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Breast Lump Clipping Methods Comparison

NCT07716644 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-07-21

No results posted yet for this study

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

Interventions

PROCEDURE

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.

Sponsors & Collaborators

  • University of Faisalabad

    lead OTHER

Principal Investigators

  • Dr Saira Saleem, MBBS · Madina Teaching Hospital Faisalabad

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2026-06-30
Completion
2026-07-28

Countries

  • Pakistan

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07716644 on ClinicalTrials.gov