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

NCT06970561 | Completed

• 1 other identifier: 2020091
• Study Type: observational
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer Surgery; Benign Breast Tumors

Keywords

intraductal papilloma of the breast; treatment; vacuum-assisted rotational excision therapy

Outcome Measures

Primary Outcomes (1)

• recurrence

  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

  The cut-off date for follow-up was September 2024

Study Arms (2)

recurrent

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

Procedure: enlarged resection

non-recurrent

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

Interventions

enlarged resection PROCEDURE

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

Also known as: secondary enlarged resection

recurrent

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

IDP patients who underwent ultrasound-guided VAE treatment from January 2020 to August 2024 in Zhongnan Hospital of Wu han University.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Wuhan Children's Hospital: lead

Study Sites (1)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430016, China

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician，Thyroid and breast surgery

Study Record Dates

• First Submitted: May 4, 2025
• First Posted: May 14, 2025
• Study Start: January 6, 2020
• Primary Completion: August 1, 2024
• Study Completion: September 1, 2024
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: starting 6 months after publication
• Access Criteria: The IPD can be shared for the summary report of test results,the reanalysis of test data and enables the combination of test data with other data for new research.

Locations

CN (1)