Breast Lump Clipping Methods Comparison

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.

Measures will be taken to ensure blinding and minimize bias. Participants will be blinded to their group assignment. The nature of the procedure may make complete blinding challenging for the clinicians performing the procedure.

The intervention will be performed over a defined period within routine clinical practice. Both groups will receive standard baseline care to ensure consistency. The protocol has been designed to be feasible within routine clinical practice and reproducible in similar healthcare settings with limited resources.

Outcome assessments will be conducted after the procedure. The primary efficacy outcome will be assessed after the procedure in the ultrasound room, with pre-planned collaboration with a sonologist. The cost of the clipping procedure will be calculated based on the materials used, imaging services utilized, and personnel time. Safety outcomes will be monitored throughout the study period and documented at each clinical encounter.

Patient satisfaction will be measured using a Likert scale administered through a structured questionnaire at the time of follow-up. Participants will be asked to rate their satisfaction with various aspects of the clipping procedure, including comfort, information provided, and overall experience. The number of hospital visits will be recorded for each participant from the date of enrollment through the completion of the procedure.

Statistical analysis will be performed using SPSS version 27 statistical software. Data distribution will be assessed for normality using the Shapiro-Wilk test. Normally distributed continuous variables will be presented as means with standard deviations and compared between groups using the independent-samples t-test. Non-normally distributed variables will be presented as medians with interquartile ranges and compared using the Mann-Whitney U test. Categorical variables will be presented as frequencies and percentages and compared using the chi-square test or Fisher's exact test, as appropriate. Within-group changes over time will be evaluated using the paired t-test or Wilcoxon signed-rank test, as appropriate. A threshold for statistical significance will be established at p < 0.05.

All analyses will be performed on an intention-to-treat basis. A per-protocol analysis will also be conducted as a sensitivity analysis. Missing data will be handled using appropriate imputation methods. The results of this study will be reported in accordance with the Consolidated Standards of Reporting Trials guidelines.

This study aims to contribute to the existing body of evidence by providing controlled clinical data on the role of blind clipping in low socioeconomic settings. Furthermore, the study may serve as a basis for future research exploring optimized protocols in larger multicenter trials, potentially leading to improved breast cancer outcomes in resource-limited settings through more accessible and cost-effective localization techniques.

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