NCT05500950

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 15, 2022

Completed
Last Updated

August 15, 2022

Status Verified

August 1, 2022

Enrollment Period

4.3 years

First QC Date

July 8, 2022

Last Update Submit

August 12, 2022

Conditions

Keywords

Color Doppler ultrasoundlacrimal sac space-occupying lesionsnasolacrimal duct obstructionComputed Tomography

Outcome Measures

Primary Outcomes (1)

  • 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.

    2 weeks before surgery

Secondary Outcomes (1)

  • Morphological changes of CT or CT-DCG in lacrimal sac space-occupying lesions

    2 weeks before surgery

Study Arms (1)

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.

Other: CDU and CT-DCG or CT examination

Interventions

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

Patients with space occupying lesions completed CDU and CT-DCG or CT

Eligibility Criteria

Age10 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • Preoperative ultrasound or CT examination not completed.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eye Hospital and School of Ophthalmology and Optometry,Wenzhou Medical University

Wenzhou, Zhejiang, 321000, China

Location

MeSH Terms

Conditions

DacryocystitisBronchiolitis Obliterans SyndromeLacrimal Duct Obstruction

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye DiseasesOrganizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host DiseaseImmune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Chief Physician

Study Record Dates

First Submitted

July 8, 2022

First Posted

August 15, 2022

Study Start

January 1, 2018

Primary Completion

April 30, 2022

Study Completion

April 30, 2022

Last Updated

August 15, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will share

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

Shared Documents
CSR

Locations