Clinical trial · Interventional
Breast Lump Clipping Methods Comparison
Ultrasound Guided Clipping Versus Blind Clipping in Low Socioeconomic Settings: A Comparative Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Breast Lesion Clip Placement | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Blind Clip Placement
- description
- 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.
- interventionNames
- Procedure: Breast Lesion Clip Placement
- type
- ACTIVE_COMPARATOR
- label
- Image-Guided Clip Placement
- description
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 25 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 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) Exclusion Criteria: * Known bleeding disorder * Inflammatory breast carcinoma * Multifocal or multicentric breast disease * Patients who do not consent for tumor localization or BCS
References
Publications (0)
Data not yet available