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

May 11, 2026 updated by: Rosa Di Micco, MD, IRCCS San Raffaele

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

276

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Data from breast cancer patients who completed pre-pectoral implant-based breast reconstruction, both DTI and TE-I, between January 2022 and December 2024, will be retrospectively extracted from electronic medical records and institutional databases.

Description

Inclusion Criteria:

  • Female patients ≥18 years
  • Patients undergoing unilateral or bilateral therapeutic mastectomy for breast cancer

  • Patients undergoing pre-pectoral implant-based breast reconstruction, either:

    • One-stage DTI, or
    • Two-stage TE-I
  • Use of implant with or without biological or synthetic mesh
  • Contralateral prophylactic mastectomy allowed if a therapeutic mastectomy was performed on one side

Exclusion Criteria:

  • Male patients
  • Subpectoral implant-based reconstruction
  • Autologous breast reconstruction
  • Delayed reconstructions not performed at the time of mastectomy
  • Incomplete clinical or follow-up data for primary endpoint analysis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
One-stage DTI
Patients who underwent one-stage direct-to-implant pre-pectoral reconstructive strategy
Two-stage TE-I
Patients who underwent two-stage expander-implant pre-pectoral reconstructive strategy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary objective
Time Frame: 3 months post-surgery
To evaluate the rate of implant loss within 3 months per patient
3 months post-surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary objectives
Time Frame: 3, 12, 24 months post-surgery
To evalueate early and late-onset postoperative complications and to revaluate re-admission and re-operation rates
3, 12, 24 months post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Raffaele

Collaborators

Regional Hospital Lugano (EOC), Switzerland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

May 11, 2026

First Submitted That Met QC Criteria

May 11, 2026

First Posted (Actual)

May 18, 2026

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EXPRESSO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe