50 years and 2.5% for women > 50 years per year)1. Hence, young Asian ,American/Pacific Islander women had the second lowest rate in 2000 (57.4 per 100,000) but the highest rate in 2021 (86.3 per 100,000). 1 In a multitude of developed and emerging countries, including Pakistan, breast cancer is a cause of significant morbidity and mortality.1,2 The average age of developing a breast cancer among white American women is 61 years, however the average age for Pakistani women is 51.4 years.2 In the past, mastectomy was treatment of choice for any stage of breast cancer.9 However newer advancements resulting in early diagnosis, providing advancved systemic therapies and easy availability of radiotherapy facilities have paved the paths for breast conservations.7,9 Sometimes the size and location of the tumor leads to undesired aesthetic results which can be encountered when attempting resections with safe margins. The major part of the aesthetic problem after breast conservation surgery is due to large glandular defects and scars contractures.15 This is where oncoplastic techniques are used for the repair of resulting glandular defects without compromising the oncological outcomes.7,9,15 Breast oncoplastic surgery, integrating oncologic and plastic surgery principles, is increasingly prevailing in developed as well as developing countries. The technique involves precise and thorough planning of incisions,excisions, glandular reshaping and nipple areolar complex (NAC) repositioning for improved and symmetrical aesthetic outcomes.3 Oncoplastic breast surgery has hence become the standard of care in breast cancer owing to its feasibility,advances and oncological safety .5 Among the different quadrant tumours, centrally located breast tumours (CLBT) account for about 5-20% of all breast cancer cases.7,9 Because of their location CLBT pose special oncological and aesthetic concerns. Selecting an optimal surgical approach for CLBT remains debated till date, reflecting the complexity of balancing oncologic principles with aesthetic outcomes and local control.3 The resection of NAC is almost always necessary in central quadrant tumours and aesthetic outcomes are mostly poor if only a standard breast conservative therapy is performed.14 Oncoplastic approaches for centrally located breast tumours may include Grisotti flap, reverse mirror grisotti flap, latissimus dorsi flap, inferior pedicle flap, Melon slice, and round block techniques16. For centrally located breast tumours Grisotti flap technique has a short learning curve, quick to perform, with a low complication rate, satisfactory cosmetic outcome and no loss of body image in the post-operative period making it a more physiological procedure.7,13 The oncologic outcome of oncoplastic breast conservation was shown to be comparable to the classical mastectomy in cases of central breast tumors 10. The Grisotti technique consists of excising central quadrant breast tumor alongwith nipple areolar complex and mobilizing a dermo-glandular flap which is de-epithelized, rotated and advanced based on inferior and lateral pedicle in order to fill the glandular defect and reshape the breast, recreating a neo-areola.8,9 Grisotti flap is a partial mastectomy and an immediate volume replacement technique10 The Grisotti flap technique demonstrated superior patient satisfaction alongwith aesthetic and psycho-social outcomes while maintaining oncological safety that is comparable to that of mastectomy.Hence Grisotti flap technique is a standard alternative to mastectomy, particularly in patients prioritizing aesthetic outcomes. 4,6 Advances in oncoplastics have devised the modification of this original technique which involves the utilizing other vascular pedicles for the dermoglandular advancement and rotation.9 A reverse-mirror Grisotti flap, also known as a Reverse-Bay of Bengal modification, is a variation of the Grisotti flap technique used in breast cancer surgery. It is designed to reconstruct defects in the central breast quadrant after a breast conservation surgery. This modification involves re-orienting the flap medially where it is dependent mainly on the perforators of internal mammary artery for blood supply, potentially offering better aesthetic results and more versatile and robust blood supply. The Grisotti flap, despite its well known utility, has limitations, particularly in patients with non-ptotic breasts, where it may lead to fullness laterally and suboptimal cosmesis, the Reverse Bay of Bengal modification of the Grisotti flap is designed to address these limitations by preserving chest wall perforators and avoiding excessive lateral buldging.11 This technique hence offers a more cosmetic alternative for patients with central quadrant tumors requiring nipple-areola complex (NAC) excision.11

Being tested
Grisotti Flap, Reverse Mirror Grisotti Flap
Keywords
Central Quadrant Breast, Grisotti flap, Reverse Mirror Grisotti Flap
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Grisotti FlapProcedure or surgery

    The Grisotti flap is a local rotational flap used to reconstruct defects after removing a central breast cancer, often involving the nipple-areola complex (NAC). It uses tissue from the inferior pole of the breast to fill the central defect. The dermoglandular flap will be raised on infero-lateral perforators of intercostal arteries and will be rotated and advanced to fill the gap .

