MastitisNCT02794688
Ductal Lavage in Non-lactating Female Women With Mastitis
An observational study of Mastitis, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
RATIONALE and PURPOSE: For non-lactational mastitis patients pathologically diagnosis of idiopathic granulomatous mastitis (IGM) or periductal mastitis (PD), the investigators hypothesized that ductal lavage is able to relieve the symptoms and achieve complete response, with shorter recovery time than oral intake of… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Mastitis
- What is being tested?
- Ductal lavage therapy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- Aug 2016to 5 Jun 2019
- Phase
- Observational
- 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
Study population: Women with non-lactating mastitis, pathologically diagnosed as idiopathic granulomatous mastitis (IGM) or periductal mastitis (PD), were included in this study.
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 year after the cessation of lactation.
- Never receive any treatments after the cessation of lactation.
- Good health, judged by clinicians, to receive ductal lavage.
- Pathologically diagnosed as idiopathic granulomatous mastitis (IGM) or periductal mastitis (PD).
Who cannot join
- Pathological diagnosis of breast carcinoma.
- Pregnant women.
- Evidences suggest possible diagnosis of systemic lupus erythematosus(SLE), rheumatic disorders or other systematic auto-immune diseases.
- Evidences suggest possible diagnosis of tuberculosis.
- Imaging examinations indicates foreign objects retained in the breast
- Evidences suggest possible diagnosis of fungus infection of the breast
- 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
1 site in 1 country.
China1 site
Sun-Yat-Sen Memorial Hospital of Sun-Yat-Sen University
Guangzhou, Guangdong, 510120
About this study
Official title: Ductal Lavage in Non-lactating Female Women With Mastitis: A Single Arm, Observational Study
RATIONALE and PURPOSE: For non-lactational mastitis patients pathologically diagnosis of idiopathic granulomatous mastitis (IGM) or periductal mastitis (PD), the investigators hypothesized that ductal lavage is able to relieve the symptoms and achieve complete response, with shorter recovery time than oral intake of antibiotics or corticosteroids treatments. This single arm, observational, case series, pilot study is going to evaluate the effectiveness of ductal lavage in patients with non-lactational IGM or PD.
Read the detailed description
Inflammatory non-lactating breasts diseases encompasses a large spectrum of diseases ranging from infective diseases to autoimmune diseases, which cause considerable morbidity and difficulty in diagnosis. In daily practices, exclusion of possible diagnosis of breast carcinoma is the most important step. Aetiological factors for non-lactational mastitis include bacterial infection, tuberculosis, auto-immune disorders, etc. Treatments for these patients including antibiotics, anti-tuberculosis therapy, and corticosteroids treatments. Many of these patients were pathologically diagnosed as periductal mastitis (PD) or idiopathic granulomatous mastitis (IGM). The current treatment for PD or IGM include corticosteroids treatments, antibiotics and surgical treatments. Based on literature review, the complete response (CR) rate of corticosteroids and surgical treatment ranged between 63-87% and 89-100%, respectively. Time to CR ranged between 2-8 month for corticosteroid treatment.
Pathological findings of patients of IGM or PD revealed infiltrating inflammatory cells and neutrophilic microabscesses around the lobular units and partial ductal obstruction, we hypothesized that ductal lavage therapy will be able to relieve the symptom by dilating the lactiferous duct followed by irrigation solution flushing, with shorter recovery time and satisfactory CR rate. In our institution(Sun Yat-sen Memorial Hospital,Guangzhou, Guangdong, P.R.China), it is our routine practice to perform ductal lavage therapy to patients with non-lactating breasts diseases, especially for patients with IGM or PD, before we start corticosteroid or antibiotics treatments. For patients with evidence of bacterial infection, antibiotics was added into the irrigation solution. In our experience, many patients had short recovery time and low relapse rate, sparing the use of corticosteroid or antibiotics treatments. However, there is no concrete data to quantify the efficacy of ductal lavage therapy for IGM or PD patients. This observational study aims to prospectively enroll eligible patients and investigate the efficacy of ducal lavage therapy in IGM or PD patients.
- Conditions
- Mastitis
- Being tested
- Ductal lavage therapy
- Keywords
- Non-lactating, idiopathic granulomatous mastitis, periductal mastitis, ductal lavage
- Medical subject headings
- Mastitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ductal lavage therapyProcedure or surgery
- Patient lies in supine position, with routine sterilizing and draping procedure.
- Local anesthesia with 2ml lidocaine (1%) around the nipple.
- Identification of 4-5 openings of the lactiferous ducts from the nipple.
