Value of Ultrasound-Guided Microwave Ablation for Breast Fibroadenoma (mua)
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Breast fibroadenomas are commonly seen among women worldwide, with the incidence having increased over the past few decades. The breast fibroadenoma arise due to proliferation of ductal or lobular tissue, and their treatment is controversial. Small asymptomatic breast lesions generally do not require treatment, and some surgeons tend to favor conservative management of breast fibroadenoma with regular follow-up, which should be accompanied by auxiliary examination (i.e., ultrasound and/or mammography and pathological assessment) every 3-6 months in order to dynamically monitor the status of breast lesions. However, some patients with large-sized breast fibroadenomas suffering from pain or anxiety are not satisfied with the conservative management approach and seek for treatment. Thus, it is necessary to excise part of the breast fibroadenoma according to therapeutic options that depend on different presenting situations Surgical resection is the most effective treatment option for patients suffering from breast lesions, although it is an invasive procedure. The patients much prefer a better cosmetic outcome and fewer surgically associated complications, which are commonly associated with minimally invasive procedures. Ultrasound-guided percutaneous microwave ablation (MWA) is a new minimally invasive treatment technology used in breast fibroadenoma and has emerged as a hot topic of clinical exploration in recent years. MWA has already shown promising results in treating liver carcinoma and pulmonary tumors, and in the settings of adrenal and renal malignancies Currently, in relation to benign lesions, MWA is considered a promising treatment option for patients with benign thyroid nodules given its advantage of being minimally invasive, scar-free, and relatively safe, and is associated with fewer post-operative complications.
To the best of our knowledge, MWA, as a thermal ablation technique, is increasingly being accepted by surgeons and clearly needs to be evaluated
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
Inclusion criteria:
- Female participants ≥ 18 years
- Diagnosed with fibroadenoma by clinical and ultrasonographic signs, core needle biopsy done only if atypical fibroadenoma.
- Lesion(s) measurable by ultrasound (e.g., diameter 0.7 - 3.0 cm),distance from breast lesion to the skin and pectoralis muscle exceeding 10 mm and the lesion away from nipple areola area .
- Symptomatic lesion or patient preference for minimally invasive treatment
Exclusion criteria:
- Malignancy or high suspicion of malignancy, BIRADs 4 or more/if pathological proved.
- Active infection.
- Coagulopathy or contraindications to ablation.
- Distance from breast lesion to the skin and pectoralis muscle less than 10 mm and the lesion near nipple areola area .
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Sonstiges: breast fibroadenoma
Fibroadenoma is a common benign breast lesion resulting from the excess proliferation of connective tissue.
Fibroadenomas characteristically contain both stromal and epithelial cells.
Fibroadenomas typically occur in women between the ages of 10 and 40 years.
It is the most common solid breast mass in women of all ages and the most common breast mass in the adolescent and young adult population..
The lesions are well-defined and well-circumscribed clinically, with normal overlying skin.
The lesions are not fixed to the surrounding parenchyma and slide around with palpation, hence the colloquial term a breast "mouse".
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Patients will be positioned supine or lateri-cumbent, which fully exposed the breast and permitted surgical disinfection.
During the administration of a local anesthetic, the investigators will carefully administer a mixture of 2% lidocaine and 0.9% saline solution into the surrounding breast fibroadenoma to achieve a liquid isolated region to protect the skin, pectoralis, and areola from thermal injury.
Under real-time ultrasound guidance, an MWA antenna will be inserted into the breast fibroadenoma, and therapy will be ceased until the hyper echoic area completely cover the entire breast fibroadenoma
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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assess the efficacy of MWA in reducing fibroadenoma volume
Zeitfenster: 12 months
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Volume Reduction Ratio (VRR): Calculated to see how much the fibroadenoma has shrunk.
Measure 3 orthogonal diameter, calculate volume: L x W x H x0.5 and compare to previous exam.
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12 months
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To evaluate the safety profile of MWA (adverse events, complications).
Zeitfenster: 18 months
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the investigators will follow up the patients for any appearance of unwanted changes or any complications
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18 months
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Cosmetic outcome - breast shape and symmetry
Zeitfenster: 18 months
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Assessment of breast shape and symmetry using the Breast Symmetry Scale (1-4), where 1 = excellent symmetry and 4 = marked deformity.
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18 months
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Cosmetic outcome - scar appearance
Zeitfenster: 18 months
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Assessment of skin scar quality using the Patient and Observer Scar Assessment Scale (POSAS) or Vancouver Scar Scale.
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18 months
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Cosmetic outcome - skin pigmentation changes
Zeitfenster: 18 months
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Assessment of hyperpigmentation or hypopigmentation at the ablation site compared to the contralateral breast, graded as: 0 = none, 1 = mild, 2 = moderate, 3 = severe.
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18 months
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Patient satisfaction
Zeitfenster: 18 months
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Assessment of patient satisfaction with the overall procedure and cosmetic results using a 5-point Likert scale.
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18 months
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Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- breast fibroadenoma MWA
Plan für individuelle Teilnehmerdaten (IPD)
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Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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