  • Reverse Mirror Grisotti FlapProcedure or surgery

    The reverse-mirror version is a modification where the flap is flipped and reoriented, using the internal mammary vessels as the primary blood supply. The dermoglandular flap will be raised on the medial perforators of internal mammary artery and will be rotated and advanced to fill the defect.

Study groups in NCT07293052
Study groupRoleWhat they receive
Grisotti FlapExperimentalGrisotti flap will be used in this arm for the oncoplastic breast surgery.
Receives: Procedure: Grisotti Flap
Reverse Mirror Grisotti flapActive comparatorReverse Mirror Grisotti flap will be used in this group for the oncoplastic breast surgery.
Receives: Procedure: Reverse Mirror Grisotti Flap

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Flap viability

    Absence of necrosis of new areola formed as seen clinically at 48 hours and 7th day postoperatively.

    Flap viability categories:

    A (None): No necrosis. B (Color Change): Color change suggesting impaired perfusion or ischemic injury.

    C (Partial Thickness): Partial thickness skin flap necrosis resulting in wound breakdown.

    D (Full Thickness): Full thickness skin flap necrosis.

    Measured: 7 days

Secondary outcomes (2)
  1. Cosmetic outcome

    Cosmetic outcome will be explained with VAS (visual analogue scale) by the patient. The scale will range from 0-10 with 0 being categorized as worst cosmetic outcome and 10 being categorized as best cosmetic outcome.

    Measured: 7 days

  2. Seroma formation

    Seroma formation is the visible swelling at the operative site which will be confirmed and quantified by ultrasound on 7th post operative day with volume more than 20ml.

    Measured: 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Dec 2025
  2. Study start4 Nov 2025
  3. Primary completion4 May 2026 (estimated)
  4. Study completion4 May 2026 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
106 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07293052
Sponsor's protocol ID
MayoLahore
Acronym
GRISOTTI FLAP
Status last verified
Dec 2025
First submitted
26 Nov 2025
Last updated
18 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Informed consent will be obtained from all individual participants with diagnosis of central quadrant breast tumors as per operational definition, and data will be collected on predesigned proforma. Information will include name, age, gender, medical registration number, contact and residence.

Publications

  • Abdelkader AA, El-Fayoumi T, Roushdy A, Asal MF. Comparison between conventional and oncoplastic breast surgeries regarding resection margins and local recurrences in breast cancer: Retrospective study. The Egyptian Journal of Surgery. 2023; 7;42(4).

  • Ozgul H, Celik O, Sakar B, Celik A, Oener OZ. Postoperative patient satisfaction and oncological Outcomes of Grisotti flap vs. Total mastectomy: A retrospective analysis

  • Koppiker CB, Noor AU, Joshi S, Mishra R, Sivadasan P, Sheikh S., et al.Pushing the Boundaries for Centrally Located Breast Tumors in Oncoplastic Breast Surgery: A Single Centre Audit. medRxiv. 2024 ; 25:2024-11.

  • Siddiqui R, Alsuwaidi SA, Irkorucu O, Mehmood MH, Khan NA. The Increasing Importance of Breast Cancer in the United Arab Emirates. Asia Pac J Clin Oncol. 2025 Nov 15. doi: 10.1111/ajco.70050. Online ahead of print.

    PubMed 41241761
  • Giaquinto AN, Sung H, Newman LA, Freedman RA, Smith RA, Star J, Jemal A, Siegel RL. Breast cancer statistics 2024. CA Cancer J Clin. 2024 Nov-Dec;74(6):477-495. doi: 10.3322/caac.21863. Epub 2024 Oct 1.

    PubMed 39352042

Questions about this trial

What is this clinical trial studying?

A study testing Grisotti Flap and Reverse Mirror Grisotti Flap in people with Breast Cancer and Breast Reconstruction, run by Mayo Hospital Lahore at 1 site in Pakistan.

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 5 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 18 Dec 2025. 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 Pakistan. 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?

This study is still under way. Results are not available in the source record yet.

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?

Flap viability (time frame: 7 days). 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 NCT07293052, which also lists 5 linked publications.

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 18 Dec 2025.

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