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Completed

NCT Number: NCT06970561

Analysis of Recurrence of Intraductal Papilloma Treated With Vacuum-assisted Rotary Excision

To study the postoperative recurrence of intraductal papillomas (IDP) treated with ultrasound-guided vacuum-assisted excision (VAE), and to investigate the effect of different lesion characteristics on recurrence.

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Key information

Conditions

Breast Cancer Surgery Benign Breast Tumors

Sex eligibility

Female

Study type

Observational

Primary location

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430016, China

About this study

106 patients with IDP with or without atypical ductal hyperplasia (ADH) treated with ultrasound-guided VAE at Zhongnan Hospital of Wuhan University from January 2020 to August 2024 were selected for the study, and the postoperative conditions of the patients were sorted out and followed up to analyze the characteristics of the lesions and to determine the relevant factors that affected the postoperative recurrence.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • IDP was diagnosed pathologically after VAE treatment
  • the tumor was a solitary lesion with the margin >1cm from the nipple and the longest diameter of the tumor <3cm
  • it was not associated with other breast diseases

Exclusion criteria

  • previous ductal breast surgery
  • abnormal coagulation function or taking anticoagulant drugs .recent or current use of hormonal or psychotropic drugs.

Treatment and study plan

enlarged resection

Procedure

patients underwent secondary enlarged resection within 1 month after the diagnosis of IDP combined with ADH,

Other names: secondary enlarged resection

Primary outcomes

  1. recurrence

    Time frame: The cut-off date for follow-up was September 2024

    Recurrence was defined as the appearance of a lesion within 2-3 cm of the original surgical area with corresponding clinical manifestations, such as nipple discharge and imaging support, which was later pathologically confirmed as IDP

Sponsors and collaborators

Lead sponsor

Wuhan Children's Hospital

Other

Registry information

Official study title

Analysis of Factors Associated With Postoperative Recurrence of Intraductal Papilloma of the Breast Treated With Ultrasound-guided Vacuum-assisted Rotary Excision

Acronym: IDP

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
May 14, 2025
Registry last updated
May 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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