- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05500950
Color Doppler Ultrasound in Lacrimal Sac Space-occupying Lesions
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Zhejiang
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Wenzhou, Zhejiang, China, 321000
- Eye Hospital and School of Ophthalmology and Optometry,Wenzhou Medical University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
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.
Exclusion Criteria:
Preoperative ultrasound or CT examination not completed.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
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patients with space occupying lesions in the lacrimal sac area completed CDU and CT-DCG or CT examination before surgery
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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2 weeks before surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Morphological changes of CT or CT-DCG in lacrimal sac space-occupying lesions
Time Frame: 2 weeks before surgery
|
2. 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.
|
2 weeks before surgery
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDU in lacrimal sac
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Supporting Information Type
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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