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

Breast Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04911101
• Other study ID #: K2019-7986
• Status: Recruiting
• Phase: N/A
• Start date: November 19, 2019
• Est. completion date: May 2024

Study information

• Verified date: March 2023
• Source: Karolinska University Hospital
• Contact: Fredrik Strand, MD PhD
• Phone: +46851770000
• Email: fredrik.strand[@]sll.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: May 2024
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Diseases

Intervention

Device:
• Excision with 7G needle
Vacuum-assisted excision using a biopsy needle with two alternative dimensions
• Excision with 10G needle
Vacuum-assisted excision using a biopsy needle with two alternative dimensions

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Stockholm

Sponsors (4)

Lead Sponsor	Collaborator
Karolinska University Hospital	Capio Sankt Görans Hospital, Stockholm South General Hospital, Uppsala University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Excision time	Time from excision start to excision stop - reported by radiologist	Baseline
Primary	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	Number of patients with bleeding despite 10 minutes compression	Bleeding despite 10 minutes compression - reported by radiologist	Baseline
Secondary	Radicality assessment fractions	Number of fractions possible to perform after the lesion has visually been removed - reported by radiologist	Baseline
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Pain assessed by NRS at baseline	Patient pain level during procedure - reported by patient in a 10-level NRS	At baseline