Color Doppler Ultrasound in Lacrimal Sac Space-occupying Lesions

August 12, 2022 updated by: yin ying zhao, Wenzhou Medical University

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

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

Observational

Enrollment (Actual)

21

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Zhejiang
      • Wenzhou, Zhejiang, China, 321000
        • Eye Hospital and School of Ophthalmology and Optometry,Wenzhou Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
patients with space occupying lesions in the lacrimal sac area completed CDU and CT-DCG or CT examination before surgery

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.
2 weeks before surgery

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

April 30, 2022

Study Completion (Actual)

April 30, 2022

Study Registration Dates

First Submitted

July 8, 2022

First Submitted That Met QC Criteria

August 12, 2022

First Posted (Actual)

August 15, 2022

Study Record Updates

Last Update Posted (Actual)

August 15, 2022

Last Update Submitted That Met QC Criteria

August 12, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Personal participant data can be requested by email from the corresponding author

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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