Dacryocystitis; ChronicNCT05500950
Color Doppler Ultrasound in Lacrimal Sac Space-occupying Lesions
An observational study of Dacryocystitis; Chronic and Lacrimal Sac Space-occupying Lesions, run by Wenzhou Medical University at 1 site in China.
Trial summary
Dacryocystitis and nasolacrimal duct obstruction are the main common causes of epiphora. Dacryocystorhinostomy (DCR) is a widely used and effective treatment for dacryocystitis and nasolacrimal duct obstruction. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Dacryocystitis; Chronic, Lacrimal Sac Space-occupying Lesions, Color Doppler Ultrasound
- What is being tested?
- CDU and CT-DCG or CT examination
- How many people
- 21 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 30 Apr 2022
- 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 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 21 patients who had completed color Doppler ultrasound and CT dacryocystography or CT examination before surgery and were diagnosed with lacrimal sac space-occupying lesions during EEDCR surgery were enrolled in this study.
Who may be able to join
- Clinical diagnosis of lacrimal sac space-occupying lesion. Lacrimal sac surgery must be completed. Must had completed color Doppler ultrasound and CT dacryocystography or CT examination before surgery.
Who cannot join
- Preoperative ultrasound or CT examination not completed.
Trial locations and contacts
1 site in 1 country.
China1 site
Eye Hospital and School of Ophthalmology and Optometry,Wenzhou Medical University
Wenzhou, Zhejiang, 321000
About this study
Official title: Application of Color Ultrasound Doppler and CT in the Diagnosis of Lacrimal Sac Space-occupying Lesions
Dacryocystitis and nasolacrimal duct obstruction are the main common causes of epiphora. Dacryocystorhinostomy (DCR) is a widely used and effective treatment for dacryocystitis and nasolacrimal duct obstruction. Among these cases, some patients have space-occupying lesions in the lacrimal sac area, such as dacryoliths, mucoceles, granulomas, and even tumors. For patients with lacrimal sac tumors, a more complex treatment plan needs to be adopted, and the severity of the disease and the complexity of treatment should be informed before surgery, since more than 55% of lacrimal sac tumors are malignant.
Therefore, preoperative diagnosis and identification of lacrimal sac space-occupying lesions is important. For lack of imaging examinations, and the symptoms of patients with space-occupying lesions are often similar to those of dacryocystitis and nasolacrimal duct obstruction, which lead to the diagnosis of lacrimal sac space-occupying lesions was not discovered before DCR. CDU has been used for the observation of lacrimal gland tumors. This study has attempted to assess the CDU and CT dacryocystography characteristics of the lacrimal sac space-occupying lesions.
Read the detailed description
A retrospective analysis was performed on the patients with lacrimal sac space-occupying lesions during endoscopic endonasal dacryocystorhinostomy（EEDCR） surgery in the Eye and Optometry Hospital Affiliated to Wenzhou Medical University from January 2018 to March 2022. Patients who had completed color Doppler ultrasound and CT dacryocystography or CT examination before surgery and were diagnosed with lacrimal sac space-occupying lesions during EEDCR surgery were selected to be included in this study. A total of 33 cases of lacrimal sac space-occupying lesions were found, however, preoperative ultrasound or CT examination was absent in 12 of them. Finally, 21 patients were enrolled in this study. We compared preoperative color Doppler ultrasonography and CT dacryocystography or CT examination in these 21 patients according to pathological diagnosis, and recorded the success rate of DCR and the recurrence rate of lacrimal sac space-occupying lesions at follow-up.
CDU was performed in all patients were examined in the supine position. The skin corresponding to the lacrimal fossa region were coated with disinfectant coupling agent, then the probe was placed over the skin and moved in transverse and cranio-caudal directions. A qualitative assessment of the size of the lacrimal sac, sac content, and surrounding structures was first performed in B-mode. Then, color Doppler ultrasound was used to analyze whether there is blood supply in the lacrimal sac space-occupying lesions. CT-DCG images were acquired after injection of a water-soluble iodinated contrast medium through the lower lacrimal punctum, with the layer thickness from 1mm to 5mm.
