Duct Ectasia BreastMDENCT04744766
Central Mammary Duct Excision; How to Improve the Outcome?
A study testing major duct excision in people with Duct Ectasia Breast and Benign Breast Disease, run by Alexandria University at 1 site in Egypt.
Trial summary
the study compares two surgical techniques in excision of the central duct system of the breast. known also as major duct excision Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Duct Ectasia Breast, Benign Breast Disease
- What is being tested?
- major duct excision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2018to 27 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- females with nipple discharge / recurrent peri-ductal mastitis
- -
Who cannot join
- suspicion or evidence of malignancy
Trial locations and contacts
1 site in 1 country.
About this study
the study compares two surgical techniques in excision of the central duct system of the breast. known also as major duct excision
Read the detailed description
first technique used is the original Hadfield techniques. the other technique is Almasad technique published in 1999. in this technique, de-epithelialization of a supraareolar area of nearly 2cm is done and elevation of the nipple areola complex is done to support the retroareolar area.
- Conditions
- Duct Ectasia Breast, Benign Breast Disease
- Being tested
- major duct excision
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
major duct excisionProcedure or surgery
2 methods of major/central mammary duct excision are compared as regard the outcome
| Study group | Role | What they receive |
|---|---|---|
| Hadfield technique group | Active comparator | central/mammary duct excision is done by the ordinary method described by Hadfield Receives: Procedure: major duct excision |
| Al Masad technique group | Active comparator | same procedure with de-epithelization of the upper pararaeolar area Receives: Procedure: major duct excision |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient satisfaction and sensation of nipple areolar complex complications
cosmetic outcome assessed via score between non-satisfied -extremely satisfied sensation is assessed via acotton bad comaring both side or nearby skin
Measured: 6 months
Secondary outcomes (1)
complications
eg nipple areolae complex (NAC) sensation, necrosis...etc
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start1 Jan 2018
- Primary completion31 Dec 2020
- Study completion27 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Duct Ectasia BreastStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mahmoud A. Alhussini, MD, Principal investigator, Faculty of Medicine , Univeristy of Alexandria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04744766
- Sponsor's protocol ID
- malhussini002
- Acronym
- MDE
- Status last verified
- Jan 2021
- First submitted
- 4 Feb 2021
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central Mammary Duct Excision; How to Improve the Outcome?
- ClinicalTrials.gov ID
- NCT04744766
- Acronym / sponsor ID
- MDE / malhussini002
- Conditions
- Duct Ectasia Breast, Benign Breast Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 27 Jan 2021 (actual)
- First posted
- 9 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
the study compares two surgical techniques in excision of the central duct system of the breast. known also as major duct excision
Detailed description
first technique used is the original Hadfield techniques. the other technique is Almasad technique published in 1999. in this technique, de-epithelialization of a supraareolar area of nearly 2cm is done and elevation of the nipple areola complex is done to support the retroareolar area.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hadfield technique group | Active comparator | Procedure: major duct excisioncentral/mammary duct excision is done by the ordinary method described by Hadfield |
| Al Masad technique group | Active comparator | Procedure: major duct excisionsame procedure with de-epithelization of the upper pararaeolar area |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- females with nipple discharge / recurrent peri-ductal mastitis
- -
Key exclusion criteria (1 listed)
- suspicion or evidence of malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| major duct excision2 methods of major/central mammary duct excision are compared as regard the outcome | Procedure or surgery | Al Masad technique group, Hadfield technique group |
Primary outcome
patient satisfaction and sensation of nipple areolar complex complications
Time frame: 6 months
cosmetic outcome assessed via score between non-satisfied -extremely satisfied sensation is assessed via acotton bad comaring both side or nearby skin
1 secondary outcome
complications
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahmoud A. Alhussini, MD principal investigator
Faculty of Medicine , Univeristy of Alexandria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing major duct excision in people with Duct Ectasia Breast and Benign Breast Disease, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patient satisfaction and sensation of nipple areolar complex complications (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2021.