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

NCT ID: NCT06970561

Last Updated: 2025-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

106 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-06

Study Completion Date

2024-09-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Breast Cancer Surgery Benign Breast Tumors

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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recurrent

Patients who relapsed after receiving ultrasound-guided vacuum-assisted rotary excision

enlarged resection

Intervention Type PROCEDURE

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

non-recurrent

Patients who did not relapsed after receiving ultrasound-guided vacuum-assisted rotary excision

No interventions assigned to this group

Interventions

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enlarged resection

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

Intervention Type PROCEDURE

Other Intervention Names

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secondary enlarged resection

Eligibility Criteria

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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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Wuhan Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Gang Hu

Attending physician,Thyroid and breast surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

Site Status

Countries

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China

Other Identifiers

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2020091

Identifier Type: -

Identifier Source: org_study_id

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