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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04793230
Other study ID # 19-11-002
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2019
Est. completion date March 9, 2021

Study information

Verified date March 2021
Source Al-Azhar University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

During dacryocystorhinostomy (DCR), the lacrimal sac wall biopsy is not routinely performed, but it is recommended if there is a suspicion of underlying disease other than preoperatively or intraoperatively chronic inflammation. We aimed to evaluate the utility of the histopathology examination of fifty patients in AlAzhar Hospitals to put recommendation for histopathology examination of such cases.


Description:

Most of patient with epiphora have different causes of nasolacrimal duct obstruction . This study aims to examine how important routine lacrimal sac biopsy is during endoscopic dacryocystorhinostomy surgery. The study included 50 patients with chronic unilateral epiphora. All patients underwent endoscopic dacryocystorhinostomy with nasolacrimal duct biopsy. Histopathologic analysis was performed for each specimen to assess the nature of the pathology.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date March 9, 2021
Est. primary completion date December 30, 2020
Accepts healthy volunteers No
Gender All
Age group 20 Years to 70 Years
Eligibility Inclusion Criteria: - Male and female patients with chronic lacrimal duct obstruction attended the outpatient clinic of the hospital for treatment during the study period. Exclusion Criteria: - Patients refusing the biopsy - Patients asked for histopathology in private laboratories

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
biopsying
The procedure was carried out under general or local anesthesia. An otolaryngologist conducts the endoscopic intranasal operation, while an eye surgeon removes tissue from the sac and lacrimal tubes using lacrimal probes passed through the canaliculi.

Locations

Country Name City State
Egypt Azhar faculty of medicine Cairo

Sponsors (1)

Lead Sponsor Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Microscopic examination using Hematoxylin and Eosin stains with special stain sending the biopsies to the pathology laboratory with completed request form then examination of the biopsies in the laboratory using the light microscope to assess the nature of the lesion with degree of inflammation according to the amount of lymphocytes to be classified as mild (10% cells), moderate (up to 50%) or severe (more than 50% lymphocytic cells) fourteen days
See also
  Status Clinical Trial Phase
Completed NCT05500950 - Color Doppler Ultrasound in Lacrimal Sac Space-occupying Lesions