Evidence map›Paper›PMID 37606837›Full record

Observational studyAnnals of surgical oncology2023

Intraoperative Ultrasound-Guided Conserving Surgery for Breast Cancer: No More Time for Blind Surgery.

Massimo Ferrucci, Francesco Milardi, Daniele Passeri, Luaya Fabrizio Mpungu, Andrea Francavilla, Matteo Cagol, Tania Saibene, Silvia Michieletto, Mariacristina Toffanin, Paola Del Bianco and 2 more

Registry-linked trialAbstract readObservational Study
In one paragraph

Observational study in Annals of surgical oncology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07185568 (IntraOperative UltraSound Guided Versus Wire Guided Versus Magnetic Seed Guided Breast-conserving Surgery for Non-palpable Tumors.The MANOLA Study Multi-center, Randomized, Open-label Clinical Trial), which is not on this map. Cited by 15 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT07185568 nanot yet recruitingnot on this mapstarted 2026, after this paper: background citation

IntraOperative UltraSound Guided Versus Wire Guided Versus Magnetic Seed Guided Breast-conserving Surgery for Non-palpable Tumors.The MANOLA Study Multi-center, Randomized, Open-label Clinical Trial

TypeinterventionalSponsorIstituto Oncologico Veneto IRCCSRan2026 to 2027Enrolled1,302ConditionsBreast Cancer, Breast-Conserving SurgeryArmsIOUS HydroMark™, Magnetic Sirius Pintuition Seed®, Wire localization (WL)
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors.

Massimo FerrucciBreast Surgery Unit, Veneto Institute of Oncology IOV, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Padua, Italy. massimoferrucci@gmail.com.
Francesco MilardiGeneral Surgery, Department of Surgery, Oncology and Gastroenterology, University of Padua, Padua, Italy.
Daniele PasseriGeneral Surgery, Department of Surgery, Oncology and Gastroenterology, University of Padua, Padua, Italy.
Luaya Fabrizio MpunguBreast Surgery Unit, Department of Surgery, Villa Salus Hospital, Venice, Italy.
Andrea FrancavillaUnit of Biostatistics, Epidemiology and Public Health, Department of CardiacThoracic Vascular Sciences and Public Health, University of Padua, Padua, Italy.
Matteo CagolBreast Surgery Unit, Veneto Institute of Oncology IOV, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Padua, Italy.
Tania SaibeneBreast Surgery Unit, Veneto Institute of Oncology IOV, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Padua, Italy.
Silvia MichielettoBreast Surgery Unit, Veneto Institute of Oncology IOV, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Padua, Italy.
Mariacristina ToffaninBreast Surgery Unit, Veneto Institute of Oncology IOV, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Padua, Italy.
Paola Del BiancoClinical Trials and Biostatistics, Veneto Institute of Oncology IOV, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Padua, Italy.
Ugo GrossiGeneral Surgery, Department of Surgery, Oncology and Gastroenterology, University of Padua, Padua, Italy.
Alberto MarchetBreast Surgery Unit, Veneto Institute of Oncology IOV, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Padua, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBreast-conserving surgery (BCS) still remains a blind surgery despite all available tumor localization methods. Intraoperative ultrasound (IOUS) allows real-time visualization during all resection phases.

methodsThis was a prospective observational cohort study conducted at the Veneto Institute of Oncology between January 2021 and June 2022. Patients with ductal carcinoma in situ, T1-2 invasive cancer, or post-neoadjuvant tumors, suitable for BCS, were recruited. All breast cancer lesion types were included, i.e. solid palpable, solid non-palpable, non-solid non-palpable, and post-neoadjuvant treatment residual lesions. Eligible participants were randomly assigned to either IOUS or traditional surgery (TS) in a 1:1 ratio. The main outcomes were surgical margin involvement, reoperation rate, closest margin width, main specimen and cavity shaving margin volumes, excess healthy tissue removal, and calculated resection ratio (CRR).

resultsOverall, 160 patients were enrolled: 80 patients were allocated to the TS group and 80 to the IOUS group. IOUS significantly reduced specimen volumes (16.8 cm

conclusionsIOUS allows real-time resection margin visualization and continuous control during BCS. It showed clear superiority over TS in both oncological and surgical outcomes for all breast cancer lesion types. These results disfavor the paradigm of blind breast surgery.

Indexed as

Breast NeoplasmsUltrasonic Surgical ProceduresFemaleHumansMargins of ExcisionProspective StudiesUltrasonography, Interventional

Identifiers

PMID37606837
PMCPMC13086750

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.