- Insertion of all infusion cannula (21-23G ) into the identified openings of the lactiferous ducts.
- Start the infusion pump with 15ml irrigation solution (2% Lidocaine 5ml, Triamcinolone acetonide 40mg，0.9% saline 10ml and ceftriaxone 1.0g). If the patients had elevated white blood cell count and fever (>38 celsius degree), oral intake or infusion of antibiotics were allowed, when necessary.
- The patient returns to the clinic the next day, with the irrigation solution staying in the lactiferous ducts overnight, and receives breast massage.
- Repeat step 1-6 every other day for 2 weeks.
- Fine needle aspiration is allowed. Oral intake of corticosteroids, excisional drainage or surgery are not allowed.
| Study group | Role | What they receive |
|---|---|---|
| Ductal lavage group | The patients will receive ductal lavage therapy every other day for two weeks, and will be followed up for one year. Receives: Procedure: Ductal lavage therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to complete response
The length of time from the date of initial treatment to the date of complete response. Complete response (CR) was defined as reaching all of the followings: 1) visual analogue score <=1; 2) Disappearance of all local symptoms, such as redness, pain, swollen, etc. 3) Disappearance of fistula, if any; 4) The patient can return to normal life without any medical assistant.5) Disappearance of palpable or ultrasound detectable mass were defined as physical-CR and imaging-CR, respectively.
Measured: Time from the initial treatment to first assessment of complete response, reported between day of first treatment and 1 year thereafter.
Secondary outcomes (4)
Complete response rate
The proportion of patients with complete response within 1 year after the initial treatment.
Measured: Evaluations were performed every week for the 1st month, and every other month thereafter until complete response, reported between the day of first treatment and 1 year thereafter.
Partial response rate
The proportion of patients with partial response within 1 year after the initial treatment. Partial response was defined as reaching all of the followings: 1) decreased visual analogue score>=2; 2) Significantly relieved of all local symptoms, such as redness, pain, swollen, etc. 3) Disappearance of spontaneous discharge through fistula, if any; 4) The patient stated that the symptom is relieved significantly.5) Size of the target mass (Largest dimension) is reduced >30%, compared with that of the baseline. Partial response assessed by physical and ultrasound were defined as physical-partial-response and imaging-partial-response, respectively.
Measured: Evaluations were performed every week for the 1st month, and every other month thereafter until partial response, reported between the day of first treatment and 1 year thereafter.
Relapse incidence after complete response
The incidence of relapse after complete response, within 1 year after the initial treatment. Definition of relapse including any of the followings: 1) Notice of new palpable mass; 2) Notice of new fistula; 3) Notice of new local symptoms, such as pain, redness, swollen and heated skin. Only patients with complete response during the study follow-up will be assessed for this outcome.
Measured: Evaluations were performed every week for the 1st month, and every other month thereafter until relapse, reported between the day of complete response and 1 year after the initial treatment.
Progression incidence after partial response
The incidence of progression after partial response, within 1 year after the initial treatment. Definition of progression including any of the followings: 1) Progression of local symptoms (redness, swelling, tenderness, pain, fever) significantly. ; 2) Notice of new fistula; 3) The size of the target mass (Largest dimension) increased >20%, compared with that of the day of partial response. Only patients with partial response during the study follow-up will be assessed for this outcome.
Measured: Evaluations were performed every week for the 1st month, and every other month thereafter until disease progression, reported between the day of partial response and 1 year after the initial treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2016 (estimated)
- Study startAug 2016
- Primary completionJul 2018
- Study completion5 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for MastitisStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Guangzhou Jie Jian Instrument Co,Ltd, China Anti-aging Promoting Association
- Responsible party
- Principal investigator, Shunrong Li, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Investigators
- Shunrong Li, M.D., Principal investigator, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityErwei Song, M.D., Study director, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02794688
- Sponsor's protocol ID
- DLNLM-01
- Status last verified
- Aug 2019
- First submitted
- 24 May 2016
- Last updated
- 22 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Individual patient data (de-identified) is available upon request.
Publications
Bouton ME, Jayaram L, O'Neill PJ, Hsu CH, Komenaka IK. Management of idiopathic granulomatous mastitis with observation. Am J Surg. 2015 Aug;210(2):258-62. doi: 10.1016/j.amjsurg.2014.08.044. Epub 2015 Feb 7.
PubMed 25746911Gautier N, Lalonde L, Tran-Thanh D, El Khoury M, David J, Labelle M, Patocskai E, Trop I. Chronic granulomatous mastitis: Imaging, pathology and management. Eur J Radiol. 2013 Apr;82(4):e165-75. doi: 10.1016/j.ejrad.2012.11.010. Epub 2012 Nov 29.