The fundamental information of all patients is recorded as follows: age, sex, side of involvement, duration of epiphora and history of lacrimal system intervention. All the space-occupying lesions obtained during surgery were sent for pathological examination. All patients were followed up for more than 1 month.
- Conditions
- Dacryocystitis; Chronic, Lacrimal Sac Space-occupying Lesions, Color Doppler Ultrasound, Computed Tomography
- Being tested
- CDU and CT-DCG or CT examination
- Keywords
- Color Doppler ultrasound, lacrimal sac space-occupying lesions, nasolacrimal duct obstruction, Computed Tomography
- Medical subject headings
- Dacryocystitis, Bronchiolitis Obliterans Syndrome, Lacrimal Duct Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDU and CT-DCG or CT examinationOther
patients with space occupying lesions in the lacrimal sac area completed CDU and CT-DCG or CT examination before surgery
| Study group | Role | What they receive |
|---|---|---|
| Patients with space occupying lesions completed CDU and CT-DCG or CT | Patients who had completed CDU and CT-DCG or CT examination before surgery and were diagnosed with lacrimal sac space occupying lesions during surgery were selected to be included in this study. Receives: Other: CDU and CT-DCG or CT examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphological changes of color Doppler ultrasound in lacrimal sac space-occupying lesions
Conventional ultrasonography and color Doppler ultrasonography images are used to assess the characteristics of lacrimal sac space-occupying lesions. Percentage of patients with clear or unclear borders, even or uneven internal echogenicity, regular or irregular shape, with or without blood flow signals of different kinds of lacrimal sac space-occupying lesions was recorded.
Measured: 2 weeks before surgery
Secondary outcomes (1)
Morphological changes of CT or CT-DCG in lacrimal sac space-occupying lesions
- CT or CT-DCG images are used to assess the characteristics of lacrimal sac space-occupying lesions. Percentage of patients with Regular or irregular shape of different kinds of lacrimal sac space-occupying lesions were recorded. Percentage of the space-occupying lesions in the lacrimal sac invade the surrounding bone was also analyzed.
Measured: 2 weeks before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2022
- Study start1 Jan 2018
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dacryocystitis; ChronicStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yin ying zhao, Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05500950
- Sponsor's protocol ID
- CDU in lacrimal sac
- Status last verified
- Aug 2022
- First submitted
- 8 Jul 2022
- Last updated
- 15 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Personal participant data can be requested by email from the corresponding author
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Color Ultrasound Doppler and CT in the Diagnosis of Lacrimal Sac Space-occupying Lesions
- ClinicalTrials.gov ID
- NCT05500950
- Acronym / sponsor ID
- CDU in lacrimal sac
- Conditions
- Dacryocystitis; Chronic, Lacrimal Sac Space-occupying Lesions, Color Doppler Ultrasound, Computed Tomography
- Keywords
- Color Doppler ultrasound, lacrimal sac space-occupying lesions, nasolacrimal duct obstruction, Computed Tomography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 15 Aug 2022 (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.
Dacryocystitis and nasolacrimal duct obstruction are the main common causes of epiphora. Dacryocystorhinostomy (DCR) is a widely used and effective treatment for dacryocystitis and nasolacrimal duct obstruction. Among these cases, some patients have space-occupying lesions in the lacrimal sac area, such as dacryoliths, mucoceles, granulomas, and even tumors. For patients with lacrimal sac tumors, a more complex treatment plan needs to be adopted, and the severity of the disease and the complexity of treatment should be informed before surgery, since more than 55% of lacrimal sac tumors are malignant.
Therefore, preoperative diagnosis and identification of lacrimal sac space-occupying lesions is important. For lack of imaging examinations, and the symptoms of patients with space-occupying lesions are often similar to those of dacryocystitis and nasolacrimal duct obstruction, which lead to the diagnosis of lacrimal sac space-occupying lesions was not discovered before DCR. CDU has been used for the observation of lacrimal gland tumors. This study has attempted to assess the CDU and CT dacryocystography characteristics of the lacrimal sac space-occupying lesions.
