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Granulomatous MastitisNCT03724903

Ductal Lavage Versus Corticosteroids Therapy for Idiopathic Granulomatous Mastitis

A study testing Ductal lavage and Corticosteroid therapy in people with Granulomatous Mastitis, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A single-arm, proof-of-concept trial has shown the safety and efficacy of ductal lavage as a treatment for idiopathic granulomatous mastitis patients (Manuscript accepted in Journal of Surgical Research 2018). Read more about this study

Who is it for?
Ages 18 to 65 years, women only
Conditions the study is for
Granulomatous Mastitis
What is being tested?
Ductal lavage and Corticosteroid therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
2 sitesChina
Study dates
1 Apr 2019to 21 Apr 2023
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 18 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female, age between 18 and 65 years old.
  • Inform consent signed.
  • Clinical diagnosis of non-lactating mastitis, defined as mastitis occurred more than 1 month after the cessation of lactation.
  • Clinical and pathological diagnosis of idiopathic granulomatous mastitis.
  • Never receive surgical treatments, or corticosteroids therapy after the cessation of lactation. Core needle biopsy is allowed.
  • Good health, judged by clinicians, to receive ductal lavage.
  • M score >=2

Who cannot join

  • Grade III inverted nipple(Plastic. Reconstruction. Surgery. 104: 389, 1999.)
  • Lactational mastitis patients.
  • Bilateral IGM patients.
  • Clinically diagnosis of periductal mastitis.
  • Pathological diagnosis of breast carcinoma.
  • Pregnant women.
Show all 14Show fewer
  • Evidences suggest possible diagnosis of SLE(systemic lupus erythematosus), rheumatic disorders or other systematic auto-immune diseases.
  • Evidences suggest possible diagnosis of tuberculosis.
  • Evidences suggest possible diagnosis of fungus infection of the breast
  • History of breast trauma.
  • History of taking oral corticosteroids or anti-tuberculosis treatment.
  • Imaging examinations indicates foreign objects retained in the breast
  • Presence of sepsis or severe inflammation caused by IGM, for which surgery is likely required.
  • Patients with inappropriate coagulation function, cardiac function, pulmonary function, liver and renal function, that clinicians judges as not suitable to participate in this study.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Jiangmen Maternal and Child Health Care Population ＆ Family Planning Service Center

    Jiangmen, Guangdong, 510000

  • Lian Jiang People'S Hospital

    Lianjiang, Guangdong, 524400

Other trials in China

About this study

Official title: Ductal Lavage Versus Corticosteroids Therapy for Idiopathic Granulomatous Mastitis: a Multicenter, Randomized, Open-labelled, Non-inferior Trial.

A single-arm, proof-of-concept trial has shown the safety and efficacy of ductal lavage as a treatment for idiopathic granulomatous mastitis patients (Manuscript accepted in Journal of Surgical Research 2018). In this multicenter, randomized, open-labeled, non-inferior trial, the investigators are going to enroll eligible granulomatous mastitis patients and randomized them into ductal lavage versus. corticosteroids therapy group. The primary endpoint of this study is the complete clinical response rate at 1 year after the enrollment. The aim of this study is to provide evidence for the management of idiopathic granulomatous mastitis patients .

Read the detailed description

Non-lactational mastitis (NLM) consists of a broad spectrum of inflammatory breast diseases. Among them, periductal mastitis and idiopathic granulomatous mastitis(IGM) are the most commonly encountered in clinical practice. IGM can be diagnosed when all possible causes of granulomatous diseases (known mycobacterial or fungal infection, Wegener granulomatosis, sarcoidosis, etc.) are excluded. There is no consensus on the standard treatment of IGM patients. Surgery, oral corticosteroids, topical steroids, immunosuppressive therapy, and observation alone were all proposed as the treatment for IGM patients. However, all of the evidences are derived from retrospective studies. In a previous study, the investigators conducted a single-arm, proof-of-concept trial that showed the safety and efficacy of ductal lavage as a treatment for IGM patients. Ductal lavage is possible to spare the patients from corticosteroids therapy and or surgery. To further address this issue, the investigators are going to conduct this multicenter, randomized, open-labeled, non-inferior trial, to compare the efficacy and safety of ductal lavage and corticosteroids therapy. The aim of this study is to provide evidence for the management of IGM patients.