PubMed 23200627Gopalakrishnan Nair C, Hiran, Jacob P, Menon RR, Misha. Inflammatory diseases of the non-lactating female breasts. Int J Surg. 2015 Jan;13:8-11. doi: 10.1016/j.ijsu.2014.11.022. Epub 2014 Nov 22.
PubMed 25447605Lacambra M, Thai TA, Lam CC, Yu AM, Pham HT, Tran PV, Law BK, Van Nguyen T, Pham DX, Tse GM. Granulomatous mastitis: the histological differentials. J Clin Pathol. 2011 May;64(5):405-11. doi: 10.1136/jcp.2011.089565. Epub 2011 Mar 8.
PubMed 21385894Chen 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
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ductal Lavage in Non-lactating Female Women With Mastitis: A Single Arm, Observational Study
- ClinicalTrials.gov ID
- NCT02794688
- Acronym / sponsor ID
- DLNLM-01
- Conditions
- Mastitis
- Keywords
- Non-lactating, idiopathic granulomatous mastitis, periductal mastitis, ductal lavage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Collaborators
- Guangzhou Jie Jian Instrument Co,Ltd, China Anti-aging Promoting Association
- Study start
- Aug 2016 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- 5 Jun 2019 (actual)
- First posted
- 9 Jun 2016 (estimated)
- 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.
RATIONALE and PURPOSE: For non-lactational mastitis patients pathologically diagnosis of idiopathic granulomatous mastitis (IGM) or periductal mastitis (PD), the investigators hypothesized that ductal lavage is able to relieve the symptoms and achieve complete response, with shorter recovery time than oral intake of antibiotics or corticosteroids treatments. This single arm, observational, case series, pilot study is going to evaluate the effectiveness of ductal lavage in patients with non-lactational IGM or PD.
Detailed description
Inflammatory non-lactating breasts diseases encompasses a large spectrum of diseases ranging from infective diseases to autoimmune diseases, which cause considerable morbidity and difficulty in diagnosis. In daily practices, exclusion of possible diagnosis of breast carcinoma is the most important step. Aetiological factors for non-lactational mastitis include bacterial infection, tuberculosis, auto-immune disorders, etc. Treatments for these patients including antibiotics, anti-tuberculosis therapy, and corticosteroids treatments. Many of these patients were pathologically diagnosed as periductal mastitis (PD) or idiopathic granulomatous mastitis (IGM). The current treatment for PD or IGM include corticosteroids treatments, antibiotics and surgical treatments. Based on literature review, the complete response (CR) rate of corticosteroids and surgical treatment ranged between 63-87% and 89-100%, respectively. Time to CR ranged between 2-8 month for corticosteroid treatment.
Pathological findings of patients of IGM or PD revealed infiltrating inflammatory cells and neutrophilic microabscesses around the lobular units and partial ductal obstruction, we hypothesized that ductal lavage therapy will be able to relieve the symptom by dilating the lactiferous duct followed by irrigation solution flushing, with shorter recovery time and satisfactory CR rate. In our institution(Sun Yat-sen Memorial Hospital,Guangzhou, Guangdong, P.R.China), it is our routine practice to perform ductal lavage therapy to patients with non-lactating breasts diseases, especially for patients with IGM or PD, before we start corticosteroid or antibiotics treatments. For patients with evidence of bacterial infection, antibiotics was added into the irrigation solution. In our experience, many patients had short recovery time and low relapse rate, sparing the use of corticosteroid or antibiotics treatments. However, there is no concrete data to quantify the efficacy of ductal lavage therapy for IGM or PD patients. This observational study aims to prospectively enroll eligible patients and investigate the efficacy of ducal lavage therapy in IGM or PD patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ductal lavage group | – | Procedure: Ductal lavage therapyThe patients will receive ductal lavage therapy every other day for two weeks, and will be followed up for one year. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with non-lactating mastitis, pathologically diagnosed as idiopathic granulomatous mastitis (IGM) or periductal mastitis (PD), were included in this study.
Key inclusion criteria (6 listed)
- Female, age between 18 and 65 years old.
- Inform consent signed.
- Clinical diagnosis of non-lactating mastitis, defined as mastitis occurred more than 1 year after the cessation of lactation.
- Never receive any treatments after the cessation of lactation.
- Good health, judged by clinicians, to receive ductal lavage.
Key exclusion criteria (7 listed)
- Pathological diagnosis of breast carcinoma.
