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Breast Lump Clipping Methods Comparison
Sponsor: University of Faisalabad
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.
Official title: Ultrasound Guided Clipping Versus Blind Clipping in Low Socioeconomic Settings: A Comparative Study
Key Details
Gender
All
Age Range
25 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2026-04-01
Completion Date
2026-07-28
Last Updated
2026-07-21
Healthy Volunteers
No
Conditions
Interventions
Breast Lesion Clip Placement
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.
Locations (1)
Tertiary Care Hospitals, Faisalabad, Pakistan
Faisalābad, Punjab Province, Pakistan