Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05500950 |
| Other study ID # |
CDU in lacrimal sac |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2018 |
| Est. completion date |
April 30, 2022 |
Study information
| Verified date |
August 2022 |
| Source |
Wenzhou Medical University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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.
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.