- Pregnant women.
- Evidences suggest possible diagnosis of systemic lupus erythematosus(SLE), rheumatic disorders or other systematic auto-immune diseases.
- Evidences suggest possible diagnosis of tuberculosis.
- Imaging examinations indicates foreign objects retained in the breast
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 |
|---|---|---|
| Ductal lavage therapy1. Patient lies in supine position, with routine sterilizing and draping procedure. 2. Local anesthesia with 2ml lidocaine (1%) around the nipple. 3. Identification of 4-5 openings of the lactiferous ducts from the nipple. 4. Insertion of all infusion cannula (21-23G ) into the identified openings of the lactiferous ducts. 5. Start the infusion pump with 15ml irrigation solution (2% Lidocaine 5ml, Triamcinolone acetonide 40mg，0.9% saline 10ml and ceftriaxone 1.0g). If the patients had elevated white blood cell count and fever (>38 celsius degree), oral intake or infusion of antibiotics were allowed, when necessary. 6. The patient returns to the clinic the next day, with the irrigation solution staying in the lactiferous ducts overnight, and receives breast massage. 7. Repeat step 1-6 every other day for 2 weeks. 8. Fine needle aspiration is allowed. Oral intake of corticosteroids, excisional drainage or surgery are not allowed. | Procedure or surgery | Ductal lavage group |
Primary outcome
Time to complete response
Time frame: Time from the initial treatment to first assessment of complete response, reported between day of first treatment and 1 year thereafter.
The length of time from the date of initial treatment to the date of complete response. Complete response (CR) was defined as reaching all of the followings: 1) visual analogue score <=1; 2) Disappearance of all local symptoms, such as redness, pain, swollen, etc. 3) Disappearance of fistula, if any; 4) The patient can return to normal life without any medical assistant.5) Disappearance of palpable or ultrasound detectable mass were defined as physical-CR and imaging-CR, respectively.
4 secondary outcomes
Complete response rate
Time frame: Evaluations were performed every week for the 1st month, and every other month thereafter until complete response, reported between the day of first treatment and 1 year thereafter.
Partial response rate
Time frame: Evaluations were performed every week for the 1st month, and every other month thereafter until partial response, reported between the day of first treatment and 1 year thereafter.
Relapse incidence after complete response
Time frame: Evaluations were performed every week for the 1st month, and every other month thereafter until relapse, reported between the day of complete response and 1 year after the initial treatment.
Progression incidence after partial response
Time frame: Evaluations were performed every week for the 1st month, and every other month thereafter until disease progression, reported between the day of partial response and 1 year after the initial treatment.
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 22 Aug 2019.
- Background: PubMed 25746911Bouton ME, Jayaram L, O'Neill PJ, Hsu CH, Komenaka IK. Management of idiopathic granulomatous mastitis with observation. Am J Surg. 2015 Aug;210(2):258-62. doi: 10.1016/j.amjsurg.2014.08.044. Epub 2015 Feb 7.
- Background: PubMed 23200627Gautier N, Lalonde L, Tran-Thanh D, El Khoury M, David J, Labelle M, Patocskai E, Trop I. Chronic granulomatous mastitis: Imaging, pathology and management. Eur J Radiol. 2013 Apr;82(4):e165-75. doi: 10.1016/j.ejrad.2012.11.010. Epub 2012 Nov 29.
- Background: PubMed 25447605Gopalakrishnan Nair C, Hiran, Jacob P, Menon RR, Misha. Inflammatory diseases of the non-lactating female breasts. Int J Surg. 2015 Jan;13:8-11. doi: 10.1016/j.ijsu.2014.11.022. Epub 2014 Nov 22.
- Background: PubMed 21385894Lacambra M, Thai TA, Lam CC, Yu AM, Pham HT, Tran PV, Law BK, Van Nguyen T, Pham DX, Tse GM. Granulomatous mastitis: the histological differentials. J Clin Pathol. 2011 May;64(5):405-11. doi: 10.1136/jcp.2011.089565. Epub 2011 Mar 8.
- Derived from this study: PubMed 30691827Chen 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.
- Individual participant dataSharing planned: Yes. Individual patient data (de-identified) is available upon request.
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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.
Shunrong Li, M.D. principal investigator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Erwei Song, M.D. study director
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mastitis, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site 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 6 inclusion and 7 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 22 Aug 2019. 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 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?
Time to complete response (time frame: Time from the initial treatment to first assessment of complete response, reported between day of first treatment and 1 year thereafter.). 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 NCT02794688, which also lists 5 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 22 Aug 2019.