Performance Indicators and Patient Experience in 7G and 10G Vacuum-assisted Excision of Probably Benign Breast Lesions

The purpose of this study is to assess how the needle size 7G vs 10G affects performance indicators and patient experience in vacuum-assisted excision (VAE) of probably benign breast lesions

Study Overview

• Status: Recruiting
• Conditions: Breast Diseases
• Intervention / Treatment: Device: Excision with 7G needle; Device: Excision with 10G needle

Detailed Description

After being informed about the study and potential risks, all patients giving written informed consent will have a VAE procedure to remove their breast lesion and will be randomised to either 7G or 10G needle size. After completion of the procedure, the patients fill out a questionnaire to collect data on their experience. The radiologist performing the procedure fills out a form collecting procedural performance indicators.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fredrik Strand, MD PhD; Phone Number: +46851770000; Email: fredrik.strand@sll.se
• Study Contact Backup: Name: Athanasios Zouzos, MD; Phone Number: +46851770000; Email: athanasios.zouzos@sll.se

Study Locations

• Sweden
  • Stockholm, Sweden, 17164
    • Recruiting
    • Karolinska University Hospital
    • Contact: Athanasios Zouzos, MD; Phone Number: +46851770000; Email: athanasios.zouzos@sll.se
    • Sub-Investigator: Athanasios Zouzos, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Biopsy-verified probably benign breast lesion less than 20 mm size
• Biopsy-verified benign breast lesion less than 30 mm size
• Screen-detected group of microcalcifications under 10 mm size

Exclusion Criteria:

• Age less than 18 years of age
• Inability to understand the meaning of informed consent
• Pregnancy
• Breast-feeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 7G needle; 7G needle dimension used	Device: Excision with 7G needle; Vacuum-assisted excision using a biopsy needle with two alternative dimensions
EXPERIMENTAL: 10G needle; 10G needle dimension used	Device: Excision with 10G needle; Vacuum-assisted excision using a biopsy needle with two alternative dimensions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Excision time	Time from excision start to excision stop - reported by radiologist	Baseline
Pain assessed by NRS 2 weeks after baseline	Patient pain level during the experience - reported by patient in a 10-level NRS	2 weeks after baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with bleeding despite 10 minutes compression	Bleeding despite 10 minutes compression - reported by radiologist	Baseline
Radicality assessment fractions	Number of fractions possible to perform after the lesion has visually been removed - reported by radiologist	Baseline
Self-reported number of patients who would recommend the procedure to others	Would the patient recommend the same procedure to others in same situation - reported by patient as yes or no	1 week after baseline
Self-reported satisfaction with cosmetic result assessed by a categorical scale	How dissatisfied is the patient with the cosmetic result - reported by patient - using a categorical scale from "not at all", "somewhat", "rather", "very".	1 week after baseline
Number of patients with self-reported occurrence of wound infection	Occurrence of wound infection - reported by patient as yes or no	1 week after baseline
Remaining scar	Yes = Any sign of prior trauma to the skin, No = Otherwise, Reported by radiologist as assessed by visual inspection	6 months after baseline
Pain assessed by NRS at baseline	Patient pain level during procedure - reported by patient in a 10-level NRS	At baseline

Collaborators and Investigators

• Sponsor: Karolinska University Hospital
• Collaborators: Uppsala University Hospital; Stockholm South General Hospital; Capio Sankt Görans Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 19, 2019
• Primary Completion (ANTICIPATED): November 1, 2022
• Study Completion (ANTICIPATED): April 1, 2023

Study Registration Dates

• First Submitted: May 20, 2021
• First Submitted That Met QC Criteria: May 27, 2021
• First Posted (ACTUAL): June 2, 2021

Study Record Updates

• Last Update Posted (ACTUAL): August 19, 2022
• Last Update Submitted That Met QC Criteria: August 18, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Breast; Vacuum-assisted excision; Needle size; Minimally invasive procedure
• Additional Relevant MeSH Terms: Skin Diseases; Breast Diseases
• Other Study ID Numbers: K2019-7986

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: Yes
• product manufactured in and exported from the U.S.: Yes