Multicentric Risk Evaluation of Autologous Fat Grafting Procedure

Multicentic Retrospective Evaluation of Risks in Mammary Carcinoma Relapse in Patients With Mammary Reconstruction and Autologous Fat Grafting

Autologous fat grafting, also known as lipofilling, is a surgical technique consisting in the processing and transfer of adipose tissue from one area in our organism (hips, thighs) to region which in need of reconstructive and aesthetic correction. The technique is frequently used after radical or conservative mammary surgery, aiming to achieve better aesthetic results, reduce pain induced by both surgery and radiotherapy. The scientific community was widely involved in the debate regarding the use of mesenchymal/stem cells in a patient with high risk of tumor progression due to their elevated proliferative profile. This study aims to retrospectively evaluate the oncological safety in the use of lipofilling in patients who underwent oncological and reconstructive treatment in our Institute.

Study Overview

• Status: Unknown
• Conditions: Pain, Postoperative
• Intervention / Treatment: Procedure: Autologous fat grafting procedure; Procedure: Breast reconstruction

• Study Type: Observational
• Enrollment (Actual): 6510

Contacts and Locations

Study Locations

• Italy
  • Milan
    • Rozzano, Milan, Italy, 20089
      • Istituto Clinico Humanitas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Female patients with breast carcinoma (any histological type, carcinoma in situ included) and treated with radical or conservative surgery and lipofilling. Patients received a minimum of two year follow up.

Description

Inclusion Criteria:

• female
• breast carcinoma (any histological type, carcinoma in situ included) treated with radical or conservative surgery
• group treated with lipofilling and group which didnt receive lipofilling
• timing: retrospective evaluation of cases form 2006 to 2016, with a minimum of two year follow up

Exclusion Criteria:

• neoplasie different from infiltrating and in sutu breast carcinoma
• in situ lobular carcinoma
• patients with breast carcinoma and metastasis
• lipofilling procedure used before the oncological treatment for breast carcinoma

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Women receiving autologous fat grafting; Women who received breast reconstruction and autologous fat grafting.	Procedure: Autologous fat grafting procedure; Surgical intervention based on the injection of autologous fat grafting after radical or conservative breast surgery and breast reconstruction.; Procedure: Breast reconstruction; Breast reconstructive procedures after oncological radical or conservative breast surgery
Control; Women who received breast reconstruction only.	Procedure: Breast reconstruction; Breast reconstructive procedures after oncological radical or conservative breast surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oncological safety of autologous fat grafting	Percentage of disease relapse in loco	Two years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Establishment of timing in disease relapse		Two years
Establish the distribution in disease relapses	Establish the distribution in disease relapse in thre different histological subtypes of breast carcinoma	Two years
Establish overall survival rate in experimental and control groups		Two years

Collaborators and Investigators

• Sponsor: Humanitas Clinical and Research Center
• Investigators: Study Chair: Marco Klinger, MD, Istituto Clinico Humanitas

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2019
• Primary Completion (ANTICIPATED): January 1, 2020
• Study Completion (ANTICIPATED): June 1, 2020

Study Registration Dates

• First Submitted: October 15, 2019
• First Submitted That Met QC Criteria: October 15, 2019
• First Posted (ACTUAL): October 17, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 30, 2019
• Last Update Submitted That Met QC Criteria: October 28, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Breast cancer; Breast reconstruction; Autologous fat grafting; Lipofilling
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 1955K

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No