Nasolacrimal Sac Biopsy in Endoscopic Dacryocystorhinostomy

Dacryocystitis; Chronic Clinical Trial

Official title:

Predictive Value of Nasolacrimal Sac Biopsy in Endoscopic Dacryocystorhinostomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04793230
• Other study ID #: 19-11-002
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Dacryocystitis
• Dacryocystitis; Chronic

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