DacryocystitisNCT01772277
Efficacy of Mitomycin C in Endoscopic Dacryocystorhinostomy: A Systematic Review and Meta-Analysis
An observational study of Dacryocystitis, run by Yifan Feng at 1 site in China.
Trial summary
To assess the efficacy and safety of local application of intraoperative mitomycin C (MMC) at osteotomy site in endoscopic dacryocystorhinostomy(EN-DCR). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Dacryocystitis
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- Dec 2012to Feb 2014
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients were scheduled to undergo endoscopic dacryocystorhinostomy and randomized to with and without MMC
Who may be able to join
- comparative studies;
- adult patients (> 18 years) with NLDO undergoing primary or revision EN-DCR;
- all studies included were required to provide the success rates of both MMC and control groups, and the followed up time was more than 6 months.
Who cannot join
- studies which did not provide the success rates;
- studies which included pediatric cases.
Trial locations and contacts
1 site in 1 country.
About this study
To assess the efficacy and safety of local application of intraoperative mitomycin C (MMC) at osteotomy site in endoscopic dacryocystorhinostomy(EN-DCR).
Read the detailed description
Mitomycin C (MMC) is an antineoplastic agent that inhibits the synthesis of DNA, cellular RNA, and protein by inhibiting the synthesis of collagen by fibroblasts. MMC was originally used as a systemic chemotherapeutic agent, it has been widely used in ophthalmic practice both intraoperatively and postoperatively for prevention of pterygium recurrence, enhancing the success rate of glaucoma filtration surgery. Recently, use of MMC has been described in lacrimal drainage surgery. It is postulated that adjunctive use of MMC over the osteotomy site in endoscopic dacryocystorhinostomy(EN-DCR)surgery could inhibit scarring and granulation tissue formation around the osteotomy site or common canaliculus and enhance the success of EN-DCR surgery.
Many controlled trials have investigated adjunctive MMC for primary or revision EN-DCR to augment the surgical success rate, but the results are not completely consistent. To the best of our knowledge, there was no meta-analysis on comparison of success rate of EN-DCR with MMC (MMC group) and endoscopic dacryocystorhinostomy without MMC (control group). Therefore, the aim of this study was to undertake systematic review and meta-analysis to evaluate the efficacy of intraoperative MMC application in EN-DCR surgery and help ophthalmologists to determine whether it is a useful adjuvant in EN-DCR surgery.
- Conditions
- Dacryocystitis
- Keywords
- Endoscopic dacryocystorhinostomy, Mitomycin C
- Medical subject headings
- Dacryocystitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| MMC group | patients were scheduled to undergo Endoscopic dacryocystorhinostomy with intraoperative MMC | |
| Control group | patients were scheduled to undergo Endoscopic dacryocystorhinostomy without intraoperative MMC |
What is being measured
The primary outcome is the main question the study is designed to answer.
success rate
Success was determined by the presence of any one of the following: (1) patent lacrimal passage on syringing, (2) symptomatic improvement, and (3) endoscopic visualisation of fluorescein dye at the nasal opening of the anastomoses.
Measured: 6 months
Secondary outcomes (1)
ostium size
Change of ostium size at 3-, 6- and 12-month postoperatively
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2013 (estimated)
- Study startDec 2012
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DacryocystitisStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yifan Feng
- Sponsor type
- University, hospital or other
- Collaborators
- Wenzhou Medical University
- Responsible party
- Sponsor-investigator, Yifan Feng, Wenzhou Medical University
- Investigators
- Shiming Cheng, MD, Principal investigator, Eye Hospital, Wenzhou Medical College, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01772277
- Sponsor's protocol ID
- F20130115
- Status last verified
- Feb 2014
- First submitted
- 16 Jan 2013
- Last updated
- 13 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cheng SM, Feng YF, Xu L, Li Y, Huang JH. Efficacy of mitomycin C in endoscopic dacryocystorhinostomy: a systematic review and meta-analysis. PLoS One. 2013 May 13;8(5):e62737. doi: 10.1371/journal.pone.0062737. Print 2013.
PubMed 23675423
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Mitomycin C in Endoscopic Dacryocystorhinostomy: A Systematic Review and Meta-Analysis
- ClinicalTrials.gov ID
- NCT01772277
- Acronym / sponsor ID
- F20130115
- Conditions
- Dacryocystitis
- Keywords
- Endoscopic dacryocystorhinostomy, Mitomycin C
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Yifan FengUniversity, hospital or other
- Collaborators
- Wenzhou Medical University
- Study start
- Dec 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 21 Jan 2013 (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.
To assess the efficacy and safety of local application of intraoperative mitomycin C (MMC) at osteotomy site in endoscopic dacryocystorhinostomy(EN-DCR).
Detailed description
Mitomycin C (MMC) is an antineoplastic agent that inhibits the synthesis of DNA, cellular RNA, and protein by inhibiting the synthesis of collagen by fibroblasts. MMC was originally used as a systemic chemotherapeutic agent, it has been widely used in ophthalmic practice both intraoperatively and postoperatively for prevention of pterygium recurrence, enhancing the success rate of glaucoma filtration surgery. Recently, use of MMC has been described in lacrimal drainage surgery. It is postulated that adjunctive use of MMC over the osteotomy site in endoscopic dacryocystorhinostomy(EN-DCR)surgery could inhibit scarring and granulation tissue formation around the osteotomy site or common canaliculus and enhance the success of EN-DCR surgery.
Many controlled trials have investigated adjunctive MMC for primary or revision EN-DCR to augment the surgical success rate, but the results are not completely consistent. To the best of our knowledge, there was no meta-analysis on comparison of success rate of EN-DCR with MMC (MMC group) and endoscopic dacryocystorhinostomy without MMC (control group). Therefore, the aim of this study was to undertake systematic review and meta-analysis to evaluate the efficacy of intraoperative MMC application in EN-DCR surgery and help ophthalmologists to determine whether it is a useful adjuvant in EN-DCR surgery.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MMC group | – | –patients were scheduled to undergo Endoscopic dacryocystorhinostomy with intraoperative MMC |
| Control group | – | –patients were scheduled to undergo Endoscopic dacryocystorhinostomy without intraoperative MMC |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients were scheduled to undergo endoscopic dacryocystorhinostomy and randomized to with and without MMC
Key inclusion criteria (3 listed)
- comparative studies;
- adult patients (> 18 years) with NLDO undergoing primary or revision EN-DCR;
- all studies included were required to provide the success rates of both MMC and control groups, and the followed up time was more than 6 months.
Key exclusion criteria (2 listed)
- studies which did not provide the success rates;
- studies which included pediatric cases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
success rate
Time frame: 6 months
Success was determined by the presence of any one of the following: (1) patent lacrimal passage on syringing, (2) symptomatic improvement, and (3) endoscopic visualisation of fluorescein dye at the nasal opening of the anastomoses.
1 secondary outcome
ostium size
Time frame: 12 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 13 Feb 2014.
- Derived from this study: PubMed 23675423Cheng SM, Feng YF, Xu L, Li Y, Huang JH. Efficacy of mitomycin C in endoscopic dacryocystorhinostomy: a systematic review and meta-analysis. PLoS One. 2013 May 13;8(5):e62737. doi: 10.1371/journal.pone.0062737. Print 2013.
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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.
Shiming Cheng, MD principal investigator
Eye Hospital, Wenzhou Medical College, China
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 Dacryocystitis, run by Yifan Feng 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 3 inclusion and 2 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 13 Feb 2014. 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?
success rate (time frame: 6 months). 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 NCT01772277, which also lists 1 linked publication.
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 13 Feb 2014.