Breast Lump Clipping Methods Comparison

NCT07716644 | Active Not Recruiting

• 1 other identifier: Faiqa/TUF/EIRB/176/26
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Breast cancer is the most frequently diagnosed malignancy among women worldwide, with increasing rates in later life. It represents a significant healthcare challenge in low- and middle-income countries where limited access to diagnostic imaging and specialised breast services contributes to delays in diagnosis and suboptimal treatment outcomes. Accurate localisation of breast lesions is fundamental for effective breast cancer management, particularly in patients undergoing neoadjuvant chemotherapy where the primary tumour may become clinically or radiologically occult. Breast lesion clips serve as durable markers that allow precise localization for surgical excision and radiological follow-up. This study is a prospective comparative trial being conducted at MTH Faisalabad, Pakistan, to evaluate the efficacy and cost-effectiveness of ultrasound-guided clipping versus blind clipping of breast lesions in low socioeconomic settings. A total of 50 female patients aged 25-75 years with palpable, unifocal breast tumours (T1-T4) planned for neoadjuvant chemotherapy will be randomly assigned to one of two intervention groups using computer-generated randomization. Group A will receive blind clip placement using palpation without real-time imaging guidance. Immediate confirmation will be done by ultrasonography. Group B will receive ultrasound-guided clip placement. The primary outcome measures are the accuracy of clip placement defined as," clip localization within 10 millimeters of the target lesion on imaging", The total cost of the procedure, and safety outcomes including minor complications. Secondary outcomes include patient satisfaction measured using LIKERT score and the total number of hospital visits required. The study aims to provide evidence on whether blind clipping represents a viable, cost-effective alternative to ultrasound-guided clipping in resource-constrained environments where affordability and availability of trained radiologist present significant barriers to optimal breast cancer care.

Conditions

Breast Neoplasms

Keywords

Low socioeconomic setting; Breast lump; Clipping; Comparative study; Ultrasound guided; Blind clipping

Outcome Measures

Primary Outcomes (3)

• Efficacy of Clip Placement

  Efficacy is defined as the clip being localized in the centre of the tumour or within 10 millimetres of the target lesion on follow-up imaging. The accuracy of clip placement will be assessed by comparing the position of the clip on follow-up imaging (ultrasound or mammography) with the original tumour location as documented on pre-procedure imaging. The distance between the clip and the tumour centre will be measured in millimetres using standardized measurement techniques. Clips localized within the tumour centre or within 10 millimetres of the target lesion will be considered efficacious.

  At follow-up imaging performed 2-4 weeks after the clipping procedure

• Cost of Clipping

  The total cost of the clipping procedure calculated in Pakistani Rupees (PKR) including materials (clip device, introducer needle, sterile supplies), imaging services (ultrasound or mammography, if applicable), and personnel time (clinician time, nursing time, support staff time). The cost will be calculated from a healthcare provider perspective. For the ultrasound-guided arm, costs will include the ultrasound machine usage, sonographer time, and radiologist interpretation. For the blind clipping arm, costs will include the reduced imaging requirements. All costs will be recorded prospectively using standardized cost collection forms.

  At the time of the procedure and at the time of discharge

• Safety of the Procedure

  Safety will be assessed by monitoring for minor complications including transient pain at the clip insertion site, small haematomas, infection, clip migration, and any other adverse events. All adverse events will be recorded prospectively using standardized case report forms. Pain will be assessed using a visual analogue scale from 0 (no pain) to 10 (worst possible pain) at the time of the procedure and at follow-up. Haematoma size will be measured using ultrasound if clinically significant. Participants will be followed for any complications throughout the study period. All adverse events will be graded using a standardized severity scale (mild, moderate, severe).

  From the time of procedure through the completion of follow-up at 4 weeks post-procedure

Secondary Outcomes (2)

• Patient Satisfaction

  At the time of follow-up imaging performed 2-4 weeks after the clipping procedure

• Number of Hospital Visits

  From the date of enrollment through the completion of follow-up at 4 weeks post-procedure

Study Arms (2)

Blind Clip Placement

EXPERIMENTAL

Participants assigned to this arm will undergo clip placement performed using palpation and anatomical landmarks without the use of real-time imaging guidance. The clinician will have access to the patient's ultrasound and mammography reports prior to the procedure to assess tumour location. The clip will be deployed using an introducer needle guided by tactile feedback and surface markings. No immediate post-procedure imaging confirmation will be obtained.

Procedure: Breast Lesion Clip Placement

Image-Guided Clip Placement

ACTIVE COMPARATOR

Participants assigned to this arm will undergo clip placement performed under real-time ultrasound guidance with immediate confirmation of clip position. A trained radiologist or breast surgeon will use a sterile ultrasound probe to visualize the lesion continuously throughout the procedure. The introducer needle will be guided under direct visualization, and clip position will be confirmed with post-procedure imaging before the patient leaves the procedure room.

Procedure: Breast Lesion Clip Placement

Interventions

Breast Lesion Clip Placement PROCEDURE

The procedure involves placing a small, permanent clip marker into a breast lesion to localize it for surgical excision and radiological follow-up. In the ultrasound-guided arm, a radiologist or breast surgeon will use a sterile ultrasound probe to visualize the lesion and will deploy the clip using a specialized introducer needle. In the blind clipping arm, the clinician will rely on the palpable nature of the tumor and anatomical landmarks to guide the introducer needle and deploy the clip. The procedure takes approximately 15-30 minutes to complete, and patients are monitored for a short period afterwards for any immediate complications.

Blind Clip Placement; Image-Guided Clip Placement

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients aged 25-75 years
• Unifocal lesion
• Palpable T1-T4 lesion
• Planned Neoadjuvant chemotherapy (NACT) cases
• Patient consent for tumor localization or breast-conserving surgery (BCS)

You may not qualify if:

• Known bleeding disorder
• Inflammatory breast carcinoma
• Multifocal or multicentric breast disease
• Patients who do not consent for tumor localization or BCS

Sponsors & Collaborators

• University of Faisalabad: lead

Study Sites (1)

Tertiary Care Hospitals, Faisalabad, Pakistan

Faisalābad, Punjab Province, 38000, Pakistan

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Dr Saira Saleem, MBBS

  Madina Teaching Hospital Faisalabad

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participant
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PGR, Breast Surgery, MTH

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: July 21, 2026
• Study Start: April 1, 2026
• Primary Completion: June 30, 2026
• Study Completion: July 28, 2026
• Last Updated: July 21, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)