Microdochectomy for Chronic Non Dilated Single Duct Nipple Discharge

December 12, 2025 updated by: Reham Zakaria Mohamed Ahmed, Zagazig University

Ultrasound Guided Microdochectomy in Chronic Non Dilated Single Duct Nipple Discharge

The goal of this clinical trial is to evaluate the efficacy of a new technique in treatment of single milk duct discharge. The main questions it aims to answer are:

Does ultrasound guided microdochectomy is feasible in non dilated milk duct? What are the surgical outcomes of this technique?

Participants will:

Had ultrasound microdochectomy After discharge, patients will visit the clinic twice every week for two weeks, a visit or call after 3 month

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Zagazig
      • Zagazig, Zagazig, Egypt, 44519
        • Faculty of Medicine, Zagazig University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • females above 18 years old with single not dilated milk duct discharge after failure of medical treatment

Exclusion Criteria:

  • breast cancer
  • patients with multiple or dilated milk duct discharge.
  • contraindications to surgery or ‬anaesthesia
  • patient above 18 years old
  • patients refuse to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: patients with single milk duct discharge
Procedure: ultrasound guided microdochectomy
ultrasound was used to perform microdochectomy for single not dilated milk duct without cannulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nipple discharge
Time Frame: from first day after surgery to 3 months after surgery
stop of spontaneous and induced nipple discharge by absence of stain on dressing and clothes and by squeezing the nipple
from first day after surgery to 3 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
operation time
Time Frame: from skin incision to closure
operation time is calculated in minutes
from skin incision to closure
Bleeding
Time Frame: from skin incision to skin closure
Bleeding is evaluated in mm using gravimetric and direct vision methods
from skin incision to skin closure
post operative pain
Time Frame: from the day of surgery to one week after surgery
post operative pain is assessed using the visual analogue scale. The total score is out of 10 (1 means painless, 10 means painful)
from the day of surgery to one week after surgery
hospital stay
Time Frame: from the first day of surgery to 3 days after surgery
hospital stay is recorded in days
from the first day of surgery to 3 days after surgery
wound infection
Time Frame: from one day to 2 weeks after surgery
wound infection diagnosed by direct vision of pus or ultrasound of the breast
from one day to 2 weeks after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zagazig University

Investigators

  • Principal Investigator: Reham Zakaria, M.D, Faculty of Medicine, Zagazig University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 27, 2025

Primary Completion (Estimated)

April 27, 2026

Study Completion (Estimated)

April 27, 2026

Study Registration Dates

First Submitted

December 12, 2025

First Submitted That Met QC Criteria

December 12, 2025

First Posted (Actual)

December 26, 2025

Study Record Updates

Last Update Posted (Actual)

December 26, 2025

Last Update Submitted That Met QC Criteria

December 12, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1248\27-4-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

data will be available on demand by direct contact to the principle investigator

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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