Ultrasound Guided Clipping Versus Blind Clipping in Low Socioeconomic Settings: A Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Efficacy of Clip Placement
研究概览
简要总结
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.
详细描述
This study is designed as a single-blind randomized controlled trial. Participants diagnosed with carcinoma of the breast will be recruited from the outpatient setting of MTH in Faisalabad, Pakistan. Each participant will undergo a comprehensive initial assessment, including a detailed clinical history, physical examination, and review of available imaging studies, including ultrasound and mammography reports. Following confirmation of eligibility based on the predefined inclusion and exclusion criteria, participants will be provided with detailed information about the study objectives, procedures, potential risks and benefits, and their rights as research participants. Written informed consent will be obtained from all participants prior to enrollment.
Eligible participants will be randomly assigned to one of two intervention groups using a computer-generated randomization sequence with a 1:1 allocation ratio. The randomization sequence will be generated by an independent statistician not involved in the clinical management of participants. Group allocation will be concealed in sequentially numbered, opaque, sealed envelopes that will be opened immediately before the clipping procedure.
Group A will undergo blind clip placement. In this group, the clinician will have access to the patient's ultrasound and mammography reports to assess tumor location prior to the procedure. The clip placement will be performed using palpation of the breast lesion to guide the introducer needle. The clinician will rely on tactile feedback and surface marking to position the clip.
No real-time imaging guidance will be used during the procedure. Ultrasonography will be performed to confirm clip placement after the procedure.
Group B will undergo ultrasound-guided clip placement. In this group, the clip placement will be performed under real-time ultrasound guidance by a trained radiologist or breast surgeon. The ultrasound probe will be used to visualize the lesion continuously throughout the procedure, allowing for precise positioning of the introducer needle. The clip position will be documented with post-procedure imaging.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
盲法说明
Participant
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •Known bleeding disorder
- •Inflammatory breast carcinoma
- •Multifocal or multicentric breast disease
- •Patients who do not consent for tumor localization or BCS
结局指标
主要结局
Efficacy of Clip Placement
时间窗: At follow-up imaging performed 2-4 weeks after the clipping procedure
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.
Cost of Clipping
时间窗: At the time of the procedure and at the time of discharge
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.
Safety of the Procedure
时间窗: From the time of procedure through the completion of follow-up at 4 weeks post-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).
次要结局
- 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)
研究者
Dr Faiqa Aslam
PGR, Breast Surgery, MTH
Madina Teaching Hospital Faisalabad