Vacuum-Assisted Evacuation (VAE) Of Symptomatic and/or Voluminous Breast Haematomas Following Surgeries And Percutaneous Procedures: a Retrospective Analysis

Breast Cancer Clinical Trial

Official title:

Vacuum-Assisted Evacuation (VAE) Of Symptomatic and/or Voluminous Breast Haematomas Following Surgeries And Percutaneous Procedures: a Retrospective Analysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05665894
• Other study ID #: BREAST HEMATOMA
• Status: Completed
• Start date: October 1, 2022
• Est. completion date: December 15, 2022

Study information

• Verified date: December 2022
• Source: University of Rome Tor Vergata
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Among postoperative complications in breast surgery, hematoma is the most common occurrence. While mostly self-limited, in some cases surgical revision is mandatory when hematoma occurs. Among percutaneous procedures, preliminary studies demonstrated the efficacy of vacuum-assisted breast biopsy(VAB) in evacuating breast hematomas. The aim of the present study is to investigate the efficacy of VAB system in evacuating hematoma, symptoms resolution, and avoidance of surgery. From January 2016 to January 2020 ≥25 mm symptomatic breast hematoma after breast conserving surgery(BCS) and percutaneous procedures were retrospectively enrolled from a perspective maintained database. Preoperative demographic and clinical data were collected. Hematoma maximum diameter, Estimated hematoma volume, total procedure time, and visual analog scale (VAS) score prior ultrasound(US) Vacuum-Assisted Evacuation (VAEv) were recorded. At one week VAS score, residual hematoma volume, and complications were recorded. Study outcomes were defined as clearance of ≥70% postoperative hematoma, symptoms resolution (assessed as patient report visual analog scale (VAS≤3)), and avoidance of surgery during follow-up.

Description:

A monocentric, retrospective study from a prospectively maintained database was planned to evaluate the clinical outcome of patients undergoing VAB procedures for postoperative breast hematoma between 1st January 2016 and 1st January 2020. Once breast hematoma is diagnosed and FNA did not obtain a complete clearance of the hematoma, in our clinical practice VAEv procedure is planned between 10-14 days from the first procedure (surgery, VAB, VAE). All VAEv procedures are performed in our outpatient department by a radiologist with > 10 years of experience in breast imaging and US-guided procedures. Preoperative assessment is carried out just prior VAEv with high-resolution ultrasound (US) equipment (MyLabTM 9 XP; Esaote SpA, Genoa, Italy) and with 10-13 MHz linear array transducer (Esaote SpA, Genoa, Italy). The patient was placed supine and meticulous aseptic measures were applied. Prior procedure local anesthesia (lidocaine 1%) was administered following disinfection. A 5 mm skin incision is performed to guarantee appropriate access for the needle insertion in the hematomas. The evacuation was achieved using a Mammotome® vacuum-assisted system (Devicor Medical Products, Inc., Cincinnati, OH, USA), with an 8-G needle, under the guidance of the same high-resolution US equipment (MyLabTM 9 XP; Esaote SpA, Genoa) for preoperative assessment. Empty-needle function and the tissue-biopsy option is preferred to fragment the fibrotic tissue until the hematoma empties and its walls collapsed. Once VAEv is performed, the postoperative US is carried out and VAEv is repeated until more than 90% evacuations of hematoma volume if no complication occurs. If the hematoma occurred after the percutaneous procedure (VAB, VAE), a new metal clip is placed in the site of the procedure to locate target breast lesion. At the end of the procedure, the hematoma site is then manually compressed for 5-10 min. Finally, the surgical site is covered with dressings and locoregional ice therapy was applied. Usually, after VAEv patients were observed in our outpatient clinic for 3 hours after the procedure prior to home discharge. All patients were advised to wear tight sports-brassiere was recommended for a minimum of 24 hours to prevent rebleeding or major seroma formation. After VAEv patients are educated regarding our telephonic follow-up for any symptoms onset and are routinely re-evaluated at 1 week with US examination (MyLabTM 9 XP; Esaote SpA, Genoa, Italy) with 10-13 MHz linear array transducer (Esaote SpA, Genoa, Italy), VAS assessment, and postoperative complications. Further telephonic follow-up evaluation is routinely scheduled to avoid late symptomatic breast hematoma underestimation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 15, 2022
• Est. primary completion date: November 15, 2022
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• age between 18 and 75 years old after breast conservative surgery (BCS), VAB or vacuum-assisted excision (VAE) procedure
• Clinically significant and large hematoma (>25 mm) that do not fulfill the criteria for immediate surgery and cause discomfort, pressure symptoms, infection, or pain classified on VAS > 3.
• Failure of attempt with FNA
• Patients that refuse surgery

Exclusion Criteria:

• pregnancy
• patients requiring urgent surgery
• Patient follow-up discontinued in our facility
• Symptomatic post-BCS early hematoma

Related Conditions & MeSH terms

• Breast Cancer
• Breast Diseases
• Hematoma

Intervention

Device:
• Hematoma Vaacum Assisted Biopsy
The patient was placed supine and meticulous aseptic measures were applied. Prior procedure local anesthesia (lidocaine 1%) was administered following disinfection. A 5 mm skin incision is performed to guarantee appropriate access for the needle insertion in the hematomas. The evacuation was achieved using a Mammotome® vacuum-assisted system (Devicor Medical Products, Inc., Cincinnati, OH, USA), with an 8-G needle, under the guidance of the same high-resolution US equipment (MyLabTM 9 XP; Esaote SpA, Genoa) for preoperative assessment. Empty-needle function and the tissue-biopsy option is preferred to fragment the fibrotic tissue until the hematoma empties and its walls collapsed. Once VAEv is performed, the postoperative US is carried out and VAEv is repeated until more than 90% evacuations of hematoma volume if no complication occurs.

Locations

Country	Name	City	State
Italy	Tor Vergata University Hospital	Roma

Sponsors (1)

Lead Sponsor	Collaborator
University of Rome Tor Vergata

Country where clinical trial is conducted

Italy, 

References & Publications (2)

Almasarweh S, Sudah M, Joukainen S, Okuma H, Vanninen R, Masarwah A. The feasibility of ultrasound-guided vacuum-assisted evacuation of large breast hematomas. Radiol Oncol. 2020 Jun 26;54(3):311-316. doi: 10.2478/raon-2020-0041. — View Citation

Guzman-Aroca F, Berna-Serna JD, Garcia-Ortega AA, Hernandez-Gomez D, Berna-Mestre JD. A New Management Technique for Symptomatic Haematomas Following Therapeutic Vacuum-Assisted Biopsy. J Clin Med. 2019 Sep 19;8(9):1493. doi: 10.3390/jcm8091493. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hematoma vacuum assisted biopsy success rate I	Clearance of =70% postoperative hematoma	At the end of the procedure
Primary	Symptom Resolution	Patient report visual analog scale (VAS) =3 (minimum 0; maximum 10) at the end of Hematoma vacuum assisted biopsy	At the end of the procedure
Primary	Hematoma vacuum assisted biopsy success rate I	Avoidance of surgery during follow-up for any reason	30 days from the procedure