Being tested
Ductal lavage, Corticosteroid therapy
Medical subject headings
Granulomatous Mastitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ductal lavageProcedure or surgery

    The patients received ductal lavage and breast massage every other day for two weeks. We used lidocaine (1%) for local anesthesia around the nipple. We used a lacrimal probe to identify 4-5 openings in the lactiferous ducts on the nipple and inserted the infusion cannula (21-23G). A total of 25ml of irrigation solution (5 ml of 2% lidocaine, 40 mg of triamcinolone acetonide, 20 ml of 0.9% saline and 1.0 g of ceftriaxone) was pumped into the ducts over 20-25 minutes. The patient returned to the clinic the next day for breast massage, and the cycle was repeated for two weeks.

  • Corticosteroid therapyDrug

    Methylprednisolone(Common brand names: Medrol) or prednisone 20-40mg, qd for two weeks, then temper the dose gradually, and then 20mg qd for maintenance (The total duration of the treatment is 6 months).

Study groups in NCT03724903
Study groupRoleWhat they receive
Ductal lavageExperimentalDuctal lavage and breast massage for two weeks.
Receives: Procedure: Ductal lavage
Corticosteroids therapyActive comparatorOral corticosteroids therapy for 6 months.
Receives: Drug: Corticosteroid therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complete Clinical Response(cCR)

    The proportion of patients that achieve M-score <=1 at 1 year after the treatment.

    Measured: 1 year since randomization

Secondary outcomes (5)

  1. Time to cCR

    The median time to cCR since the randomization.

    Measured: 1 year since randomization

  2. Treatment failure (TF) rate

    The proportion of patients with TF at 1 year since the randomization. The TF status is defined as the following:

    1. If the patient has M-score>=6 before randomization, TF is defined as the M-score still remains >=6 at one month since the randomization.
    2. If the patient has M-score between 4 and 5 before randomization, TF is defined as the M-score still remains at >=4, and never have been lower than 4.
    3. If the patient has M-score<4 before randomization, and never reaches cCR since randomization, and during follow-up, the M-score is found to be >5 and last for one month.

    Measured: 1 year since randomization

  3. Relapse rate

    The proportion of patients that had M-score>4 among those patients who achieved cCR.

    Measured: 1 year since randomization

  4. Adverse events

    Pre-defined and any other unexpected adverse events would be recorded and compared between the two arms.

    Measured: 1 year since randomization

  5. Protocol compliance rate

    The proportion of patients who received the treatment protocol.

    Measured: 1 year since randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2018
  2. Study start1 Apr 2019
  3. Primary completion21 Apr 2023
  4. Study completion21 Apr 2023

Resources

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
None (open label)
Enrolment
140 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03724903
Sponsor's protocol ID
Ductal-2018-Jun-14
Status last verified
Jan 2024
First submitted
28 Oct 2018
Last updated
30 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The study protocol and the raw and clean data for analysis will be shared among the participated researchers. Non-researchers could obtain relevant informations from the researchers upon reasonable requests.

Publications

  • Hu T, Li S, Huang H, Huang H, Tan L, Chen Y, Deng H, Wu J, Zhu L, Zhang J, Su F, Chen K. Multicentre, randomised, open-label, non-inferiority trial comparing the effectiveness and safety of ductal lavage versus oral corticosteroids for idiopathic granulomatous mastitis: a study protocol. BMJ Open. 2020 Oct 10;10(10):e036643. doi: 10.1136/bmjopen-2019-036643.

    PubMed 33039992

  • Chen K, Zhu L, Hu T, Tan C, Zhang J, Zeng M, Li S, Song E. Ductal Lavage for Patients With Nonlactational Mastitis: A Single-Arm, Proof-of-Concept Trial. J Surg Res. 2019 Mar;235:440-446. doi: 10.1016/j.jss.2018.10.023. Epub 2018 Nov 19.

    PubMed 30691827

  • Chen X, Huang H, Huang H, Yong J, Zhu L, Chen Q, Tan L, Zeng Y, Yang Y, Zhao J, Rao N, Ding L, Wu W, Li Y, Gui X, Ye L, Xu Y, Jiang Y, Su L, Xiao Q, Cai X, Hu T, Tan C, Liu Q, Liu S, Zhao J, Wang Y, Yu F, Zhang J, Li S, Chen K. Ductal lavage followed by observation versus oral corticosteroids in idiopathic granulomatous mastitis: A randomized trial. Nat Commun. 2024 Oct 23;15(1):9144. doi: 10.1038/s41467-024-53143-2.

    PubMed 39443446

Questions about this trial

What is this clinical trial studying?

A study testing Ductal lavage and Corticosteroid therapy in people with Granulomatous Mastitis, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 2 sites in China.

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 7 inclusion and 14 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 30 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. 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?

Complete Clinical Response(cCR) (time frame: 1 year since randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03724903, which also lists 3 linked publications.

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 30 Oct 2024.

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