Clinical Trial

EXpander-based Versus Direct to Implant PRE-pectoral Breast Reconstruction: a Comparative Analysis of Surgical Outcomes

Study acronym: EXPRESSO
Not Yet Recruiting
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Summary
Recent advances in breast surgery, together with the increasing adoption of conservative surgical approaches, have renewed interest in pre-pectoral implant-based breast reconstruction. Within this reconstructive paradigm, surgeons may employ two distinct strategies: (i) immediate reconstruction using a direct-to-implant approach (DTI), or (ii) a two-stage reconstruction consisting of tissue expander placement followed by definitive implant insertion (TE-I). Each approach is associated with specific indications, advantages, and inherent limitations. The EXPRESSO study aims to retrospectively compare surgical outcomes between pre-pectoral DTI and TE-I breast reconstruction. By providing real-world evidence on these reconstructive strategies, this study seeks to inform surgical decision-making and to optimize reconstructive outcomes in contemporary breast cancer care.
Trial Details
NCT Number NCT07593651
Lead Sponsor IRCCS San Raffaele
Collaborators: Regional Hospital Lugano (EOC), Switzerland
Conditions Breast Cancer, Operable Breast Cancer
Enrollment 276 participants
Start Date 2026-06
Primary Completion 2027-06 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2026-05-18