Reconstruction of Partial Mastectomy Defects With Pectoralis Myo-glandular Local Flap.

Phase 1

• Conditions: Breast Cancer
• Interventions: Procedure: Pectoralis myo-glandular flap reconstruction.

• Registration Number: NCT04091958
• Lead Sponsor: Mansoura University

Brief Summary

Increasing number of breast cancer patients are being treated with conservative surgery; without the need for mastectomy. The cosmetic sequel of breast conservative surgery can be unsatisfactory to the patient and may necessitate secondary surgery. The present study aims at improving the cosmetic outcome of breast conservative surgery. The defect remaining in the breast tissue after excision of the tumour will be filled with the underlying pectoralis major muscle. This pilot study will test the safety and efficacy of using the pectoralis major muscle for reconstructing a partial mastectomy defect. fifteen patients with early breast cancer scheduled for breast conservation will be recruited to this study.

Detailed Description

Breast conservative surgery is the standard of care for early breast cancer patients. Large multi-center randomized trials have shown breast conservative surgery to be non-inferior to total mastectomy . Oncoplastic breast surgery consists of adequate tumorectomy followed by aesthetic repair of the partial mastectomy defect to achieve satisfactory cosmetic outcome. Oncoplastic surgery is recommended for all breast conservative operations. Level-I oncoplastic surgery is used to repair minor loss of breast volume. In this level, reconstruction is limited to mobilization and redistribution of the breast parenchyma to fill the tumorectomy defect. Larger volume loss requires complex procedures with significant morbidity and is called level-II oncoplasty. In level-II procedures, extra-mammary tissue is mobilized to fill the breast defect (volume replacement). Alternatively, bilateral reduction mammoplasty procedure (volume displacement) is used to reconfigure the breast, obliterate the tumorectomy defect and correct associated breast hypertrophy or ptosis. With either strategy, volume replacement and volume displacement require extensive skin incisions and tissue mobilization. Thus, level-II oncoplasty achieve maximum aesthetic outcome on the expense of major surgical trauma and significant probability of operative morbidity. Recent years have witnessed renewed interest in de-escalating oncoplastic surgical strategies. Level-I oncoplastic operations have been used more frequently to fulfil the cosmetic needs of the majority of breast conservative operations. Moreover, the patient acceptability of the complex level-II oncoplastic procedures is not universal. With the exception of level-II oncoplastic procedures, breast cancer surgery is a well-tolerated intervention that can be offered in a fast-track or day-case basis with economic, psychological and social advantages.

In view of the above-mentioned considerations, The investigators and others have worked to expand the role of level-I oncoplastic surgery. Several innovative techniques have been recommended to allow repair of wider post-tumorectomy defects with simple mobilization of breast parenchymal flaps.

The pectoralis major muscle flap is the classic workhorse of reconstructive surgery of the head and neck. The muscle has been extensively used as a pedicled or free flap to achieve reconstruction of major post-ablative tissue defects. In aesthetic breast surgery, pectoralis major muscle has been used as a sling to correct breast ptosis.

The investigators hypothesized that mobilization of glandular tissue based on underlying pectoralis major fibres will allow repair of larger defects using an "extended level-I oncoplasty". Pectoralis major is known to have reliable segmental blood supply that allows muscle-sparing flap construction with minimal or no functional deficit.

The aim of this work is to evaluate the operative and aesthetic outcome of extended-level-I oncoplastic reconstruction with pectoralis myo-parenchymal flaps.

This is a pilot study that is equivalent to a phase I trial i.e. a safety study. The primary goal is to identify unforeseen surgical, oncologic or cosmetic drawbacks for the technique. This study will also evaluate the efficacy of the technique for providing satisfactory cosmetic outcome.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-08-24
• Study First Submitted: 2019-09-13
• Study First Submitted QC: 2019-09-14
• Study First Posted: 2019-09-17
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-18
• Last Update Posted: 2020-11-19
• Primary Completion: 2021-01-30
• Study Completion: 2022-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 15

Inclusion Criteria

1. Patients with early breast cancer or phylloides tumor.
2. Eligible for breast conservative surgery.
3. Expected post-lumpectomy volume loss of 20-40% of breast volume.
4. Tumor location in upper quadrants.
5. Informed consent.

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Exclusion Criteria

1. Patient refusal.

2. Contraindication of breast conservative therapy:

   1. Pregnancy.
   2. Diffuse microcalcifications.
   3. Patient choice for mastectomy.
   4. Collagen / vascular disease.
   5. Multicentric tumor.

3. Psychological co-morbidity.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Post-tumourectomy reconstruction with myo-glandular flap.	Pectoralis myo-glandular flap reconstruction.	Standard tumourectomy followed by reconstruction with myo-glandular flap.

Primary Outcome Measures

Name	Time	Method
The rate of major complications	Six weeks after surgery.	The rate of major complications related to surgery that necessitate further intervention.
The score of early cosmetic outcome	Six weeks after surgery.	This is a categorical variable. The cosmetic score is reported according to the Harris method. In this method the overall cosmetic result is ranked as one of four scores. The maximum score is "Excellent" where the treated breast is identical to the other breast. Slight difference is scored as "Good". Marked difference without distortion is scored as " Fair". The least score is " Poor" where there is breast distortion.

Secondary Outcome Measures

Name	Time	Method
The score of late cosmetic outcome	12 Months after surgery.	This is a categorical variable. The cosmetic score is reported according to the Harris method. In this method the overall cosmetic result is ranked as one of four scores. The maximum score is "Excellent" where the treated breast is identical to the other breast. Slight difference is scored as "Good". Marked difference without distortion is scored as " Fair". The least score is " Poor" where there is breast distortion.

Trial Locations

Locations (1)

Mansoura University Oncology Center; 🇪🇬 Mansourah, DK, Egypt