Nasolacrimal Sac Biopsy in Endoscopic Dacryocystorhinostomy

Predictive Value of Nasolacrimal Sac Biopsy in Endoscopic Dacryocystorhinostomy

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.

Study Overview

• Status: Completed
• Conditions: Dacryocystitis; Chronic
• Intervention / Treatment: Diagnostic test: biopsying

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11884
    • Azhar faculty of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This study includes fifty patients with chronic epiphora due to chronic nasal duct obstruction seeking for treatment by endoscopic intranasal dacryocystorhinostomy. Their age ranged from (20-70) years from both genders. They were selected from patients attending the Ophthalmology and Ear Nose Throat (ENT) clinics, at Al-Azhar University Hospital. Their referring ophthalmologist diagnosed all of the patients with lacrimal obstruction.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Al-Azhar University
• Investigators: Principal Investigator: Ibrahim El-dsoky, MD, Alazhar university

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): December 30, 2020
• Study Completion (Actual): March 9, 2021

Study Registration Dates

• First Submitted: March 8, 2021
• First Submitted That Met QC Criteria: March 9, 2021
• First Posted (Actual): March 11, 2021

Study Record Updates

• Last Update Posted (Actual): March 11, 2021
• Last Update Submitted That Met QC Criteria: March 9, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dacryocystitis
• Other Study ID Numbers: 19-11-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: journal pubication

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No