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RECRUITING
NCT07894614

Ablation Versus Non-ablation Strategies for Non-puerperal Mastitis: A Prospective Real-world Registry Study

Sponsor: Song Hongping

View on ClinicalTrials.gov

Summary

The goal of this prospective registry cohort study is to evaluate the efficacy and quality-of-life impact of ablation therapy in patients with non-puerperal mastitis. The main questions it aims to answer are: Does ablation therapy effectively control inflammation in patients with non-puerperal mastitis? Does ablation therapy lead to a superior quality of life compared to standard treatments? Researchers will compare patients receiving ablation therapy to those receiving oral medication or surgery to see if ablation provides better inflammatory control and improves patients' quality of life. Participants will undergo their assigned treatment (ablation, oral medication, or surgery) and be asked to complete regular follow-up visits and quality-of-life questionnaires over a long-term period.

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

340

Start Date

2026-01-01

Completion Date

2030-12-01

Last Updated

2026-10-26

Healthy Volunteers

No

Interventions

PROCEDURE

Ablation

Under real-time ultrasound guidance, an ablation needle (radiofrequency electrode, microwave antenna, or laser fiber) is precisely punctured into the center of the lesion. The corresponding energy generator is then connected with parameters configured, and energy delivery is initiated to rapidly raise local tissue temperature above 60 °C, inducing coagulative necrosis of cells via thermal biological effects. The ablation zone is continuously monitored by imaging during the procedure; needle position or parameters are adjusted when necessary to ensure complete lesion coverage. Energy output is terminated once the pre-set ablation margin is achieved, and the ablation needle is withdrawn.

OTHER

Observation

Basic symptomatic treatment: Patients receive symptomatic care. Glucocorticoid therapy: Prednisone (5 mg), methylprednisolone (4 mg) or prednisone acetate (5 mg) starts at 0.5 mg/(kg·d). After 2-week maintenance, doses are gradually tapered; low-dose maintenance (2.5-5.0 mg/d) continues 4-8 weeks per symptoms and tolerability. Anti-tuberculosis therapy: Oral rifampicin, isoniazid and ethambutol for 6-9 months. Surgical resection: Pre-operative ultrasound maps lesions. Local or general anesthesia is used. Inflammatory lesions and sinus tracts are completely excised with maximal preservation of normal breast parenchyma.Intra-operative hemostasis and saline irrigation are done; primary closure or open drainage depends on wound status. Post-operative symptomatic care and wound dressing are provided.

Locations (1)

First Affiliated Hospital of Air Force Medical University

Xi'an, Shannxi, China