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Nasolacrimal Sac Biopsy in Endoscopic Dacryocystorhinostomy

Sponsor
Al-Azhar University (Other)
Overall Status
Completed
CT.gov ID
NCT04793230
Collaborator
(none)
50
Enrollment
1
Location
26.2
Actual Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
50 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Predictive Value of Nasolacrimal Sac Biopsy in Endoscopic Dacryocystorhinostomy
Actual Study Start Date :
Jan 1, 2019
Actual Primary Completion Date :
Dec 30, 2020
Actual Study Completion Date :
Mar 9, 2021

Outcome Measures

Primary Outcome Measures

  1. Microscopic examination using Hematoxylin and Eosin stains with special stain [fourteen days]

    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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Azhar faculty of medicine Cairo Egypt 11884

Sponsors and Collaborators

  • Al-Azhar University

Investigators

  • Principal Investigator: Ibrahim El-dsoky, MD, ALAZHAR UNIVERSITY

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Abdulkarim Hasan, pathology laboratory coordinator, Al-Azhar University
ClinicalTrials.gov Identifier:
NCT04793230
Other Study ID Numbers:
  • 19-11-002
First Posted:
Mar 11, 2021
Last Update Posted:
Mar 11, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Dacryocystitis

Study Results

No Results Posted as of Mar 11, 2021