Nasolacrimal Sac Biopsy in Endoscopic Dacryocystorhinostomy

NCT04793230 | Completed

• 1 other identifier: 19-11-002
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dacryocystitis; Chronic

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

biopsying DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \- Male and female patients with chronic lacrimal duct obstruction attended the outpatient clinic of the hospital for treatment during the study period.

You may not qualify if:

• Patients refusing the biopsy
• Patients asked for histopathology in private laboratories

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Azhar faculty of medicine

Cairo, 11884, Egypt

Location

MeSH Terms

Conditions

Dacryocystitis; Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Study Officials

• Ibrahim El-dsoky, MD

  Al-Azhar University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: pathology laboratory coordinator

Study Record Dates

• First Submitted: March 8, 2021
• First Posted: March 11, 2021
• Study Start: January 1, 2019
• Primary Completion: December 30, 2020
• Study Completion: March 9, 2021
• Last Updated: March 11, 2021

Record last verified: 2021-03

Locations

EG (1)