Detailed description
A retrospective analysis was performed on the patients with lacrimal sac space-occupying lesions during endoscopic endonasal dacryocystorhinostomy（EEDCR） surgery in the Eye and Optometry Hospital Affiliated to Wenzhou Medical University from January 2018 to March 2022. Patients who had completed color Doppler ultrasound and CT dacryocystography or CT examination before surgery and were diagnosed with lacrimal sac space-occupying lesions during EEDCR surgery were selected to be included in this study. A total of 33 cases of lacrimal sac space-occupying lesions were found, however, preoperative ultrasound or CT examination was absent in 12 of them. Finally, 21 patients were enrolled in this study. We compared preoperative color Doppler ultrasonography and CT dacryocystography or CT examination in these 21 patients according to pathological diagnosis, and recorded the success rate of DCR and the recurrence rate of lacrimal sac space-occupying lesions at follow-up.
CDU was performed in all patients were examined in the supine position. The skin corresponding to the lacrimal fossa region were coated with disinfectant coupling agent, then the probe was placed over the skin and moved in transverse and cranio-caudal directions. A qualitative assessment of the size of the lacrimal sac, sac content, and surrounding structures was first performed in B-mode. Then, color Doppler ultrasound was used to analyze whether there is blood supply in the lacrimal sac space-occupying lesions. CT-DCG images were acquired after injection of a water-soluble iodinated contrast medium through the lower lacrimal punctum, with the layer thickness from 1mm to 5mm.
The fundamental information of all patients is recorded as follows: age, sex, side of involvement, duration of epiphora and history of lacrimal system intervention. All the space-occupying lesions obtained during surgery were sent for pathological examination. All patients were followed up for more than 1 month.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with space occupying lesions completed CDU and CT-DCG or CT | – | Other: CDU and CT-DCG or CT examinationPatients who had completed CDU and CT-DCG or CT examination before surgery and were diagnosed with lacrimal sac space occupying lesions during surgery were selected to be included in this study. |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 21 patients who had completed color Doppler ultrasound and CT dacryocystography or CT examination before surgery and were diagnosed with lacrimal sac space-occupying lesions during EEDCR surgery were enrolled in this study.
Key inclusion criteria (1 listed)
- Clinical diagnosis of lacrimal sac space-occupying lesion. Lacrimal sac surgery must be completed. Must had completed color Doppler ultrasound and CT dacryocystography or CT examination before surgery.
Key exclusion criteria (1 listed)
- Preoperative ultrasound or CT examination not completed.
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 |
|---|---|---|
| CDU and CT-DCG or CT examinationpatients with space occupying lesions in the lacrimal sac area completed CDU and CT-DCG or CT examination before surgery | Other | Patients with space occupying lesions completed CDU and CT-DCG or CT |
Primary outcome
Morphological changes of color Doppler ultrasound in lacrimal sac space-occupying lesions
Time frame: 2 weeks before surgery
Conventional ultrasonography and color Doppler ultrasonography images are used to assess the characteristics of lacrimal sac space-occupying lesions. Percentage of patients with clear or unclear borders, even or uneven internal echogenicity, regular or irregular shape, with or without blood flow signals of different kinds of lacrimal sac space-occupying lesions was recorded.
1 secondary outcome
Morphological changes of CT or CT-DCG in lacrimal sac space-occupying lesions
Time frame: 2 weeks before surgery
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 15 Aug 2022.
- Individual participant dataSharing planned: Yes. Personal participant data can be requested by email from the corresponding author
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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.
The record lists no contact. Use the official record to reach the sponsor.
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; Chronic and Lacrimal Sac Space-occupying Lesions, run by Wenzhou Medical 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 1 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 15 Aug 2022. 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?
Morphological changes of color Doppler ultrasound in lacrimal sac space-occupying lesions (time frame: 2 weeks before surgery). 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 15 Aug 2022.